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IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced Solid Tumors

NCT05039801•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•2. Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities.
•3. Histologically or cytologically confirmed advanced solid tumors, specifically:
•Dose Escalation for Part A may include:
•Patients with tumors harboring actionable KEAP1/NFE2L2/STK11/NF1 mutations Patients with low ASNS expression levels (HGSOC or endometrial cancer) Patients who had immunotherapy (IO) melanoma (Minimum treatment duration of prior PD-1 or PD-L1-containing regimen of 12 weeks \[or equivalent of 2 response evaluations\]).
•Patients with post-platinum HNSCC Patients with chondrosarcoma Patients with ARID1A mutant clear cell ovarian cancer
•Dose Escalation for Part B may include:
•Confirmed recurrent high-grade non-mucinous ovarian cancer that is platinum-resistant, defined as disease relapse within a platinum-free interval (PFI, or the time elapsed from the last date of platinum dose until PD) of \< 6 months, and with less than 5 prior therapies
•Dose Expansion for Part B limited to:
•Confirmed recurrent high-grade non-mucinous ovarian cancer with low ASNS expression levels that is platinum-resistant, defined as disease relapse within a PFI of \< 6 months, and with less than 5 prior therapies.
+30 more criteria

Exclusion Criteria

•1. Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder.
•2. Known primary central malignancy or symptomatic central nervous system metastasis(es).
•Note: Patients with stable, previously treated brain metastases may participate if neurologic symptoms have resolved, patients have been off steroids (at least 7 days for Part A and Part B, and at least 4 weeks for Part C), and there is no evidence of disease progression by imaging for at least 2 weeks before the first dose of study treatment.
•3. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following cardiac conditions:
•1. Any unstable cardiac arrhythmia within 6 months prior to enrolment
•2. Prolongation of the Fridericia corrected QT (QTcF) interval defined as \>450 ms for males and \>470 ms for females
•3. History of any of the following cardiovascular conditions within 6 months of enrolment:
•* 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.
+34 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 9, 2021

Primary Completion Date

May 29, 2026

Completion Date

May 29, 2026

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell CarcinomaAdvanced Malignant Solid NeoplasmAdvanced MelanomaAdvanced Ovarian Clear Cell AdenocarcinomaChondrosarcomaClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Pathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Recurrent Ovarian High Grade Serous AdenocarcinomaRefractory Endometrial CarcinomaRefractory Head and Neck Squamous Cell CarcinomaRefractory MelanomaRefractory Ovarian Clear Cell AdenocarcinomaRefractory Ovarian High Grade Serous AdenocarcinomaStage III Ovarian Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8

Interventions

Bevacizumab

BIOLOGICAL

Glutaminase-1 Inhibitor IACS-6274

DRUG

Paclitaxel

DRUG

Capivasertib

DRUG

Contacts

Timothy A Yap, MD

CONTACT

713-563-1930 tyap@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)

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