CTIM-76 Receives FDA Fast Track Status in Platinum-Resistant Ovarian Cancer

CTIM-76 has received fast track designation from the FDA for the treatment of patients with platinum-resistant ovarian cancer (PROC) who have received all standard-of-care therapies, according to a press release from the developer, Context Therapeutics.¹ CTIM-76 is a T-cell–engaging bispecific antibody that targets CLDN6, a protein highly expressed in various solid tumors but largely absent in healthy adult tissues.

Preclinical evidence previously demonstrated that CTIM-76 had potential for convenient dosing with low immunogenicity risk and scalable manufacturing. CTIM-76 was designed to overcome the challenges associated with targeting CLDN6, which shares high structural similarity with other claudin family members like CLDN9.² By utilizing a monovalent CD3-binding domain and a silenced Fc region, the agent may selectively activate T cells against CLDN6-expressing malignant cells while minimizing the risk of off-target toxicity and non-specific cytokine release.

“We are pleased to receive fast track designation for CTIM-76, which underscores its potential to improve the lives of patients with [PROC],” stated Karen Chagin, MD, chief medical officer of Context Therapeutics, in the press release.¹ “This designation is an important step forward in our goal to quickly and efficiently advance CTIM-76 through clinical development and we look forward to sharing interim data for this program in June 2026.”

What is the phase 1 trial evaluating CTIM-76 in PROC and other solid tumors?

The safety and efficacy of CTIM-76 are currently being evaluated as treatment for patients with PROC and other advanced CLDN6-positive solid tumors in an open-label, dose-escalation and dose-expansion phase 1a/b trial (NCT06515613).³ The trial is divided into a phase 1a dose-escalation portion and a phase 1b dose-expansion portion. Notably, interim data from the trial are expected to be shared in June 2026.

In the escalation portion, investigators are evaluating approximately 9 dose cohorts of patients with PROC, testicular cancer, or endometrial cancer to determine the recommended dose for expansion. The treatment regimen consists of CTIM-76 administered intravenously once weekly for 28-day cycles, with dosing to continue until documentation of disease progression, unacceptable toxicity, or patient/physician decision.

In the dose-expansion portion, CTIM-76 will be evaluated in at least 1 indication at up to 2 doses/dosing schedules with 20 response-evaluable patients in each cohort. Investigated tumor types in the dose-expansion portion are PROC, testicular cancer, and endometrial cancer. The trial sponsor will determine the expansion doses/dosing for phase 1b of the trial based on available safety, pharmacokinetic, pharmacodynamic, biomarker, and preliminary efficacy data from phase 1a. Then, the recommended phase 2 dose will be selected based on data collected from phase 1b.

Patient eligibility requires an age of 18 years or older and confirmed diagnosis of CLDN6-positive PROC, advanced testicular cancer, or advanced endometrial cancer. Patients must have measurable disease per RECIST v1.1 criteria, an ECOG performance status of 0 to 2, a life expectancy of at least 12 weeks, and adequate organ function. The study excludes patients with evidence of central nervous system metastases, leptomeningeal disease, or spinal cord compression, as well as uncontrolled active infections or any medical condition that would preclude the participant’s enrollment in the study. Approximately 80 patients are expected to be enrolled across both phases of the study.

The primary end point of the trial is the incidence of dose-limiting toxicities from the date of first dose until 28 days following the first dose in phase 1a, as well as overall response rate.

References

1. Context Therapeutics announces CTIM-76 receives FDA fast track designation for the treatment of platinum-resistant ovarian cancer. News release. Context Therapeutics Inc. April 2, 2026. Accessed April 3, 2026. https://tinyurl.com/3fhpztsd
2. CTIM-76: Claudin 6 x CD3 bispecific antibody. Context Therapeutics. Accessed April 3, 2026. https://tinyurl.com/bdduwzu6
3. A phase 1 study of CTIM-76 in patients with recurring ovarian cancer and other advanced solid tumors. ClinicalTrials.gov. Updated February 20, 2026. Accessed April 3, 2026. https://tinyurl.com/jjnbe7uv