Clinical trial NCT06515613: A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Platinum-resistant Ovarian Cancer
Testicular Cancer
Endometrial Cancer
Lead sponsor: Context Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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

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 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.

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.

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: From date of first dose of CTIM-76 until 28 days following the first dose
measure: Overall response rate (ORR)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Context Investigational Site
state: Arkansas
city: Hackensack
country: United States
facility: Context Investigational Site
state: New Jersey
city: New York City
country: United States
facility: Context Investigational Site
state: New York
city: Canton
country: United States
facility: Context Investigational Site
state: Ohio
city: Portland
country: United States
facility: Context Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Context Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Context Investigational Site
state: Rhode Island
city: Dallas
country: United States
facility: Context Investigational Site
state: Texas
Study officials:
affiliation: Context Therapeutics Inc.
name: Karen Smith, MD, PhD, MBA, LLM
role: STUDY_CHAIR
References: