First-in-Human, Phase 1, Open-label Study to Evaluate the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of MTX-531, a Dual EGFR/PI3K Inhibitor, as Monotherapy in Adults With Advanced Solid Tumors
MEKanistic Therapeutics, Inc.
Summary
This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess how the drug is processed by the body and its preliminary anti-tumor activity.
Description
This first-in-human, Phase 1, open-label study will evaluate MTX-531, an investigational small-molecule inhibitor of EGFR and PI3K, as monotherapy in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531 and determine the maximum tolerated dose (MTD) and provisional recommended Phase 2 dose (RP2D). The study will also characterize the pharmacokinetic (PK) profile of MTX-531 and evaluate its preliminary clinical activity. Safety assessments will include adverse events, dose-limiting toxicities, laboratory assessments, vital signs, and electrocardiog…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Age 1. Age ≥18 years at the time of signing the informed consent. Disease Characteristics 2. Has one of the following types of advanced or refractory solid tumor malignancy: EC - No specific requirement 1. FIGO stage III or IV (unresectable, recurrent, or metastatic disease) at study entry 2. Received 1, 2, or 3 prior systemic regimens in any setting that must include: i. Anti-PD(L)1 in any setting (unless contraindicated) ii. A platinum-containing chemotherapy in any setting c. Adjuvant/neoadjuvant chemotherapy with or without additional anti-cancer the…
Interventions
- DrugMTX-531
MTX-531 is an investigational small-molecule dual EGFR/PI3K inhibitor administered as monotherapy in adults with advanced solid tumors. Dose levels will be evaluated during dose escalation to assess safety, tolerability, pharmacokinetics, and preliminary clinical activity.
Location
- Hoag Memorial Hospital PresbyterianNewport Beach, California