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Glutaminase Inhibitor

IACS-6274 +/− Bevacizumab/Paclitaxel for Cancer

Phase 1
Recruiting
Led By Timothy A Yap, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with ARID1A mutant clear cell ovarian cancer
Female patients of childbearing potential, who are not post-menopausal or surgically sterile and intent to be sexually active with a non-sterile male partner, are required to use one form of highly effective contraception combined with a barrier method
Must not have
Legal incapacity or limited legal capacity
Part C Specific Exclusion Criteria (C4) Patients with evidence of severe or uncontrolled systemic liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it's safe and effective in treating patients with advanced solid tumors. The new drug, 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.

Who is the study for?
Adults with advanced solid tumors, including specific types of ovarian, uterine, head and neck cancers, melanoma, and chondrosarcoma. Participants must have adequate organ function and no severe recent illnesses or treatments that could interfere with the study. They should not be at high risk for bleeding or infection and must use effective contraception if applicable.
What is being tested?
The trial is testing IACS-6274 alone or in combination with other drugs like bevacizumab (which inhibits blood vessel growth in tumors), paclitaxel (a chemotherapy drug), or capivasertib (targets cancer cell growth). The goal is to find the highest dose patients can tolerate without significant side effects.
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; increased risk of infections; possible allergic reactions; issues related to liver function; nerve damage manifesting as numbness or tingling; and complications from affecting normal blood vessel formation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian cancer is ARID1A mutant clear cell type.
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I am a woman able to have children, not menopausal or surgically sterile, and will use effective birth control.
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My ovarian cancer is high-grade, non-mucinous, platinum-resistant, and I've had less than 5 treatments.
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I am mostly active and haven't gotten worse in the past 2 weeks.
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I finished any cancer treatments 3 weeks ago or longer, and my side effects are minimal or stable.
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I will use a condom during the trial and for 16 weeks after if I'm sexually active.
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My cancer has low ASNS expression levels.
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I have head and neck cancer that has returned or continued after platinum-based chemotherapy.
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I've had at least one treatment for my advanced disease and can't use or didn't respond to standard treatments.
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My cancer is confirmed to be advanced and not just in one place.
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My organ functions are within normal ranges according to recent tests.
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My tumor has specific genetic changes (KEAP1/NFE2L2/STK11/NF1).
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I have at least one tumor that can be measured by scans.
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I have been diagnosed with chondrosarcoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am legally unable to make my own decisions.
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I do not have severe or uncontrolled liver disease.
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I do not have any recent serious illnesses, especially heart-related.
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I haven't had major surgery in the last 28 days and don't expect any during the study.
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I am currently dealing with a serious infection.
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I am not on any cancer treatments or medications that could affect the study.
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I am HIV-positive but meet specific health criteria.
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I cannot swallow pills without changing their form.
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I do not have any serious heart conditions.
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I do not have an active tuberculosis infection.
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I do not have pre-existing nerve damage in my hands or feet.
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I do not have ongoing side effects from past cancer treatments.
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I have a primary brain tumor or symptoms from brain metastases.
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I have never had bowel obstruction, abdominal fistula, gastrointestinal perforation, or abscesses.
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I do not have an active hepatitis infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part B (IACS-6274, bevacizumab, paclitaxel)Experimental Treatment3 Interventions
Patients receive IACS-6274 PO, paclitaxel IV, and bevacizumab IV throughout the study.
Group II: Part A (IACS-6274)Experimental Treatment1 Intervention
Patients receive IACS-6274 PO throughout the study.
Group III: PART C: (IACS-6274) with capivasertibExperimental Treatment2 Interventions
Patients receive IACS-627 PO, with capivasertib PO throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Paclitaxel
2011
Completed Phase 4
~5370
Capivasertib
2021
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,170 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
Timothy A Yap, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
479 Total Patients Enrolled

Media Library

IACS-6274 (Glutaminase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05039801 — Phase 1
Cutaneous Melanoma Research Study Groups: Part B (IACS-6274, bevacizumab, paclitaxel), PART C: (IACS-6274) with capivasertib, Part A (IACS-6274)
Cutaneous Melanoma Clinical Trial 2023: IACS-6274 Highlights & Side Effects. Trial Name: NCT05039801 — Phase 1
IACS-6274 (Glutaminase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039801 — Phase 1
~17 spots leftby May 2026
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