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IACS-6274 for Advanced Solid Tumors

This study is testing a new drug called IACS-6274, alone or with other drugs like bevacizumab, paclitaxel, or capivasertib, for people with advanced solid tumors, including certain types of endometrial, head and neck, melanoma, and ovarian cancers. The main goal is to find the highest safe dose of IACS-6274 and see how well patients tolerate it. Researchers will also look for early signs of the treatment working against the cancer. You can join if you are 18 or older and have advanced solid tumors. The study is also looking at specific markers (biomarkers) in your tumor, like ARID1A or PIK3CA, to understand how they relate to treatment outcomes.

Study design
This is an interventional study with a planned enrollment of 54 participants. It aims to assess the safety and tolerability of IACS-6274 as a single treatment and in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The incidence of adverse events (side effects) will be measured for up to 90 days.

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NCT05039801

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~54 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:BevacizumabGlutaminase-1 Inhibitor IACS-6274PaclitaxelCapivasertib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 90 days

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

Explore related trials

ChondrosarcomaEndometrial CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmMelanomaSolid NeoplasmASNS GeneAT-Rich Interactive Domain-Containing Protein 1AKelch-Like ECH-Associated Protein 1NF1 GeneNFE2L2 GenePIK3CA GeneProtein Kinase BPTEN GeneSTK11 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Timothy A Yap, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Timothy A Yap, MD
[email protected]
713-563-1930
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Total/true abstinence is defined as a patient who refrains from any form of sexual intercourse, and this is in line with their usual and/or preferred lifestyle.

Exclusion

cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association. 4. Major surgical intervention within 28 days before study drug administration, or an anticipated need for major surgery during the study. 5. Significant acute or chronic infections. 6. Any psychiatric condition that would prohibit the understanding or rendering of informed consent. 7. Treatment with strong cytochrome P450 subtype 3A4 (CYP3A4) inducers and inhibitors (including grapefruit juice) within 2 weeks of the first dose of study drug NOTE: patients must have stopped taking St. John's Wort 3 weeks prior to the start of treatment and stopped taking enzalutamide 4 weeks prior to the start of treatment. 8. Treatment with strong CYP450 subtype 2D6 (CYP2D6) inhibitors or sensitive CYP3A4 substrates within 7 days of the first dose of study drug. 9. Radiotherapy within 4 weeks prior to the start of study drug. Palliative radiotherapy for symptomatic control is acceptable if completed at least 2 weeks prior to study drug administration and no additional radiotherapy for the same lesion is planned. 10. Underlying medical conditions (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases), for which in the investigator's opinion will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or AEs. 11. History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the compounds in the study. 12. Known history of alcohol or drug abuse. 13. Legal incapacity or limited legal capacity. 14. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses (such as refractory nausea and vomiting, chronic gastrointestinal disease or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretionof IACS-6274 and capivasertib, which are oral agents. 15. Patients unwilling to comply with protocol requirements related to the assigned part. 16. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
Mean resting corrected QT interval \>470ms, obtained from triplicate ECGs performed at screening.
Medical history significant for arrhythmia that is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation regardless of treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be included based on the study physician's judgment.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia of Grade ≥1, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relative, history of QT prolongation associated with other medications that required discontinuation of the medication.
Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association Grade ≥2.
Uncontrolled hypotension: SBP \<90 mmHg and/or DBP \<50 mmHg.
Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \[MUGA\] scan if an echocardiogram cannot be performed or is inconclusive).

What this trial measures

  • Incidence of adverse events (AEs)Up to 90 days

    Will be assessed by the rate of dose limiting toxicities at each dose level in the dose escalation, and the rate of AEs and the rate of Grade 3 and higher AEs in the dose escalation and dose expansion. All AEs will be coded according to the latest version of Medical Dictionary for Regulatory Activities and National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.