A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
NCT ID: NCT06515613
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2024-07-10
2028-04-30
Brief Summary
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Detailed Description
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The phase 1b dose expansion phase will evaluate CTIM-76 in at least one indication at up to 2 doses and/or dosing schedules (n=20 response evaluable participants in each cohort ) in the dose expansion phase of the trial (Phase 1b) studying one of the following advanced solid tumor types: PROC, testicular, or endometrial. This is to enable dose- and exposure-response analyses. The expansion doses/dosing schedules 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 RP2D will be based on the totality of data from Phase 1b.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CTIM-76
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
CTIM-76
CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Interventions
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CTIM-76
CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with measurable disease per RECIST 1.1.
* ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
* Participants with adequate organ function.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Context Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Chagin, MD
Role: STUDY_CHAIR
Context Therapeutics Inc.
Locations
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University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States
SCRI at Denver Health
Denver, Colorado, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Providence Cancer Institute of Oregon
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
SCRI at Mary Crowley
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
Role: primary
Other Identifiers
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CNTX-CTIM76-101
Identifier Type: -
Identifier Source: org_study_id
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