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Evaluating M9466 for advanced solid tumors

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors

PHASE1 · EMD Serono · NCT06421935

This study is testing a new treatment called M9466, alone and with other drugs, to see if it can help people with advanced solid tumors feel better and improve their condition.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years and up
SexAll
SponsorEMD Serono (industry)
Drugs / interventionschemotherapy, prednisone
Locations18 sites (New York, New York and 17 other locations)
Trial IDNCT06421935 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of M9466, both alone and in combination with tuvusertib or an androgen receptor pathway inhibitor (ARPi), in patients with advanced solid tumors. Participants will receive treatment until disease progression or other specified endpoints, with frequent monitoring during the initial cycles. The study will also explore early signs of clinical activity of M9466 in combination with tuvusertib.

Who should consider this trial

Good fit: Ideal candidates include individuals with locally advanced or metastatic solid tumors that are refractory to standard therapy, particularly those with metastatic castration-resistant prostate cancer.

Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: Other studies involving PARP inhibitors and combination therapies have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Module 1 Part A1 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
* 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 malignancy within 5 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/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

Where this trial is running

New York, New York and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor, PARP inhibitor, castration-resistant prostate cancer, ovarian cancer, Abiraterone Acetate

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.