Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTIM-76 · 1 trial · 3 indications
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| CTIM-76 | DRUG | CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression. |
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. ...
CTIM-76 is an investigational small molecule being developed for the treatment of platinum-resistant ovarian cancer. It is also being studied in testicular cancer and endometrial cancer. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
CTIM-76 targets CLDN6, a protein that is overexpressed in certain solid tumors. By targeting CLDN6, the drug aims to interfere with cancer cell growth and survival. This mechanism is being evaluated in a Phase 1 clinical trial for patients with recurring ovarian cancer and other advanced solid tumors.
CTIM-76 is being developed by Context Therapeutics Inc., a biopharmaceutical company. The company is publicly traded on the NASDAQ under the ticker symbol CNTX. Context Therapeutics is conducting clinical trials to evaluate the safety and efficacy of CTIM-76 in patients with advanced solid tumors.
CTIM-76 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug has received Fast Track designation from the FDA, which may expedite its development and review process.
CTIM-76 is being studied in a Phase 1 clinical trial with the identifier NCT06515613. This trial is recruiting patients with platinum-resistant ovarian cancer, testicular cancer, and endometrial cancer. The study is being conducted in the United States and the United Kingdom, with a planned enrollment of 156 participants.
CTIM-76 is a unique investigational drug and is not known to be the same as any other approved or investigational medication. It is a small molecule that specifically targets the CLDN6 protein, which distinguishes it from other cancer therapies. No alternative names for CTIM-76 have been reported.