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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTIM-76 | Drug | CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Context Clinical Development | Contact | 267-225-7416 | cntx-ctim76-101@contexttherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Karen Chagin, MD | Context Therapeutics Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas Winthrop P. Rockefeller Cancer Institute | Recruiting | Little Rock | Arkansas | 72205 | United States |
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Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will be evaluated in PRROC at a minimum of 2 dose levels and /or dosing schedules in the dose expansion phase of the trial (Phase 1b) to enable dose- and exposure-response analyses.
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| Precision NextGen Oncology & Research Center | Withdrawn | Beverly Hills | California | 90212 | United States |
| SCRI at Denver Health | Recruiting | Denver | Colorado | 80218 | United States |
|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| John Theurer Cancer Center | Terminated | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10021 | United States |
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| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710 | United States |
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| Gabrail Cancer Center | Withdrawn | Canton | Ohio | 44718 | United States |
| Providence Cancer Institute of Oregon | Recruiting | Portland | Oregon | 97213 | United States |
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| Fox Chase Cancer Center | Withdrawn | Philadelphia | Pennsylvania | 19111 | United States |
| Women & Infants Hospital of Rhode Island | Recruiting | Providence | Rhode Island | 02905 | United States |
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| Vanderbilt-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| SCRI at Mary Crowley | Recruiting | Dallas | Texas | 75230 | United States |
|
| University College London Hospital | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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