A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Cartography Biosciences
Study ID
NCT07321106
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • CBI-1214 — BIOLOGICAL
    CBI-1214 is a bispecific T cell engager that binds to LY6G6D and CD3. It is designed to link the patients T cells to cancer cells and to mediate tumor cell killing. LY6G6D is an emerging target specifically expressed on malignant colorectal cancer cells.

Study Details

This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer

Key Dates

Start date
Jan 15, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation and optimization trial of CBI-1214
    Participants will be assigned sequentially to escalating doses of CBI-1214. Once dose escalation is completed, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.

Primary Outcome Measure

To evaluate the safety and tolerability of CBI-1214 at increasing dose levels and optimized dose levels in participants with advanced or metastatic MSS/MSI-L CRC [ Time Frame: Approximately 48 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope DuarteDuarteCalifornia91010
Study Referral Coordinator
[email protected]
800-826-4673
Marwan Fakih, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Rachel Andes
[email protected]
855-731-6040
J. Randolph Hecht, MD (PRINCIPAL_INVESTIGATOR)
Valkyrie Clinical TrialsLos AngelesCalifornia91402
Myo Zaw
[email protected]
424-565-1874
David Berz, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR)
UCSFSan FranciscoCalifornia94158
Study Referral Coordinator
[email protected]
415-309-1810
David Oh, MD, PhD (PRINCIPAL_INVESTIGATOR)
Emory Winship Cancer InstituteAtlantaGeorgia30322
Study Referral Coordinator
[email protected]
404-778-1900
Olatunji Alese, MD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
Julie Reish
[email protected]
616-954-5554
Manish Sharma, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Jordan Georg
[email protected]
(210) 580-9521
David Sommerhalder, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologyFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
(703) 783-4518
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope Duarte· Duarte, CAUCLA· Los Angeles, CAValkyrie Clinical Trials· Los Angeles, CAUCSF· San Francisco, CAEmory Winship Cancer Institute· Atlanta, GASTART Midwest· Grand Rapids, MI

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