🏛️ Verified NIH Record • Updated 2026-07-30
M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (NCT02595931)
🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (15 items).
Location: Los Angeles General Medical Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who have had chemotherapy or other systemic therapy or radiotherapy or patients who have not recovered from adverse events due to prior administered agents as follows:
- Chemotherapy \< 4 weeks prior to entering the study
- Radiotherapy \< 4 weeks prior to entering the study
- Nitrosoureas/mitomycin C \< 6 weeks prior to entering the study
- Targeted therapy \< 2 weeks (or 5 half-lives, whichever is longer) prior to entering the study
- Those who have not recovered from clinically significant adverse events due to prior agents administered to grade =\< 1 or baseline, with exception of alopecia and peripheral neuropathy, unless approved by the protocol chair
- Immunotherapy \< 4 weeks prior to entering the study
- Patients who are receiving any other investigational agents
- Patients with unstable brain metastases should be excluded; however, patients with known brain metastases may participate in this clinical trial if they are clinically stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on a stable or decreasing dose of steroids for at least 14 days prior to trial treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970, berzosertib) or irinotecan
- M6620 (VX-970, berzosertib) is primarily metabolized by CYP3A4; irinotecan and its active metabolite, SN-38, are metabolized by CYP3A4 and UGT1A1, respectively; therefore, concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; valproic acid is known to inhibit the process of glucuronidation and may potentially enhance the toxicity of irinotecan; medications that enhance glucuronidation (i.e. phenytoin, phenobarbital, carbamazepine, rifampin, etc.) may also enhance clearance of SN-38, which may possibly decrease efficacy; therefore, concomitant administration of these drugs should be avoided; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (23 Sites)
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Stanford Cancer Institute Palo Alto — Palo Alto, California
- Keck Medical Center of USC Pasadena — Pasadena, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- UCSF Medical Center-Mount Zion — San Francisco, California
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Wayne State University/Karmanos Cancer Institute — Detroit, Michigan
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center-South County — St Louis, Missouri
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.