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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Context Therapeutics Inc.
Study ID
NCT06515613
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CTIM-76 — DRUG
    CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.

Study Details

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).

Key Dates

Start date
Jul 10, 2024
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
156 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: From date of first dose of CTIM-76 until 28 days following the first dose ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of Arkansas Winthrop P. Rockefeller Cancer InstituteLittle RockArkansas72205
Maroof Zafar
[email protected]
501-686-8274
Precision NextGen Oncology & Research CenterBeverly HillsCalifornia90212-
SCRI at Denver HealthDenverColorado80218
Front Desk
[email protected]
720-754-2610
Dana-Farber Cancer InstituteBostonMassachusetts02215
Rebecca Porter, MD
[email protected]
(877) 338-7425
John Theurer Cancer CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Roisin O'Cearbhaill, MD
[email protected]
Duke Cancer InstituteDurhamNorth Carolina27710
Duke Cancer Institute - Phase I and Immunotherapy Trials
[email protected]
919-684-6342
Gabrail Cancer CenterCantonOhio44718-
Providence Cancer Institute of OregonPortlandOregon97213
Christopher Darus, MD
[email protected]
503-215-2075
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Women & Infants Hospital of Rhode IslandProvidenceRhode Island02905
Mary Dionne
[email protected]
401-453-8181
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
[email protected]
800-811-8480
SCRI at Mary CrowleyDallasTexas75230
Angela Hotchkiss
[email protected]
214-658-1958

Find similar trials in Little Rock, AR

By condition
Endometrial cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arkansas Winthrop P. Rockefeller Cancer Institute· Little Rock, ARPrecision NextGen Oncology & Research Center· Beverly Hills, CASCRI at Denver Health· Denver, CODana-Farber Cancer Institute· Boston, MAJohn Theurer Cancer Center· Hackensack, NJMemorial Sloan Kettering Cancer Center· New York, NY

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