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M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)

NCT06509906 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-12-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion.

Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die.

Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

M9466

M9466 will be administered orally until progressive disease, unacceptable toxicity, death, or end of study.

DRUG

Irinotecan

Irinotecan will be administered intravenously once every 2 weeks (q2w) until progressive disease, unacceptable toxicity, death, or end of study.

DRUG

Folinic acid

Folinic acid will be administered intravenously q2w as per standard of care.

DRUG

Fluorouracil (5-FU)

Fluorouracil will be administered intravenously as per standard of care.

DRUG

Bevacizumab

Bevacizumab will be administered intravenously, q2w until progressive disease, unacceptable toxicity, death, or end of study.

DRUG

Granulocyte colony stimulating factor (G-CSF)

G-CSF will be administered subcutaneously at every cycle of study intervention as per standard of care.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2025-12-02
Completion
2025-12-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509906 on ClinicalTrials.gov