A Phase 1 Study of CTIM-76 in Patients with Recurring Ovarian Cancer and Other Advanced Solid Tumors

Description

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).

Conditions

Platinum-resistant Ovarian Cancer, Testicular Cancer, Endometrial Cancer

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Study Overview

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Study Details

Study overview

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).

A Phase 1, 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

A Phase 1 Study of CTIM-76 in Patients with Recurring Ovarian Cancer and Other Advanced Solid Tumors

Condition
Platinum-resistant Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Context Investigational Site, Beverly Hills, California, United States, 90212

New York City

Context Investigational Site, New York City, New York, United States, 10021

Canton

Context Investigational Site, Canton, Ohio, United States, 44718

Dallas

Context Investigational Site, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Context Therapeutics Inc.,

Claudio Dansky Ullmann, MD, STUDY_CHAIR, Context Therapeutics Inc.

Study Record Dates

2028-03-31