Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06220864




Registration number
NCT06220864
Ethics application status
Date submitted
12/01/2024
Date registered
24/01/2024
Date last updated
4/06/2024

Titles & IDs
Public title
SNV1521 in Participants With Advanced Solid Tumors
Scientific title
A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
SNV1521-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SNV1521

Experimental: Dose Escalation -

Experimental: Dose Expansion -


Treatment: Drugs: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of SNV1521
Timepoint [1] 0 0
From first dose through last dose (up to 13 months)
Primary outcome [2] 0 0
Tolerability of SNV1521
Timepoint [2] 0 0
DLTs: From first dose through completion of first cycle (28 days)

Eligibility
Key inclusion criteria
- Advanced or metastatic solid tumor malignancy

- Refractory to or intolerant of available therapies

- Evaluable or Measurable disease (RECIST 1.1 Criteria).

- ECOG Performance Status 0 or 1.

- Life expectancy > 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active brain metastasis or carcinomatous meningitis

- History of other malignancy within the past 2 years

- Significant cardiovascular disease within 6 months

- Significant gastrointestinal disease

- HIV infection with a CD4+ T-cell count < 200 cells/µL and/or a detectable viral load

- Liver dysfunction

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
23/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Linear Clinical Research - Crawley
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
6009 - Crawley
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
United States of America
State/province [3] 0 0
Utah

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is testing a new medicine, SNV1521, for people with advanced cancers. The
researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating
solid tumors. They are investigating different doses in order to find the most effective and
safe one.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06220864
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
rcasper@synnovationtx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06220864