Active — Not RecruitingPhase 1

M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)

United States, Australia, Japan60 participantsStarted 2024-08-07

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Module 1 Part A1 and Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT06421935

SponsorEMD Serono Research & Development Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-22

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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.

What they're measuring

Module 1 Part A1 and Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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

Timeframe: 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