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Recruiting Phase 1 NCT05039801

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Trial Parameters

Condition Advanced Endometrial Carcinoma
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 54
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-09-09
Completion 2026-05-29
All Conditions
Advanced Endometrial Carcinoma Advanced Head and Neck Squamous Cell Carcinoma Advanced Malignant Solid Neoplasm Advanced Melanoma Advanced Ovarian Clear Cell Adenocarcinoma Chondrosarcoma Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Pathologic Stage III Cutaneous Melanoma AJCC v8 Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8 Pathologic Stage IV Cutaneous Melanoma AJCC v8 Recurrent Ovarian High Grade Serous Adenocarcinoma Refractory Endometrial Carcinoma Refractory Head and Neck Squamous Cell Carcinoma Refractory Melanoma Refractory Ovarian Clear Cell Adenocarcinoma Refractory Ovarian High Grade Serous Adenocarcinoma Stage III Ovarian Cancer AJCC v8 Stage III Uterine Corpus Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Uterine Corpus Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Uterine Corpus Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Uterine Corpus Cancer AJCC v8 Stage IIIC1 Uterine Corpus Cancer AJCC v8 Stage IIIC2 Uterine Corpus Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Uterine Corpus Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Uterine Corpus Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Uterine Corpus Cancer AJCC v8
Interventions
BevacizumabGlutaminase-1 Inhibitor IACS-6274Paclitaxel

Brief 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.

Eligibility Criteria

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/STK11/NF1 mutations Patients with low ASNS expression levels (HGSOC or endometrial cancer) Patients who had immunotherapy (IO) melanoma (Minimum treatment duration of prior PD-1 or PD-L1-containing regimen of 12 weeks \[or equivalent of 2 response evaluations\]). Patients with post-platinum HNSCC Patients with chondrosarcoma Patients with ARID1A mutant clear cell ovarian cancer Dose Escalation for Part B ma

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