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Advanced Solid TumorsPhase 1NCT06719973

Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

A Phase 1 study testing M9466, Carboplatin and Etoposide in people with Advanced Solid Tumors, run by EMD Serono Research & Development Institute, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
M9466, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
14 May 2025to 14 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

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: Locally advanced or metastatic solid tumors that are 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 options according to International Guidelines), which may convey clinical benefit from the combination treatment with M9466 and carboplatin and have not received more than 3 lines of prior anticancer therapy in the advanced/metastatic setting Module 2: Histologically or cytologically confirmed treatment-naïve, de novo, extensive stage small cell lung cancer (ES-SCLC), who have no history of systemic treatment for the disease. Participant must be considered suitable to receive carboplatin, etoposide, and atezolizumab as first-line treatment for ES-SCLC
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (<=) 1 (ECOG PS 2 eligible if considered related to SCLC tumor load in Module 2)
  • Have adequate hematological, hepatic, and renal function as defined in the protocol
  • Other protocol defined inclusion criteria could apply

Who cannot join

  • Module 1: 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 (NCI-CTCAE) v5.0 unless AEs are clinically non-significant and /or stable on supportive therapy in the opinion of the Investigator (for example [e.g.] neuropathy or alopecia)
  • Module 2: Participant has a history of 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/hypertropia, or malignancy that in the opinion of the Investigator, 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 CNS tumors that are asymptomatic and who do not require steroids for the treatment of CNS tumors
  • Life expectancy of less than (<) 3 months
  • Other protocol defined exclusion criteria could apply

About this study

Official title: An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.

Being tested
M9466, Carboplatin, Etoposide, Atezolizumab, M9446
Keywords
PARP inhibitor, DNA damage repair inhibitor, etoposide, atezolizumab, SCLC

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 receive an escalating doses of M9466 orally in 21-day cycles until disease progression, intolerable toxicity, death, withdrawal of study or study consent, lost to follow-up, or end of study.

  • CarboplatinDrug

    Carboplatin will be administered intravenously on Day 1 of each 21-day cycle.

  • EtoposideDrug

    Etoposide will be administered intravenously as per standard of care.

  • AtezolizumabDrug

    Atezolizumab will be administered intravenously as per standard of care.

  • M9446Drug

    Also called HRS-1167

    M9446 dose will be further investigated in Module 2 Part A of the study.

  • M9446Drug

    Also called HRS-1167

    M9446 recommended Dose for Expansion (RDE) will be further investigated in Module 2 Part B of the study.

  • CarboplatinDrug

    Carboplatin will be administered intravenously as per standard of care.

Study groups in NCT06719973
Study groupRoleWhat they receive
Module 1 (Dose Finding): M9466 + CarboplatinExperimentalNot described
Receives: Drug: M9466; Drug: Carboplatin
Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + AtezolizumabExperimentalNot described
Receives: Drug: Etoposide; Drug: Atezolizumab; Drug: M9446; Drug: Carboplatin
Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + AtezolizumabExperimentalNot described
Receives: Drug: Etoposide; Drug: Atezolizumab; Drug: M9446; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Module 1 and Module 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs

    Measured: Time from signing Informed Consent Form (ICF) up to 30 days after end of study intervention (approximately assessed up to 24 months)

  2. Module 1 and Module 2: Number of Participants with Dose-limiting Toxicity (DLT)

    Measured: Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)

Secondary outcomes (4)

  1. Module 1 and Module 2: Pharmacokinetic (PK) Plasma Concentration of M9466

    Measured: Pre-dose up to 6 hours post-dose on Cycle 1 Day 1; Pre-dose on Cycle 1 Day 4 and Cycle 1 Day 8 (each cycle is of 21 days)

  2. Module 1 and Module 2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Assessed by Investigator

    Measured: Time from first treatment of study intervention up to planned assessment at 24 months

  3. Module 1 and Module 2: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by the Investigator

    Measured: Time from first treatment of study intervention up to planned assessment at 24 months

  4. Module 1 and Module 2: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator

    Measured: Time from first treatment of study intervention up to planned assessment at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start14 May 2025
  3. Primary completion14 May 2025
  4. Study completion14 May 2025

Why it stopped: Study was terminated due to decision made not to proceed with the clinical trial DDRiver 521, that has not yet commenced enrolment, for strategic reasons.

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719973
Sponsor's protocol ID
MS202650_0009
Other IDs
2024-514921-45-00
Status last verified
Jun 2025
First submitted
2 Dec 2024
Last updated
17 Jun 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing M9466, Carboplatin and Etoposide in people with Advanced Solid Tumors, run by EMD Serono Research & Development Institute, Inc..

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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 and Module 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs (time frame: Time from signing Informed Consent Form (ICF) up to 30 days after end of study intervention (approximately assessed up to 24 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06719973.

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 17 Jun 2025.

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