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Clinical Trial 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.


Clinical Trial 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 as monotherapy (Part A) in patients with or without biomarker selected tumor types. II. To assess the preliminary antitumor activity of IACS-6274 in the combination with bevacizumab and weekly paclitaxel (Part B) in patients with recurrent platinum-resistant ovarian cancer and in combination with capivasertib (Part C) for all solid tumors. III. To characterize the pharmacokinetics (PK) profile of IACS-6274 as a monotherapy (Part A) and in combination with bevacizumab and weekly paclitaxel (Part B) in the combination with capivasertib (Part C). To evaluate biomarkers of patient stratification and correlate them with clinical outcome. EXPLORATORY OBJECTIVE: I. To collect biobank samples for potential future analysis of biomarkers (optional, informed consent required). OUTLINE: This is a dose-escalation study of IACS-6274 followed by a dose-expansion study. Patients are assigned to 1 of 2 parts. PART A: Patients receive IACS-6274 orally (PO) throughout the study. PART B: Patients receive IACS-6274 PO, paclitaxel intravenously (IV), and bevacizumab IV throughout the study. PART C: Patients receive IACS-627 PO, with capivasertib PO throughout the study. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Endometrial Carcinoma
  • Advanced Head and Neck Squamous Cell Carcinoma
  • Advanced Malignant Solid Neoplasm
  • Advanced Melanoma
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Squamous Cell
  • Chondrosarcoma
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Endometrial Neoplasms
  • Melanoma
  • Ovarian Neoplasms
  • 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
  • Refractory Endometrial Carcinoma
  • Refractory Melanoma
  • Refractory Ovarian Clear Cell Adenocarcinoma
  • Skin Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • 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

NCT number NCT05039801
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Timothy Timothy, MD
Phone 713-563-1930
Email tyap@mdanderson.org
Status Recruiting
Phase Phase 1
Start date September 9, 2021
Completion date May 29, 2026

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