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Tests treatment safety and results for Melanoma Stage IV
Official title Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06425926
What this study is testing
What is GIM-531?
GIM-531 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for melanoma stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent
- Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard...
- 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...
- ECOG performance status 0-1
- Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions
You likely can't join if
- Ongoing \>Grade 1 toxicity from prior therapy according to Common Terminology Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2...
- Has known leptomeningeal disease, spinal cord compression, or brain metastases, except participants with the following:
- Brain metastases that have been treated and are clinically stable for at least 4 weeks prior to the first administration of study drug; Note...
- No ongoing neurological symptoms related to the anatomic location of the brain metastases. Note: Neurological symptoms that are considered sequelae...
- Has known structural cardiac disease
- Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities
See the full eligibility criteria
Who can join
- Written informed consent
- Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exist; or be intolerant of standard therapy
- 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
- ECOG performance status 0-1
- Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions
- Agree to baseline core needle biopsy or archival (within 12 months of screening) tumor submission; Note: Participants whose only site(s) of disease are in areas considered moderate or high risk for biopsy complications...
- Non pregnant participants; female participants of child bearing potential with non-sterile partners agree to use an effective form of contraception from the time of first dose of study drug (or 14 days prior to first...
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 Phase 1 Expansion Cohorts Specific (in addition to above ):
- NSCLC: Participants must have locally advanced/unresectable or metastatic NSCLC. Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting.
- TNBC: Participants must have locally advanced unresectable, recurrent, or metastatic TNBC. Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting.
- Ovarian Cancer: Participants must have locally advanced unresectable, recurrent, or metastatic ovarian cancer. Participants must have platinum-resistant ovarian cancer defined as disease recurrence or within 6 months...
- Tumors with AKT3 mutation/amplification: Participants must have a locally advanced unresectable, recurrent, or metastatic solid malignancy. Participants with known AKT3 mutation/amplification based on next generation...
- Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma, NSCLC, or RCC that has radiographically progressed (as confirmed by imaging assessed by the Investigator) on an approved single-agent or...
- Must have received the anti-PD-1 therapy containing regimen as the latest line of treatment and be eligible to restart or to continue anti-PD-1 therapy in combination with GIM-531
- BRAF wild-type melanoma or RCC: Participants must have received no more than 2 prior lines of therapy in the advanced/metastatic setting
- BRAF (V600) mutant melanoma or NSCLC: Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting. Key
What rules you out
- Ongoing \>Grade 1 toxicity from prior therapy according to Common Terminology Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2 sensory neuropathy are not exclusionary)
- Has known leptomeningeal disease, spinal cord compression, or brain metastases, except participants with the following:
- Brain metastases that have been treated and are clinically stable for at least 4 weeks prior to the first administration of study drug; Note: Participants receiving steroids for brain metastases must be either off...
- No ongoing neurological symptoms related to the anatomic location of the brain metastases. Note: Neurological symptoms that are considered sequelae to treatment for brain metastases are allowed.
- Has known structural cardiac disease
- Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities
- Has an active autoimmune disease that has required systemic treatment in the past 12 months (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine...
- At time of screening, is receiving systemic steroid therapy (greater than or equal to 10 mg/day of prednisone or equivalent) or is taking any immunosuppressive therapy; Note: Use of topical, inhaled, nasal, or...
- Has active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Has a history of, or currently has, an acquired or primary (congenital) immunodeficiency;
- 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.
- Has received a live vaccine within 30 days of first dose of study drug;
- Has had or has planned major surgery within 2 weeks of the first dose of study drug;
- Inability to swallow an oral dose of a medication (eg, oral capsules)
- Is taking medications that are considered strong inducers or inhibitors of CYP2C8 or CYP3A4/5, P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), or sensitive substrates of P-gp and BCRP (Appendix C) that...
- Is taking drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids such as calcium carbonate or aluminum hydroxide-based products are permitted.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Bakersfield, California, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Billings, Montana, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Bakersfield, California, United States; Fullerton, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Boston, Massachusetts, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.