Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

Part of paid clinical trials in Encinitas, California.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT05464030
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • M9140 — DRUG
    M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Part 1 of the study.
  • M9140 — DRUG
    M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously as per standard of care.
  • Capecitabine — DRUG
    Capecitabine will be administered orally as per standard of care.
  • 5-fluorouracil (5-FU) — DRUG
    5-FU will be administered intravenously as per standard of care.
  • Folinic acid — DRUG
    Folinic acid will be administered intravenously as per standard of care.

Study Details

The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program

Key Dates

Start date
Aug 4, 2022
Status verified
May 2026
Primary completion
Oct 23, 2026
Completion
Oct 23, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: M9140
  • Experimental: Part 2A: M9140
  • Experimental: Part 2B: M9140
  • Experimental: Part 2C: M9140 + Bevacizumab +/-Capecitabine
  • Experimental: Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab

Primary Outcome Measure

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 4 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
California Cancer Associates for Research & Excellence, Inc.EncinitasCalifornia92024-
California Cancer Associates for Research & Excellence, Inc.FresnoCalifornia93720-
Rhode Island HospitalProvidenceRhode Island02903
Rimini Breakstone (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230
Minal Barve (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer Center - OncologyHoustonTexas77030
Kanwal Raghav (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Ismael Rodriguez (PRINCIPAL_INVESTIGATOR)

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