What this study is
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
What's being tested
- CBI-1214
Intervention · 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
- Official title
- A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer
- Sponsor
- Cartography Biosciences
- Conditions
- Colorectal Cancer · Colorectal Cancer (CRC) · Colorectal (Colon or Rectal) Cancer · CRC · Metastatic Colon Cancer · Colon Cancer · Advanced Colorectal Cancer
- Enrolling
- 80 people
- Starts
- 2026-01-15
- Est. completion
- 2029-10
- Design
- Open-label, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participant with MSS/MSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.
- Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must:; Have received prior treatment with applicable FDA-approved targeted therapies AND; Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy.
- Participant able to provide archival tissue sample or fresh biopsy tissue sample
You can't join if
- Participant whose CRC tumor tissues have been identified as dMMR or MSI-H
- Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis.
- Untreated central nervous system (CNS) metastatic disease.
- Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).
- History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.
- Known seropositive for human immunodeficiency virus, hepatitis B surface antigen, or antibody to hepatitis C virus with confirmatory testing and requiring anti-viral therapy.
- History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
- Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure >115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.
- Congenital long QT syndrome or a corrected QT interval (QTc) ≥480 ms at screening (unless secondary to pacemaker or bundle branch block).
- Active second primary malignancy within 3 years of Screening other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (10)
10 openMayo Clinic Arizona
Phoenix, Arizona, United States
- Clinical Trials Referral Office · Contact855-776-0015Cable.Sarah@mayo.edu
- Mojun Zhu, MD · Principal investigator
RecruitingCity of Hope Duarte
Duarte, California, United States
- Study Referral Coordinator · Contact800-826-4673jestebane@coh.org
- Marwan Fakih, MD · Principal investigator
RecruitingUCLA
Los Angeles, California, United States
- Rachel Andes · Contact855-731-6040randes@mednet.ucla.edu
- J. Randolph Hecht, MD · Principal investigator
RecruitingValkyrie Clinical Trials
Los Angeles, California, United States
- Myo Zaw · Contact424-565-1874myo.zaw@vctcare.com
- David Berz, MD, PhD, MPH · Principal investigator
RecruitingUCSF
San Francisco, California, United States
- UCSF Team · Contact415-353-2051HDFCCC.CIRCT@ucsf.edu
- David Oh, MD, PhD · Principal investigator
RecruitingMayo Clinic Florida
Jacksonville, Florida, United States
- Clinical Trials Referral Office · Contact855-776-0015Nussbaum.Samuel@mayo.edu
- Conor D O'Donnell, MB, BCh, BAO · Principal investigator
RecruitingEmory Winship Cancer Institute
Atlanta, Georgia, United States
- Study Referral Coordinator · Contact404-778-1900winship.referrals@emoryhealthcare.org
- Olatunji Alese, MD · Principal investigator
RecruitingSTART Midwest
Grand Rapids, Michigan, United States
- Julie Reish · Contact616-954-5554hopeteam@startresearch.com
- Manish Sharma, MD · Principal investigator
RecruitingNEXT Oncology
San Antonio, Texas, United States
- Jordan Georg · Contact(210) 580-9521jgeorg@nextoncology.com
- David Sommerhalder, MD · Principal investigator
RecruitingNEXT Oncology
Fairfax, Virginia, United States
- Maybelle De La Rosa · Contact(703) 783-4518mdelarosa@nextoncology.com
- Alexander Spira, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
Cartography Biosciences
Study ID CBI-1214-001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.