RecruitingNCT06515613ClinicalTrials.gov record

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

Platinum-resistant Ovarian Cancer · Testicular Cancer · Endometrial Cancer

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 1
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 156 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Read the full description

The phase 1a dose escalation portion of the trial will enroll participants with 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 according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision.

The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

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.

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

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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

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 - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76

Drug: CTIM-76

CTIM-76 DRUG

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

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What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Incidence of Dose Limiting Toxicities (DLTs)

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

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

Overall response rate (ORR)

Time frame: 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

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (16)

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Find a location in this study

16 locations

University of Arkansas Winthrop P. Rockefeller Cancer InstituteLittle Rock, Arkansas, United StatesRecruiting