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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-14

Study Completion Date

2025-05-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Module 1 (Dose Finding): M9466 + Carboplatin

Group Type EXPERIMENTAL

M9466

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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

Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab

Group Type EXPERIMENTAL

Etoposide

Intervention Type DRUG

Etoposide will be administered intravenously as per standard of care.

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered intravenously as per standard of care.

M9446

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

Carboplatin will be administered intravenously as per standard of care.

Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab

Group Type EXPERIMENTAL

Etoposide

Intervention Type DRUG

Etoposide will be administered intravenously as per standard of care.

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered intravenously as per standard of care.

M9446

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

Carboplatin will be administered intravenously as per standard of care.

Interventions

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M9466

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.

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Etoposide

Etoposide will be administered intravenously as per standard of care.

Intervention Type DRUG

Atezolizumab

Atezolizumab will be administered intravenously as per standard of care.

Intervention Type DRUG

M9446

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

Intervention Type DRUG

M9446

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

Intervention Type DRUG

Carboplatin

Carboplatin will be administered intravenously as per standard of care.

Intervention Type DRUG

Other Intervention Names

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HRS-1167 HRS-1167 HRS-1167

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No