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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05039801
Phase
PHASE1
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Glutaminase-1 Inhibitor IACS-6274 — DRUG
    Given by PO
  • Paclitaxel — DRUG
    Given by IV (vein)
  • Capivasertib — DRUG
    Given by PO

Study Details

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.

Key Dates

Start date
Sep 30, 2021
Status verified
May 2026
Primary completion
Mar 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (IACS-6274)
    Patients receive IACS-6274 PO throughout the study.
  • Experimental: Part B (IACS-6274, bevacizumab, paclitaxel)
    Patients receive IACS-6274 PO, paclitaxel IV, and bevacizumab IV throughout the study.
  • Experimental: PART C: (IACS-6274) with capivasertib
    Patients receive IACS-627 PO, with capivasertib PO throughout the study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Timothy A. Yap, MD
[email protected]
713-563-1930
Timothy A. Yap, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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