New drug combo targets Hard-to-Treat cancers in early trial
NCT ID NCT06421935
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This early-phase study tests a new drug called M9466, a PARP1 inhibitor, alone or combined with other drugs in 60 people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety and how the body processes the drug. Researchers will also look for any signs that the tumors shrink.
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), tuvusertib, abiraterone acetate, prednisone/prednisolone
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early Phase 1 trial with only 60 participants, so it is too soon to know if the drug works. The main goal is safety, and side effects are possible.
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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60 people
The number who actually took part.
- Started
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Aug 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- 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: * Module 1 Part A and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator * Module 1 Part A2: Histologically or pathologically confirmed advanced or metastatic CRPC or EOC * Eastern Cooperative Oncology Group Performance Status less than or equal to (\<=) 1 * Life expectancy of more than 6 months * Have adequate hematologic function * Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (± tuvusertib) * Module 3 Part A1: * Histologically or pathologically confirmed diagnosis of prostate cancer * Metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI * Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) are allowed. For mCRPC, serum testosterone levels ≤ 50 /dL (≤ 1.75 nmol/L). * Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before first dose and must continue throughout the study. * Candidate for treatment with ·abiraterone acetate. * Prior anticancer therapy allowed for mHSPC or mCRPC * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia) * Participant has a history of additional malignancy within 5 years before the date of enrollment other than disease under study (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years) * Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days * Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications * Cerebrovascular accident or stroke * Module 3 only: * Current evidence of any of the following: 1. Any medical condition that would make prednisone (or equivalent) use contraindicated. 2. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone (or equivalent) once daily. * History of uncontrolled pituitary or adrenal dysfunction * Hypokalemia * 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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Asan Medical Center
Seoul, South Korea
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Cancer Institute Hospital of JFCR
Kōtoku, Japan
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Cancer Research SA
Adelaide, Australia
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Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid, Spain
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GenesisCare North Shore (Oncology)
St Leonards, Australia
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Harasanshin Hospital
Fukuoka, Japan
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Hospital HM Nou Delfos - START Barcelona
Barcelona, Spain
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Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, Spain
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Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid, Spain
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Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid, Spain
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ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
Barcelona, Spain
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NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain
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NEXT Oncology - PARENT
New York, New York, 10065, United States
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NHO Kumamoto Medical Center - Dept of Urology
Kumamoto, Japan
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National Cancer Center Hospital East - Dept of Experimental Therapeutics
Kashiwa-shi, Japan
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Samsung Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Seongnam, South Korea
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Seoul National University Hospital
Seoul, South Korea
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Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul, South Korea
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer