Clinical Trials Logo

Clinical Trial Summary

This phase I trial tests the safety, side effects, and best dose of IACS-6274 with or without pembrolizumab in treating patients with solid tumors that have spread to other places in the body (advanced). IACS-6274 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving IACS-6274 with or without pembrolizumab may help to control the disease.


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 pembrolizumab (Part B). II. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IACS-6274 in combination therapy with pembrolizumab (Part B). (For Dose Escalation Only) SECONDARY OBJECTIVES: I. To assess the preliminary antitumor activity of IACS-6274 as monotherapy (Part A) and in combination with pembrolizumab (Part B) in patients with or without biomarker selected tumor types. II. To characterize the pharmacokinetics (PK) and pharmacodynamic (PD) profile of IACS-6274 as a monotherapy (Part A) and in combination with pembrolizumab (Part B). III. 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) twice daily (BID) on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. PART B: Patients receive IACS-6274 PO BID on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. Part B patients are also followed up at 60 and 90 days. ;


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 High Grade Ovarian Serous Adenocarcinoma
  • 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
Status Recruiting
Phase Phase 1
Start date September 9, 2021
Completion date May 29, 2026

See also
  Status Clinical Trial Phase
Suspended NCT03253679 - AZD1775 in Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification Phase 2
Withdrawn NCT03925428 - Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas Phase 1
Not yet recruiting NCT05039632 - NBTXR3, Radiation Therapy, Ipilimumab, and Nivolumab for the Treatment of Lung and/or Liver Metastases From Solid Malignancy Phase 1/Phase 2
Recruiting NCT02389309 - Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors Phase 1
Recruiting NCT03065387 - Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation Phase 1
Active, not recruiting NCT04552704 - CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study Phase 1/Phase 2
Not yet recruiting NCT04939090 - Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients Phase 3
Not yet recruiting NCT05038839 - Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors Phase 1
Active, not recruiting NCT03698994 - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT03210714 - Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT02451553 - Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer Phase 1
Recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Not yet recruiting NCT04090619 - Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers
Active, not recruiting NCT01480154 - Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer Phase 1
Completed NCT03291938 - IACS-010759 in Advanced Cancers Phase 1
Recruiting NCT01434316 - Veliparib and Dinaciclib in Treating Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04439344 - Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A) Phase 2
Active, not recruiting NCT04439201 - Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B) Phase 2
Active, not recruiting NCT04439123 - Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) Phase 2
Completed NCT04439214 - Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D) Phase 2