OncoMatch/Clinical Trials/NCT06425926
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Is NCT06425926 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including GIM-531 and Anti-PD-1 monoclonal antibody for melanoma stage iv.
Treatment: GIM-531 · Anti-PD-1 monoclonal antibody — GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Tumor Agnostic
Biomarker criteria
Required: AKT3 mutation
Participants with known AKT3 mutation ... based on next generation sequencing (NGS) performed per local standard of care.
Required: AKT3 amplification
Participants with known AKT3 ... amplification based on next generation sequencing (NGS) performed per local standard of care.
Required: BRAF wild-type
BRAF wild-type melanoma or RCC: Participants must have received no more than 2 prior lines of therapy in the advanced/metastatic setting
Required: BRAF V600 mutation
BRAF (V600) mutant melanoma or NSCLC: Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting.
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — latest line
Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma, NSCLC, or RCC that has radiographically progressed ... on an approved single-agent or combination anti-PD-1 therapy; must have received the anti-PD-1 therapy containing regimen as the latest line of treatment
Must have received: platinum-based chemotherapy — ovarian cancer, platinum-resistant
Participants must have platinum-resistant ovarian cancer defined as disease recurrence or within 6 months after the last administration of platinum-based chemotherapy
Cannot have received: experimental drug
Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is shorter) of study drug treatment or already be enrolled in a clinical study
Cannot have received: chemotherapeutic agents or immune modulating agents
Has had prior anti-cancer treatment with chemotherapeutic agents or immune modulating agents within <4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study drug.
Lab requirements
Kidney function
acceptable renal function per protocol
Liver function
acceptable hepatic function per protocol
Cardiac function
acceptable cardiac function per protocol; exclusion of known structural cardiac disease, serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities
Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions; Has known structural cardiac disease; Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth Research Institute · Scottsdale, Arizona
- Comprehensive Blood and Cancer Center · Bakersfield, California
- Providence Medical Foundation · Fullerton, California
- The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate · Los Angeles, California
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
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