Testing SNV4818 for advanced solid tumors

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

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
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pikavation Therapeutics, Inc. (industry)
• Locations: 12 sites (Los Angeles, California and 11 other locations)
• Trial ID: NCT06736704 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with primary CNS malignancies, active brain metastases, or significant organ dysfunction are unlikely to benefit from this study.

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 performed: Other studies targeting PIK3CA mutations in solid tumors have shown promise, indicating that this approach may be effective.

Eligibility 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 this trial is running

Los Angeles, California and 11 other locations

• 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)
• 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

Conditions: Advanced Solid Tumors