Advanced Solid TumorPhase 1NCT06421935
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
A Phase 1 study testing M9466, Tuvusertib and Abiraterone acetate in people with Advanced Solid Tumor, run by EMD Serono Research & Development Institute, Inc. at 20 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- M9466, Tuvusertib and Abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 7 Aug 2024to 22 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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:
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- Current evidence of any of the following:
- Any medical condition that would make prednisone (or equivalent) use contraindicated.
- 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
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Spain7 sites
Hospital HM Nou Delfos - START Barcelona
Barcelona
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
Barcelona
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul
Japan4 sites
Harasanshin Hospital
Fukuoka
National Cancer Center Hospital East - Dept of Experimental Therapeutics
Kashiwa-shi
Cancer Institute Hospital of JFCR
Kōtoku
NHO Kumamoto Medical Center - Dept of Urology
Kumamoto
United States2 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology - PARENT
New York, New York, 10065
Australia2 sites
Cancer Research SA
Adelaide
GenesisCare North Shore (Oncology)
St Leonards
About this study
Official title: 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
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
- Conditions
- Advanced Solid Tumor
- Being tested
- M9466, Tuvusertib, Abiraterone acetate, Prednisone/Prednisolone
- Keywords
- PARP inhibitor, castration-resistant Prostate cancer, ovarian cancer, Abiraterone Acetate
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M9466Drug
Also called HRS-1167;
Participants will be administered M9466 orally.
TuvusertibDrug
Also called Substance code MSC2584415A; also known as M1774, VXc-400, or VR 1363004
Participants will be administered Tuvusertib orally.
Abiraterone acetateDrug
Also called Abiraterone
Participants will be administered with Abiraterone acetate orally.
Prednisone/PrednisoloneDrug
Participants will be administered with prednisone/prednisolone orally.
| Study group | Role | What they receive |
|---|---|---|
| M9466 plus Tuvusertib | Experimental | Not described Receives: Drug: M9466; Drug: Tuvusertib |
| M9466 Monotherapy | Experimental | Not described Receives: Drug: M9466 |
| M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) | Experimental | Not described Receives: Drug: M9466; Drug: Abiraterone acetate; Drug: Prednisone/Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Module 1 Part A1 and Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)
Measured: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 1 Part A1 and Part A2: Number of Participants with Dose Limiting Toxicity (DLT)-like events
Measured: Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)
Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466
Measured: Cycle 1 Day 1 (C1D1), C1D8 and C1D15
Module 2 Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)
Measured: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 3 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs
Measured: Time from first treatment up to 30 days after end of study intervention
Module 3 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like Events
Measured: Day 1 up to Day 21 of Cycle 1(each cycle is of 21 days)
Secondary outcomes (5)
Module 1 Part A1 and Part A2, Module 2 Part A1 and A2 and Module 3 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib
Measured: Module 1 Part A1: C1D1 and C1D5 or C1D6; Module 1 Part A2: C1D1, C1D2, C1D3 or C1D4 and C1D8; Module 2 Part A1: C1D1, C1D8 and C1D15; Module 2 Part A2: C1D1, C1D2 and C1D8, C1D22 and C2D1; Module 2 Part A1: C1D1 and C1D8
Module 1 Part A1 and Part A2, Module 2 Part A2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or PCWG3 for prostate cancer) as Assessed by Investigator
Measured: Time from first treatment to planned assessment at 12 months
Module 1 Part A1 and Part A2; Module 2 Part A1 : Effect of M9466 in combination with tuvusertib on QTc interval as determined by Digital ECGs
Measured: Time from first treatment to planned assessment at 12 months
Module 2 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-Related AEs
Measured: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 2 Part A1 and Part A2: Relative Changes in Pharmacodynamics Markers in Paired Tumor Biopsies
Measured: Day 1, Day 8 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start7 Aug 2024
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Research & Development Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421935
- Sponsor's protocol ID
- MS202659_0001
- Other IDs
- 2024-513492-41-00, jRCT2031240255
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06421935
- Acronym / sponsor ID
- MS202659_0001
- Conditions
- Advanced Solid Tumor
- Keywords
- PARP inhibitor, castration-resistant Prostate cancer, ovarian cancer, Abiraterone Acetate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M9466 plus Tuvusertib | Experimental | Drug: M9466, Drug: Tuvusertib |
| M9466 Monotherapy | Experimental | Drug: M9466 |
| M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) | Experimental | Drug: M9466, Drug: Abiraterone acetate, Drug: Prednisone/Prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M9466Also: HRS-1167;Participants will be administered M9466 orally. | Drug | M9466 Monotherapy, M9466 plus Tuvusertib, M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) |
| TuvusertibAlso: Substance code MSC2584415A; also known as M1774, VXc-400, or VR 1363004Participants will be administered Tuvusertib orally. | Drug | M9466 plus Tuvusertib |
| Abiraterone acetateAlso: AbirateroneParticipants will be administered with Abiraterone acetate orally. | Drug | M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) |
| Prednisone/PrednisoloneParticipants will be administered with prednisone/prednisolone orally. | Drug | M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) |
Primary outcome
Module 1 Part A1 and Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)
Time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 1 Part A1 and Part A2: Number of Participants with Dose Limiting Toxicity (DLT)-like events
Time frame: Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)
Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466
Time frame: Cycle 1 Day 1 (C1D1), C1D8 and C1D15
Module 2 Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)
Time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 3 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs
Time frame: Time from first treatment up to 30 days after end of study intervention
Module 3 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like Events
Time frame: Day 1 up to Day 21 of Cycle 1(each cycle is of 21 days)
5 secondary outcomes
Module 1 Part A1 and Part A2, Module 2 Part A1 and A2 and Module 3 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib
Time frame: Module 1 Part A1: C1D1 and C1D5 or C1D6; Module 1 Part A2: C1D1, C1D2, C1D3 or C1D4 and C1D8; Module 2 Part A1: C1D1, C1D8 and C1D15; Module 2 Part A2: C1D1, C1D2 and C1D8, C1D22 and C2D1; Module 2 Part A1: C1D1 and C1D8
Module 1 Part A1 and Part A2, Module 2 Part A2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or PCWG3 for prostate cancer) as Assessed by Investigator
Time frame: Time from first treatment to planned assessment at 12 months
Module 1 Part A1 and Part A2; Module 2 Part A1 : Effect of M9466 in combination with tuvusertib on QTc interval as determined by Digital ECGs
Time frame: Time from first treatment to planned assessment at 12 months
Module 2 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-Related AEs
Time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 2 Part A1 and Part A2: Relative Changes in Pharmacodynamics Markers in Paired Tumor Biopsies
Time frame: Day 1, Day 8 and Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono Research & Development Institute, Inc.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M9466, Tuvusertib and Abiraterone acetate in people with Advanced Solid Tumor, run by EMD Serono Research & Development Institute, Inc. at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, South Korea, Japan, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Module 1 Part A1 and Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs) (time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.