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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
6/03/2025

Titles & IDs
Public title
SNV4818 in Participants with Advanced Solid Tumors
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
Secondary ID [1] 0 0
SNV4818-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicities (DLTs)
Assessment method [1] 0 0
-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
Timepoint [1] 0 0
First 28 days of study treatment
Primary outcome [2] 0 0
Treatment Emergent Adverse Events (TEAEs)
Assessment method [2] 0 0
Incidence and frequency of TEAEs
Timepoint [2] 0 0
From first SNV4818 dose through approximately 30 days following the last SNV4818 dose
Secondary outcome [1] 0 0
Maximum observed plasma concentration of SNV4818
Assessment method [1] 0 0
Cmax
Timepoint [1] 0 0
After 4 weeks (1 cycle) of study treatment
Secondary outcome [2] 0 0
Time to reach the maximum observed plasma concentration of SNV4818
Assessment method [2] 0 0
Tmax
Timepoint [2] 0 0
After 4 weeks (1 cycle) of study treatment
Secondary outcome [3] 0 0
Area Under Plasma Concentration (AUC) Time Curve of SNV4818
Assessment method [3] 0 0
AUC0-t
Timepoint [3] 0 0
After 4 weeks (1 cycle) of study treatment
Secondary outcome [4] 0 0
Half-life of SNV4818
Assessment method [4] 0 0
t1/2
Timepoint [4] 0 0
After 4 weeks (1 cycle) of study treatment
Secondary outcome [5] 0 0
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
Assessment method [5] 0 0
AUC0-infinity
Timepoint [5] 0 0
After 1 day of study treatment
Secondary outcome [6] 0 0
Apparent oral clearance of SNV4818
Assessment method [6] 0 0
CL/F
Timepoint [6] 0 0
After 4 weeks (1 cycle) of study treatment
Secondary outcome [7] 0 0
Apparent volume of distribution of SNV4818
Assessment method [7] 0 0
Vz/F
Timepoint [7] 0 0
After 4 weeks (1 cycle) of study treatment
Secondary outcome [8] 0 0
Overall response rate (ORR)
Assessment method [8] 0 0
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
Timepoint [8] 0 0
After 8 weeks on study treatment
Secondary outcome [9] 0 0
Disease control rate (DCR)
Assessment method [9] 0 0
The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better
Timepoint [9] 0 0
After 8 weeks on study treatment
Secondary outcome [10] 0 0
Duration of response (DOR)
Assessment method [10] 0 0
The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.
Timepoint [10] 0 0
Up to approximately 2 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,W. Australi
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Tennessee
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Synnovation Therapeutics, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Robert Casper
Address 0 0
Country 0 0
Phone 0 0
443-764-9527
Email 0 0
rcasper@synnovationtx.com
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