Experimental PARP inhibitor combo trial halted early after just 3 patients
NCT ID NCT06509906
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new drug called M9466 combined with standard chemotherapy in people with advanced solid tumors or colorectal cancer who had no other treatment options. Only 3 people took part before the study was stopped. The main goal was to check safety and find the right dose, but no conclusions can be drawn from such a small, terminated study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- M9466 (PARP1 inhibitor) combined with irinotecan, folinic acid, fluorouracil, and bevacizumab
- What this could lead to
- If successful, this could point toward a new combination treatment option for advanced solid tumors and colorectal cancer.
- What could go wrong
- This was a very early Phase 1 trial with only 3 participants and has been terminated, so results are extremely limited. The combination may cause significant side effects and may not work in larger groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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3 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * M9466 + Irinotecan Run-in Cohort: Participants with locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator (that is \[i.e.\] participants who have exhausted all standard of care (SoC) options according to International Guidelines), and who may derive clinical benefit from the combination treatment with M9466 and irinotecan * M9466 + FOLFIRI + Bevacizumab Dose Finding Cohorts: Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included: Oxaliplatin and a fluoropyrimidine (administration in the adjuvant setting fulfills this criterion if progression occurred within 12 months of the last dose). Prior use of irinotecan is permitted; Either an anti- epidermal growth factor receptor (anti-EGFR) or an anti- Vascular endothelial growth factor (anti-VEGF) agent (not applicable if oxaliplatin was administered in the adjuvant setting); An immune checkpoint inhibitor for participants with known MSI-H status; Anti-EGFR agent and BRAF tyrosine kinase inhibitor ± MEK inhibitor, if locally available, for participants with BRAF V600E mutations. Participants may have received maximally 1 previous regimen for the treatment of metastatic disease (with the exception of participants with MSI-H disease or BRAF positive disease who are allowed to have had up to 2 previous lines of treatment) * Eastern Cooperative Oncology Group performance status (ECOG PS) less than or equal to (\<=) 1 * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Persistence of AEs related to any prior treatments that have not recovered to Grade \<= 1 by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (for example \[e.g.\] neuropathy or alopecia) * History of additional malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertrophy, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years). Participants with history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) are excluded, irrespective of timeframe * Participant with known polymorphisms in UGT1A1, DPYD or other enzymes known to predict for increased toxicity from irinotecan or 5 fluorouracil (5-FU) should be excluded; if status is unknown testing is not mandated, unless required by local guidance. Participants that discontinued prior 5-FU treatment due to toxicity are also excluded * Participants with known brain metastases, except if clinically controlled, which is defined as individuals with central nervous system (CNS) tumors that have been treated and are asymptomatic, and who have discontinued steroids (for the treatment of CNS tumors) for \> 28 days prior to first dose of study intervention * Other protocol defined exclusion criteria could apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Research SA
Elizabeth Vale, Australia
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Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Pennington, New Jersey, 08534, United States
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NEXT Barcelona - NEXT Barcelona
Barcelona, Spain
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NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain
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National Cancer Center Hospital
Chūōku, Japan
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Peter MacCallum Cancer Centre - Use the one with Account 2 VCCC
Parkville, Australia
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Samsung Medical Center
Seoul, South Korea
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Sarah Cannon Research Institute at Health One
Denver, Colorado, 80218, United States
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Seoul National University Hospital
Seoul, South Korea
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St George Private Hospital
Kogarah, Australia
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
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Vanderbilt University - 150912667
Nashville, Tennessee, 37232, United States
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