Actively Recruiting
A Phase 1 Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 Alone and in Combination for Advanced Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-06-01
54
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of the oral glutaminase inhibitor IACS-6274 as a single treatment and in combination with other drugs for patients with advanced solid tumors. The study aims to find the highest dose patients can tolerate when IACS-6274 is given alone, with bevacizumab and paclitaxel, or with capivasertib. This phase 1 trial also looks at how the drug behaves in the body and its preliminary effects on tumors in different patient groups, including those with specific genetic markers or cancer types. Participants are assigned to one of three groups: Part A receives IACS-6274 by mouth alone; Part B receives IACS-6274 orally along with paclitaxel and bevacizumab given intravenously; Part C receives IACS-6274 orally with capivasertib by mouth. The study includes a dose-escalation phase to determine safe dosing and a dose-expansion phase to further evaluate the treatments. Some patients may also choose to provide tissue samples for future biomarker studies. During the trial, patients will have regular assessments including physical exams, imaging scans, and laboratory tests to monitor safety, drug effects, and tumor response. Researchers will track adverse events for up to 90 days after treatment begins. The study requires patients to have measurable tumor lesions and adequate organ function. Participation includes ongoing monitoring of heart function and the collection of biopsy samples where feasible. The study is expected to continue until mid-2028.
CONDITIONS
Brief Title
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Male or female adults aged 18 years or older
- Have histologically or cytologically confirmed advanced solid tumors meeting specific mutation or biomarker profiles
- Received at least one prior therapy for advanced disease and be refractory or ineligible for existing treatments
- Completed prior chemotherapy, radiotherapy, immunotherapy, or investigational treatment at least 3 weeks before study start with side effects resolved or stable
- Have available fresh or archival tumor tissue for biomarker analysis
- Have at least one measurable or assessable lesion suitable for repeated imaging
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no recent deterioration
- Adequate organ function based on specified laboratory values
- Adequate cardiac function with left ventricular ejection fraction 50% or higher
- Female patients of non-childbearing potential or using effective contraception if of childbearing potential
- Male patients using condoms or abstinence if sexually active with partners of childbearing potential
You will not qualify if you...
- Prior malignancy within 2 years except certain cured localized cancers
- Known primary central nervous system malignancy or symptomatic brain metastases
- Uncontrolled or recent serious cardiac conditions including unstable arrhythmias and significant heart disease
- Major surgery within 28 days before study drug or planned during study
- Significant acute or chronic infections
- Psychiatric conditions preventing informed consent
- Recent treatment with strong CYP3A4 or CYP2D6 interacting drugs
- Radiotherapy within 4 weeks before study drug (exceptions for palliative treatment)
- Severe or uncontrolled systemic diseases or bleeding disorders
- Allergic reactions to similar drugs in the study
- History of alcohol or drug abuse
- Inability to swallow oral medications as required
- Known hypersensitivity to study drugs or components
- Specific risks related to Part B (e.g., hypersensitivity to paclitaxel/bevacizumab, bowel obstruction, proteinuria, bleeding risk, pre-existing neuropathy)
- Specific risks related to Part C (e.g., diabetes, liver disease, abnormal glucose metabolism, active infections including tuberculosis, hepatitis, HIV with certain criteria, concurrent anticancer treatments)
- Other medical or laboratory findings that may interfere with study participation or pose risk as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment varies by participant until disease progression or discontinuation
Participants receive the study drugs orally and/or intravenously depending on their assigned group throughout the study to assess safety and antitumor activity.
Weekly visits for treatment administration and monitoring
Duration - Up to 90 days after treatment completion
Participants are monitored for safety and adverse events after treatment ends for up to 90 days.
1 to 2 visits depending on adverse events
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Timothy A Yap, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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