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About
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).
Full description
GIM531-CT01 is a Phase 1/2 open label, first-in-human, multicenter study. The Phase 1 portion will include a dose escalation with GIM-531 administered as a single agent. Additionally, there will be a dose expansion portion at the safety-cleared dose levels with participants allocated 1:1 within the proposed therapeutic range to accrue additional data for determining the safety profile, pharmacokinetics (PK) profile, pharmacodynamic (PD) effects and early anti-tumor activity of GIM-531. In Phase 2, GIM-531will be administered to participants with advanced/metastatic cutaneous melanoma who have progressed following treatment with an anti-PD-1 therapy.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Phase 2 Specific Inclusion Criteria (in addition to above inclusion criteria):
Key Exclusion Criteria:
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 melanoma with documented BRAF mutation (Phase 2 only)
Has known brain metastases, except participants with the following:
Note: Neurological symptoms that are considered sequelae to treatment for brain metastases are allowed.
Primary purpose
Allocation
Interventional model
Masking
84 participants in 2 patient groups
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Central trial contact
Jayadev Sureddi, CBCC CRO
Data sourced from clinicaltrials.gov
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