Phase 2 Melanoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to participate
• People who have a confirmed locally advanced or metastatic solid tumour (cancer that has spread) that has continued to grow despite standard treatment, for which no standard treatment exists, or where standard treatment could not be tolerated
• People who have not taken an experimental drug within the past 4 weeks (or within 5 half-lives of that drug, whichever is shorter), and who are not already enrolled in another clinical study
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
• People whose heart, kidney, and liver function results, along with heart rhythm tests, fall within acceptable ranges when tested within 28 days of joining
• People who are able to provide either a recent tumour tissue sample (taken by needle biopsy) or stored tumour tissue collected within the past 12 months (note: people whose tumour is in a location that makes biopsy risky may be able to join without a fresh sample, subject to approval from the study organisers)
• People who are not pregnant; women who could become pregnant and have partners who have not had a vasectomy must agree to use effective contraception from the first dose (or 14 days before if using oral contraception) until 7 months after the last dose; men who have not had a vasectomy and whose partners could become pregnant must agree to use barrier contraception and not donate sperm from the first dose until 4 months after the last dose
• People who have measurable cancer that can be tracked using standard imaging criteria (RECIST v1.1)

For specific groups in Phase 1 expansion (in addition to the above):

• People with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received no more than 3 prior treatments for advanced disease
• People with locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC) who have received no more than 3 prior treatments for advanced disease
• People with locally advanced, recurrent, or metastatic ovarian cancer whose cancer returned during or within 6 months of platinum-based chemotherapy (called platinum-resistant), and who have received no more than 1 treatment since becoming platinum-resistant (note: maintenance therapy with certain targeted drugs such as PARP inhibitors or bevacizumab does not count as a separate treatment line)
• People with any locally advanced or metastatic solid tumour that has a specific genetic change called an AKT3 mutation or amplification, confirmed by a genetic test called next-generation sequencing (NGS)

For Phase 2 (in addition to the general criteria above):

• People with confirmed advanced skin melanoma (Stage III or IV), NSCLC, or kidney cancer (RCC) that has continued to grow on a type of immunotherapy called anti-PD-1 therapy, confirmed by imaging
• People whose most recent treatment was an anti-PD-1 therapy regimen, and for whom a doctor considers it appropriate to restart or continue that therapy alongside the study drug GIM-531
• People with melanoma or kidney cancer that does not have the BRAF gene mutation who have received no more than 2 prior treatments for advanced disease
• People with NSCLC or melanoma that has a specific BRAF (V600) gene mutation who have received no more than 3 prior treatments for advanced disease

Who may not be able to join:

• People who still have significant side effects (above a mild level) from a previous cancer treatment, with the exception of certain types of hair loss or mild nerve-related sensory changes
• People with cancer that has spread to the lining around the brain, is compressing the spinal cord, or has spread to the brain — unless the brain metastases have been treated and have been stable for at least 4 weeks before starting the study, the person has no ongoing neurological symptoms related to those brain metastases, and any steroid use for brain metastases is either stopped or at a low stable or decreasing dose below a certain threshold (confirm with trial site)
• People with a known structural heart problem
• People with a known serious heart rhythm disorder, a history of a condition called long QT syndrome, or other significant heart conduction problems
• People with an active autoimmune disease that has required systemic medical treatment (such as immune-suppressing drugs or corticosteroids) within the past 12 months — note that hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment and are permitted
• People who are currently taking steroid tablets or injections at a dose of 10 mg per day of prednisone or more, or any other immune-suppressing medication at the time of screening (note: steroid creams, inhalers, nasal sprays, or eye drops are permitted)
• People with an active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B, hepatitis C, or HIV
• People who have a history of, or currently have, a condition that significantly weakens the immune system, whether present from birth or developed over time
• People who have received chemotherapy or immune-modifying cancer treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug
• People who have received a live vaccine within 30 days before the first dose of the study drug
• People who have had major surgery within 2 weeks before the first dose, or have major surgery planned within that period
• People who are unable to swallow oral capsules or tablets
• People who are taking certain medications that strongly affect how the body processes drugs (specifically strong inducers or inhibitors of CYP2C8 or CYP3A4/5, or certain drug transport proteins called P-gp and BCRP), if those medications cannot be stopped at least 1 week before the first dose and for the duration of the study (confirm specific medications with trial site)
• People who are taking medications that change the acidity of the stomach, such as proton-pump inhibitors (e.g. omeprazole) or H2 blockers (e.g. famotidine) — note that standard antacids such as calcium carbonate or aluminium hydroxide products are permitted

Important: Always verify eligibility with the trial site directly before applying.