A Phase I, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: I
Principal Investigator: Moore, Kathleen
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06515613?term=NCT06515613&viewType=Card&rank=1&tab=study#participation-criteria
Summary
Phase 1a, Dose Escalation
Primary:
- To characterize the safety and tolerability of CTIM-76 in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (testicular and endometrial).
- To establish the recommended doses for expansion (RDEs) of CTIM-76.
Secondary:
- To characterize the PK profile of CTIM-76.
- To evaluate the immunogenicity of CTIM-76.
- To evaluate preliminary efficacy of CTIM-76 as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- To evaluate the efficacy of CTIM-76 as per Immune RECIST (iRECIST).
Exploratory:
- Assess changes in pro-inflammatory biomarkers.
- Evaluate the PD effect of CTIM-76 monotherapy in modulating the immune system in blood.
- Assess changes within the tumor and microenvironment.
Phase 1b, Dose Expansion
Primary:
- To evaluate preliminary efficacy of CTIM-76 in participants with PRROC and other advanced CLDN6-positive solid tumors (testicular and endometrial).
- To further evaluate the safety of CTIM-76.
- To establish the recommended Phase 2 dose of CTIM-76 in participants with PRROC and other advanced CLDN6-positive solid tumors (testicular and endometrial).
Secondary:
- To characterize the PK profile of CTIM-76.
- To evaluate the immunogenicity of CTIM-76.
- To evaluate efficacy of CTIM-76 as per RECIST v1.1.
- To evaluate the efficacy of CTIM-76 as per iRECIST.
Exploratory:
- To evaluate the relationship between CLDN6 expression levels and response to CTIM-76.
- Assess changes in pro-inflammatory serum biomarkers.
- Evaluate the PD effect of CTIM-76 monotherapy in modulating the immune system in blood.
- Assess changes within the tumor and microenvironment.