Testing SNV4818 for advanced solid tumors
Official title: A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
Run by Pikavation Therapeutics, Inc. · NCT06736704 · Data updated 2026-11-12
This study is testing a new medication called SNV4818 to see if it can safely help people with advanced solid tumors that have a specific genetic mutation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | Pikavation Therapeutics, Inc. Industry-sponsored |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Status | Recruiting |
| Started | February 20, 2025 |
| Main results expected | April 2027 |
| Study ends | June 2027 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT06736704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with advanced or metastatic solid tumors that have an activating PIK3CA mutation and who have not responded to or cannot tolerate existing therapies.
✕Probably not a fit
Patients with primary CNS malignancies, active brain metastases, or significant organ dysfunction are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is evaluating the safety, tolerability, and effectiveness of a new medication called SNV4818 in patients with advanced solid tumors that have a specific genetic mutation. The study aims to determine the optimal dosing of SNV4818 while monitoring its effects on the participants' conditions. Patients enrolled in the trial must have tumors that are either refractory to existing treatments or intolerant to them, and their disease must be measurable according to established criteria.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have gone: Other studies targeting PIK3CA mutations in solid tumors have shown promise, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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
Where it's running
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The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Thomas Jefferson University-Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States Recruiting -
Sarah Cannon Research Institute
Nashville, Tennessee, United States Recruiting -
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States Recruiting -
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia Recruiting
Show 6 more locations
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Scientia Clinical Research
Randwick, New South Wales, Australia Recruiting -
Monash Health
Clayton, Victoria, Australia Recruiting -
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia Recruiting -
Linear Clinical Research
Nedlands, Western Australia, Australia Recruiting -
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada Recruiting -
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Robert Casper
- Email: rcasper@synnovationtx.com
- Phone: 443-764-9527
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.