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

Part of paid clinical trials in Denver, Colorado.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT06509906
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M9466 — DRUG
    M9466 will be administered orally until progressive disease, unacceptable toxicity, death, or end of study.
  • Irinotecan — DRUG
    Irinotecan will be administered intravenously once every 2 weeks (q2w) until progressive disease, unacceptable toxicity, death, or end of study.
  • Folinic acid — DRUG
    Folinic acid will be administered intravenously q2w as per standard of care.
  • Fluorouracil (5-FU) — DRUG
    Fluorouracil will be administered intravenously as per standard of care.
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously, q2w until progressive disease, unacceptable toxicity, death, or end of study.
  • Granulocyte colony stimulating factor (G-CSF) — DRUG
    G-CSF will be administered subcutaneously at every cycle of study intervention as per standard of care.

Study Details

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.

Key Dates

Start date
Oct 8, 2024
Status verified
Dec 2025
Primary completion
Dec 2, 2025
Completion
Dec 2, 2025

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: M9466 + Irinotecan (Run-in Cohort)
  • Experimental: M9466 + FOLFIRI (folinic acid, fluorouracil, irinotecan) + Bevacizumab (Dose Finding Cohorts)

Primary Outcome Measure

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 18.7 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at Health OneDenverColorado80218-
Carolina BioOncology Institute, LLC - Cancer Therapy and Research CenterPenningtonNew Jersey08534-
Vanderbilt University - 150912667NashvilleTennessee37232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute at Health One· Denver, COCarolina BioOncology Institute, LLC - Cancer Therapy and Research Center· Pennington, NJVanderbilt University - 150912667· Nashville, TNThe University of Texas MD Anderson Cancer Center· Houston, TX

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