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Trial Title:
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
NCT ID:
NCT06515613
Condition:
Platinum-resistant Ovarian Cancer
Testicular Cancer
Endometrial Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Testicular Neoplasms
Antibodies, Bispecific
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will
evaluate 2 doses from the phase 1a.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CTIM-76
Description:
Claudin 6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28 day
treatment cycle until disease progression.
Arm group label:
CTIM-76
Other name:
CTIM-76 Claudin 6 bispecific Antibody
Summary:
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the
safety and efficacy of CTIM-76 (study drug), a humanized T cell engaging bispecific
antibody targeting CLDN6, in subjects with platinum-refractory/resistant ovarian cancer
(PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and
endometrial).
Detailed description:
The phase 1a Dose Escalation portion of the trial will enroll subjects with
platinum-resistant/refractory ovarian cancer (PRROC), testicular, or endometrial cancer
into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to
determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once
weekly (Q1W) for each cycle. A cycle is defined as 28 days. Subjects will be dosed until
documentation of disease progression, unacceptable toxicity, or subject/physician
decision.
The phase 1b dose expansion phase will evaluate CTIM-76 in one indication (PRROC,
endometrial or testicular) at up to 2 doses (n=15 response evaluable subjects at each
dose level). This is to enable dose- and exposure-response analyses. Dosing will follow
the same schedule as Phase 1a. A priming dose will be administered on Day 1, and the full
cohort dose will be administered weekly thereafter. Expansion doses for Phase 1b will be
determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all
available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary
efficacy data from Phase 1a.
The selection of the recommended Phase 2 dose (RP2D) will be based on the totality of
data from Phase 1b.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced
testicular or advanced endometrial cancer.
- Subject with measurable disease per RECIST 1.1
- ECOG 0, 1, or 2
- Subjects with adequate organ function.
Exclusion Criteria:
- Evidence of central nervous system metastases, leptomeningeal disease or spinal cord
compression.
- Uncontrolled significant active infection or any medical or other condition that in
opinion of the investigator would preclude the subject's participation in the study.
- Prior treatment with CLDN-6 targeted therapy.
- Concurrent participation in another investigational clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Context Investigational Site
Address:
City:
Beverly Hills
Zip:
90212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brianna Heaviside
Phone:
424-777-0708
Facility:
Name:
Context Investigational Site
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kirstie Armstrong
Phone:
330-492-3345
Phone ext:
289
Email:
karmstrong@gabrailcancercenter.com
Facility:
Name:
Context Investigational Site
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Angela Hotchkiss
Phone:
214-658-1958
Email:
ahotchkiss@marycrowley.org
Start date:
July 10, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Context Therapeutics Inc.
Agency class:
Industry
Source:
Context Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06515613
