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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06736704
Registration number
NCT06736704
Ethics application status
Date submitted
12/12/2024
Date registered
17/12/2024
Date last updated
26/06/2025
Titles & IDs
Public title
SNV4818 in Participants With Advanced Solid Tumors
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Scientific title
A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
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Secondary ID [1]
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SNV4818-101
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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:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SNV4818
Treatment: Drugs - Fulvestrant
Experimental: SNV4818 Monotherapy - Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.
Experimental: SNV4818+Fulvestrant Combination - Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.
Treatment: Drugs: SNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Treatment: Drugs: Fulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
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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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Incidence of dose limiting toxicities (DLTs)
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Assessment method [1]
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-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
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Timepoint [1]
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First 28 days of study treatment
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Primary outcome [2]
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Treatment Emergent Adverse Events (TEAEs)
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Assessment method [2]
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Incidence and frequency of TEAEs
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Timepoint [2]
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From first SNV4818 dose through approximately 30 days following the last SNV4818 dose
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Secondary outcome [1]
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Maximum observed plasma concentration of SNV4818
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Assessment method [1]
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Cmax
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Timepoint [1]
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After 4 weeks (1 cycle) of study treatment
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Secondary outcome [2]
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Time to reach the maximum observed plasma concentration of SNV4818
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Assessment method [2]
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Tmax
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Timepoint [2]
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After 4 weeks (1 cycle) of study treatment
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Secondary outcome [3]
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Area Under Plasma Concentration (AUC) Time Curve of SNV4818
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Assessment method [3]
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AUC0-t
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Timepoint [3]
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After 4 weeks (1 cycle) of study treatment
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Secondary outcome [4]
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Half-life of SNV4818
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Assessment method [4]
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t1/2
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Timepoint [4]
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After 4 weeks (1 cycle) of study treatment
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Secondary outcome [5]
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Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
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Assessment method [5]
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AUC0-infinity
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Timepoint [5]
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After 1 day of study treatment
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Secondary outcome [6]
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Apparent oral clearance of SNV4818
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Assessment method [6]
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CL/F
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Timepoint [6]
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After 4 weeks (1 cycle) of study treatment
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Secondary outcome [7]
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Apparent volume of distribution of SNV4818
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Assessment method [7]
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Vz/F
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Timepoint [7]
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After 4 weeks (1 cycle) of study treatment
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Secondary outcome [8]
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Overall response rate (ORR)
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Assessment method [8]
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The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
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Timepoint [8]
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After 8 weeks on study treatment
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Secondary outcome [9]
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Disease control rate (DCR)
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Assessment method [9]
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The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better
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Timepoint [9]
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After 8 weeks on study treatment
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Secondary outcome [10]
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Duration of response (DOR)
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Assessment method [10]
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The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.
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Timepoint [10]
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Up to approximately 2 years
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Eligibility
Key inclusion criteria
* Advanced or metastatic solid tumor with an activating PIK3CA mutation.
* Refractory to or intolerant of available therapies
* Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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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
* Diagnosis of a primary CNS malignancy
* Active brain metastases or carcinomatous meningitis
* Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
* Inadequate organ function
* Clinically significant ECG abnormalities, including QTcF = 470 ms
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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
Parallel
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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
20/02/2025
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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
1/12/2026
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,W. Australi
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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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Scientia Clinical Research - Randwick
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Recruitment hospital [3]
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Monash Health - Clayton
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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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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Pennsylvania
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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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Tennessee
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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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Texas
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Country [4]
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Canada
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State/province [4]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pikavation Therapeutics, 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 testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
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Trial website
https://clinicaltrials.gov/study/NCT06736704
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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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Address
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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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Robert Casper
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Address
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Country
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Phone
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443-764-9527
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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/NCT06736704
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