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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06956690
Registration number
NCT06956690
Ethics application status
Date submitted
24/04/2025
Date registered
4/05/2025
Date last updated
6/05/2025
Titles & IDs
Public title
A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With HER3-Expressing Solid Tumors
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Scientific title
A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors
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Secondary ID [1]
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ENV-ONC-501
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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:
Melanoma (Skin)
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Non Small Cell Lung Cancer
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Breast Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - ENV-501
Experimental: ENV-501 - ENV-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of ENV-501 until the RP2D is reached
Treatment: Other: ENV-501
ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.
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Intervention code [1]
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Treatment: Other
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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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Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events
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Assessment method [1]
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Timepoint [1]
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through study completion, an average of 6 months
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Primary outcome [2]
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Phase 2 (Dose Expansion): Objective Response Rate (ORR)
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Assessment method [2]
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Objective Response is defined as Complete Response (CR) or Partial Response (PR) by investigator assessment, measured by revised Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
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Timepoint [2]
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through study completion, an average of 6 months
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Secondary outcome [1]
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Phase 1 (Dose Escalation): Disease Control Rate (DCR)
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Assessment method [1]
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DCR is defined as CR, PR, or Stable Disease (SD) by investigator assessment, measured by revised RECIST 1.1.
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Timepoint [1]
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through study completion, an average of 6 months
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Secondary outcome [2]
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Phase 1 (Dose Escalation): Objective Response Rate (ORR)
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Assessment method [2]
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Timepoint [2]
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through study completion, an average of 6 months
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Secondary outcome [3]
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Phase 1 (Dose Escalation): maximum blood concentration (Cmax) after a single dose
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Assessment method [3]
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Timepoint [3]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [4]
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Phase 1 (Dose Escalation): time of maximum blood concentration (Tmax) after a single dose
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Assessment method [4]
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Timepoint [4]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [5]
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Phase 1 (Dose Escalation): absorption to time t (AUC0-t) after a single dose
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Assessment method [5]
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AUC represents "area under the concentration-time curve" and measures the amount of drug that is present in the blood from the time of administration to a given time 't'
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Timepoint [5]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [6]
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Phase 1 (Dose Escalation): absorption to end of the dosing period (AUC0-tau) after a single dose
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Assessment method [6]
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Timepoint [6]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [7]
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Phase 1 (Dose Escalation): total absorption (AUC0-infinity) after a single dose
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Assessment method [7]
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Timepoint [7]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [8]
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Phase 1 (Dose Escalation): drug half-life (t1/2) after a single dose
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Assessment method [8]
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Timepoint [8]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [9]
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Phase 1 (Dose Escalation): minimum blood concentration (Cmin) after a single dose
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Assessment method [9]
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Timepoint [9]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [10]
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Phase 1 (Dose Escalation): rate of clearance (CL) after a single dose
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Assessment method [10]
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Timepoint [10]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [11]
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Phase 1 (Dose Escalation): steady-state volume of distribution (Vss) after a single dose
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Assessment method [11]
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Timepoint [11]
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At the end of Cycle 1 (each cycle is 21 days)
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Secondary outcome [12]
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Phase 1 (Dose Escalation): Cmax at steady state
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Assessment method [12]
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Timepoint [12]
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through study completion, an average of 6 months
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Secondary outcome [13]
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Phase 1 (Dose Escalation): Tmax at steady state
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Assessment method [13]
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Timepoint [13]
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through study completion, an average of 6 months
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Secondary outcome [14]
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Phase 1 (Dose Escalation): AUC0-t at steady state
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Assessment method [14]
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Timepoint [14]
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through study completion, an average of 6 months
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Secondary outcome [15]
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0
Phase 1 (Dose Escalation):AUC0-tau at steady state
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Assessment method [15]
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Timepoint [15]
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through study completion, an average of 6 months
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Secondary outcome [16]
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Phase 1 (Dose Escalation): t1/2 at steady state
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Assessment method [16]
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Timepoint [16]
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through study completion, an average of 6 months
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Secondary outcome [17]
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Phase 1 (Dose Escalation): Cmin at steady state
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Assessment method [17]
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Timepoint [17]
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through study completion, an average of 6 months
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Secondary outcome [18]
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Phase 1 (Dose Escalation): accumulation ratio at steady state
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Assessment method [18]
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Timepoint [18]
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through study completion, an average of 6 months
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Secondary outcome [19]
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Phase 2 (Dose Expansion): Disease Control Rate (DCR)
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Assessment method [19]
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Timepoint [19]
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through study completion, an average of 6 months
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Secondary outcome [20]
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Phase 2 (Dose Expansion): Duration of Response (DoR)
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Assessment method [20]
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A DoR event is defined as disease progression or death due to any cause in the subset of patients who achieved CR or PR on the study. DoR will be calculated from the date of first radiographic evidence of objective response by RECIST v1.1 to the date of progression, date of death, or date of last follow-up, whichever is the earliest.
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Timepoint [20]
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through study completion, an average of 6 months
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Secondary outcome [21]
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Phase 2 (Dose Expansion): Progression-free Survival (PFS)
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Assessment method [21]
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A PFS event is defined as disease progression or death due to any cause. PFS will be calculated from the date of treatment start to the date of progression, date of death, or date of last follow-up, whichever is the earliest.
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Timepoint [21]
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through study completion, an average of 6 months
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Secondary outcome [22]
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Phase 2 (Dose Expansion): Frequency of treatment-emergent adverse events
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Assessment method [22]
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Timepoint [22]
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through study completion, an average of 6 months
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Secondary outcome [23]
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Phase 2 (Dose Expansion): Cmax at steady state
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Assessment method [23]
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Timepoint [23]
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through study completion, an average of 6 months
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Secondary outcome [24]
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Phase 2 (Dose Expansion): Cmin at steady state
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Assessment method [24]
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Timepoint [24]
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through study completion, an average of 6 months
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Eligibility
Key inclusion criteria
* Body weight = 40 kg.
* Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
* Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:
1. Unresectable or metastatic cutaneous melanoma (HER3+)
2. Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
3. Unresectable, locally advanced or metastatic hormone receptor (HR)+/human epidermal growth factor receptor 2 (HER2)- breast cancer (HER3+)
* If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for assessment of HER3+ status.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
* Contraceptive requirements:
1. Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.
2. Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.
* Females must:
1. Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.
2. Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.
* Males must:
1. Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.
2. Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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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
* Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:
1. Any anti-tumor-directed drug therapy within 21 days or 5 times the elimination half-life (whichever is shorter).
2. Treatment with investigational drugs within 21 days.
3. Major surgery within 21 days.
4. Radiation therapy =4 weeks or radiotherapy that included >30% of the bone marrow.
5. Autologous or allogeneic stem cell transplantation or allogeneic tissue/organ transplant within 3 months.
6. CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) =4 half-lives.
7. CYP3A4 strong inducer =4 half-lives.
8. OATP1B inhibitor (including any prescription or non-prescription drugs or herbal supplements) =4 half-lives.
* Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy.
* Prior treatment with a topoisomerase I inhibitor as last line of therapy.
* Primary immune deficiency (e.g. congenital syndromes).
* Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment within 2 weeks prior to study start.
* Known/suspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients.
* History of noninfectious or drug-induced pneumonitis or interstitial lung disease (ILD).
* Known seropositivity (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
* Leptomeningeal disease, symptomatic or uncontrolled (active) brain metastasis (note: brain metastases not requiring steroids or anti-epileptic therapy are allowed if stable for =4 weeks prior to study start and patient is neurologically stable).
* Pregnant or WOCBP who have a positive b-human chorionic gonadotropin (HCG) test result at Screening or within 7 days prior to study start.
* Patients with second malignancies that are active (uncontrolled, metastatic) or requiring therapy.
* Patient who is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study site or the Sponsor.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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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
Single group
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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
1/05/2025
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Actual
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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
1/07/2027
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Actual
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Sample size
Target
180
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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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Research Site - Campbelltown
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Recruitment hospital [2]
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Research Site - Miranda
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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2228 - Miranda
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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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Michigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Endeavor Biomedicines, 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
This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of ENV-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). The primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of ENV-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of ENV-501. The results of the dose escalation will determine the RP2D and dosing schedule of ENV-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of ENV-501 in dose expansion cohorts.
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Trial website
https://clinicaltrials.gov/study/NCT06956690
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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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Lisa Lancaster, M.D.
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Address
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Endeavor Biomedicines
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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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Endeavor Clinical Trials
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Address
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Country
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Phone
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1-858-727-3199
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT06956690
Download to PDF