A Trial of Varsetatug Masetecan in Combination With Anti-Cancer Therapies in Participants With Metastatic Colorectal Cancer

Study Identifier:
CTMX-2051-201
CT.gov Identifier:
NCT07900165
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

This is a non-registrational Phase 1/2, multicenter, open-label trial to evaluate the efficacy and safety of varsetatug masetecan combined with anti-cancer therapies in participants with unresectable metastatic colorectal cancer in the second line treatment setting.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: varsetatug masetecan + bevacizumab + 5-FU + leucovorin
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Drug: Drug: bevacizumab + 5-FU + leucovorin
Drug: IV infusion
Drug: Drug: varsetatug masetecan
Drug: Investigational Product
Drug: EXPERIMENTAL: varsetatug masetecan + bevacizumab
Drug: Drug: bevacizumab
Drug: Other Names: Avastin
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • * Histologically or cytologically documented unresectable metastatic CRC
  • * Documented progression during or following exactly one prior regimen of systemic therapy with or without targeted therapy for metastatic CRC
  • * Measurable disease per RECIST v1.1
  • * Eastern Cooperative Oncology Group performance status of 0-1
  • * Adequate organ and marrow function
  • * Additional inclusion criteria may apply
Exclusion criteria
  • Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
  • * Participants with prior CNS involvement with malignancy must have completed effective treatment of their CNS disease at least 4 weeks prior to first dose of trial intervention
  • * Serious concurrent illness
  • * Clinically significant proteinuria
  • * Prior treatment with ADCs with Topo-I inhibitor payload
  • * Prior treatment with irinotecan or Topo-I inhibitors
  • * Receipt of systemic anti-cancer treatment, radiotherapy, or investigational agent(s) within 14days prior to trial intervention initiation
  • * Pregnant or breastfeeding
  • * Surgery within 4 weeks prior to first dose of trial intervention
  • * Additional exclusion criteria may apply

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site