NCT06515613

Brief 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 CLDN6-directed T cell-engaging bispecific antibody, in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
24mo left

Started Jul 2024

Typical duration for phase_1

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2024Apr 2028

Study Start

First participant enrolled

July 10, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

April 13, 2026

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

July 16, 2024

Last Update Submit

April 9, 2026

Conditions

Testicular CancerEndometrial CancerPlatinum-resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of Dose Limiting Toxicities (DLTs)

    Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs

    From date of first dose of CTIM-76 until 28 days following the first dose

  • Overall response rate (ORR)

    ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1

    From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (1)

CTIM-76

EXPERIMENTAL

Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts. Phase 1b: Dose Expansion - 40 subjects will be evaluated using 2 different doses/dosing schedules of CTIM-76

Drug: CTIM-76

Interventions

CTIM-76DRUG

CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.

Also known as: CTIM-76 Claudin 6 bispecific Antibody
CTIM-76

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
  • Participants with measurable disease per RECIST 1.1.
  • ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
  • Participants with adequate organ function.

You may not qualify if:

  • 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 participant's participation in the study.
  • Concurrent participation in another investigational clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Arkansas Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, 72205, United States

RECRUITING

Precision NextGen Oncology & Research Center

Beverly Hills, California, 90212, United States

WITHDRAWN

SCRI at Denver Health

Denver, Colorado, 80218, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

TERMINATED

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Gabrail Cancer Center

Canton, Ohio, 44718, United States

WITHDRAWN

Providence Cancer Institute of Oregon

Portland, Oregon, 97213, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

WITHDRAWN

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

SCRI at Mary Crowley

Dallas, Texas, 75230, United States

RECRUITING

MeSH Terms

Conditions

Testicular NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersUterine NeoplasmsGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Karen Chagin, MD

    Context Therapeutics Inc.

    STUDY CHAIR

Central Study Contacts

MaryBeth LeRose

CONTACT

267-225-7416clinical@contexttherapeutics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will evaluate 2 doses from the phase 1a.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 23, 2024

Study Start

July 10, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

April 13, 2026

Record last verified: 2025-12

Locations

US(13)