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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06521554
Registration number
NCT06521554
Ethics application status
Date submitted
22/07/2024
Date registered
26/07/2024
Date last updated
17/06/2025
Titles & IDs
Public title
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
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Scientific title
A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
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Secondary ID [1]
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NVL-330-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Solid Tumor
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Metastatic Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - NVL-330
Experimental: Phase 1a dose escalation - NVL-330 oral daily dosing
Experimental: Phase 1b dose expansion - NVL-330 oral daily dosing
Treatment: Drugs: NVL-330
Oral Tablet of NVL-330
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recommended Phase 2 Dose (RP2D)
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Assessment method [1]
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To determine up to 2 RP2D Candidates
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Timepoint [1]
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As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
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Primary outcome [2]
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Maximum Tolerated Dose (MTD)
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Assessment method [2]
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If applicable, to determine the MTD
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Timepoint [2]
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As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
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Primary outcome [3]
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Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
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Assessment method [3]
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Number of participants with TEAEs as assessed by CTCAE, v5.0
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Timepoint [3]
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First dose of study drug through 30 days after the last dose of study drug
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Secondary outcome [1]
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Effect of Food on Maximum Plasma Concentration (Cmax) of NVL-330
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Assessment method [1]
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To determine the effect of food on maximum plasma concentration (Cmax) of NVL-330
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Timepoint [1]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [2]
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Effect of Food on Area Under the Curve from Time 0 to 24 (AUC0-24) of NVL-330
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Assessment method [2]
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To determine the effect of food on area under the curve from time 0 to 24 of NVL-330
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Timepoint [2]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [3]
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Effect of Food on Area Under the Curve from Time 0 to Infinity (AUCinf) of NVL-330
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Assessment method [3]
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To determine the effect of food on area under the curve from time 0 to infinity of NVL-330
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Timepoint [3]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [4]
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Effect of Food on Time of Maximum Concentration (Tmax) of NVL-330
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Assessment method [4]
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To determine the effect of food on time of maximum concentration of NVL-330
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Timepoint [4]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [5]
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Maximum plasma concentration (Cmax) of NVL-330
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Assessment method [5]
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To determine the maximum plasma concentration (Cmax) of NVL-330
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Timepoint [5]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [6]
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Maximum plasma concentration (Cmax- dose normalized) of NVL-330
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Assessment method [6]
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To determine the maximum plasma concentration (Cmax-dose normalized) of NVL-330
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Timepoint [6]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [7]
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Plasma concentration at the end of the dosing interval (Ctau) of NVL-330
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Assessment method [7]
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To determine the plasma concentration at the end of the dosing interval (Ctau) of NVL-330
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Timepoint [7]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [8]
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Plasma concentration 24 hours post-dose (C24) of NVL-330
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Assessment method [8]
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To determine the plasma concentration 24 hours post-dose (C24) of NVL-330
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Timepoint [8]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [9]
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Average plasma concentration (Cavg) of NVL-330
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Assessment method [9]
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To determine the average plasma concentration (Cavg) of NVL-330
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Timepoint [9]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [10]
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Time of maximum concentration (Tmax) of NVL-330
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Assessment method [10]
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To determine the time of maximum concentration (Tmax) of NVL-330
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Timepoint [10]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [11]
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Area Under the Curve at the End of the Dosing Interval (AUCtau) of NVL-330
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Assessment method [11]
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To determine the area under the curve at the end of the dosing interval (AUCtau) of NVL-330
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Timepoint [11]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [12]
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Area Under the Curve at the End of the Dosing Interval (AUCtau - dose normalized) of NVL-330
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Assessment method [12]
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To determine the area under the curve at the end of the dosing interval (AUCtau - dose normalized) of NVL-330
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Timepoint [12]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [13]
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Area Under the Curve From Time 0 to 24 (AUC0-24) of NVL-330
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Assessment method [13]
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To determine the area under the curve from time 0 to 24 (AUC0-24) of NVL-330
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Timepoint [13]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [14]
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Area Under the Curve From Time 0 to 24 (AUC0-24 - dose normalized) of NVL-330
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Assessment method [14]
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To determine the area under the curve from time 0 to 24 (AUC0-24 - dose normalized) of NVL-330
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Timepoint [14]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [15]
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Area Under the Curve From Time 0 to Infinity (AUCinf) of NVL-330
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Assessment method [15]
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To determine the area under the curve from time 0 to infinity (AUCinf) of NVL-330
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Timepoint [15]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [16]
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Area Under the Curve From Time 0 to Infinity (AUCinf - dose normalized) of NVL-330
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Assessment method [16]
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To determine the area under the curve from time 0 to infinity (AUCinf - dose normalized) of NVL-330
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Timepoint [16]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [17]
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Oral clearance (CL/F) of NVL-330
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Assessment method [17]
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To determine the oral clearance (CL/F) of NVL-330
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Timepoint [17]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [18]
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Volume of Distribution (Vz/F) of NVL-330
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Assessment method [18]
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To determine the volume of distribution (Vz/F) of NVL-330
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Timepoint [18]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [19]
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Accumulation Ratio of NVL-330
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Assessment method [19]
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To determine the ratio of accumulation of NVL-330
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Timepoint [19]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [20]
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Half-life (t1/2) of NVL-330
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Assessment method [20]
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To determine the half-life (t1/2) of NVL-330
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Timepoint [20]
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Pre-dose and up to 24 hours post-dose
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Secondary outcome [21]
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Objective Response Rate (ORR)
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Assessment method [21]
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Objective Response Rate (ORR) as determined by RECIST 1.1 criteria
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Timepoint [21]
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2 -3 years after first patient dosed
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Secondary outcome [22]
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Duration of Response (DOR)
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Assessment method [22]
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Time from first investigator-assessed response to radiographic disease progression or death
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Timepoint [22]
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2 to 3 years after first patient dosed
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Secondary outcome [23]
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Intracranial Objective Response Rate (IC-ORR)
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Assessment method [23]
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The proportion of patients with a confirmed intracranial response (IC-CR or IC-PR)
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Timepoint [23]
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2 to 3 years after first patient dosed
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Secondary outcome [24]
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Intracranial Duration of Response (IC-DOR)
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Assessment method [24]
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The time from first investigator-assessed intracranial response to radiographic intracranial disease progression or death
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Timepoint [24]
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2 to 3 years after first patient dosed
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Secondary outcome [25]
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Time to Response (TTR)
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Assessment method [25]
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The time from first dose to first confirmed radiographic response
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Timepoint [25]
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Approximately 3 years
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Eligibility
Key inclusion criteria
1. Age = 18 years
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
3. Documented HER2 status as follows:
1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.
2. Phase 1b: Documented oncogenic HER2 mutation.
4. Identification of lesions as follows:
1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1.
2. Phase 1b: Must have measurable disease, defined as = 1 radiologically measurable target lesion according to RECIST 1.1.
5. Adequate organ function and bone marrow reserve
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient's cancer has known oncogenic driver alteration other than HER2
2. Known allergy/hypersensitivity to excipients of NVL-330
3. Major surgery within 4 weeks of the first dose of study drug
4. Ongoing or recent anticancer therapy
5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2026
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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North Shore Health Hub - Saint Leonards
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Recruitment postcode(s) [1]
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NSW 2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - Saint Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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District of Columbia
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Tennessee
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Country [11]
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United States of America
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State/province [11]
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Texas
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Country [12]
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United States of America
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State/province [12]
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Virginia
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Country [13]
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United States of America
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State/province [13]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Nuvalent Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced or metastatic HER2-altered NSCLC. Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL 330 in patients with advanced or metastatic HER2 mutant NSCLC.
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Trial website
https://clinicaltrials.gov/study/NCT06521554
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Steve Margossian, MD PhD
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Address
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Nuvalent Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lisa Morelli
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Address
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Country
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Phone
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857-357-7000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06521554
Download to PDF