A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced Solid Tumors
M.D. Anderson Cancer Center
Summary
To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.
Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of oral glutaminase inhibitor IPN60090 (IACS-6274) as monotherapy (Part A) and in combination therapy with bevacizumab and weekly paclitaxel (Part B) and in combination with capivasertib (Part C) II. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IACS-6274 in combination with bevacizumab and weekly paclitaxel (Part B). and of the combination of IACS-6274 and capivasertib (Part C). (For Dose Escalation Only) SECONDARY OBJECTIVES: I. To assess the preliminary antitumor activity of IACS-6274…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria All Parts 1. Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities. 3. Histologically or cytologically confirmed advanced solid tumors, specifically: Dose Escalation for Part A may include: Patients with tumors harboring actionable KEAP1/NFE2L2/S…
Interventions
- BiologicalBevacizumab
Given IV
- DrugGlutaminase-1 Inhibitor IACS-6274
Given by PO
- DrugPaclitaxel
Given by IV (vein)
- DrugCapivasertib
Given by PO
Location
- M D Anderson Cancer CenterHouston, Texas