CTIM-76 Receives FDA FTD for Platinum-Resistant Ovarian Cancer

The FDA has granted fast track designation to CTIM-76, an investigational therapy for patients with platinum-resistant ovarian cancer whose disease has progressed after all standard treatments, according to a press release from Context Therapeutics.1

The designation is intended to help speed the development and review of CTIM-76, which is currently being studied in a phase 1 clinical trial (NCT06515613).2 Patients with platinum-resistant ovarian cancer often have limited treatment options, making new therapies in this setting especially important.

“We are pleased to receive fast track designation for CTIM-76, which underscores its potential to improve the lives of patients with platinum-resistant ovarian cancer,” Dr. Karen Chagin, chief medical officer of Context, said in the press release. “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.”

Why this matters for patients

Ovarian cancer is commonly treated first with platinum-based chemotherapy. If the cancer returns within six months of treatment or does not respond to platinum therapy, it is considered platinum-resistant. In this setting, outcomes are typically less favorable and treatment choices are more limited.

CTIM-76 is designed to target a protein called CLDN6, which is found at higher levels in several solid tumors, including ovarian, endometrial, lung, gastric and testicular cancers. The treatment is a T-cell engaging bispecific antibody, meaning it is engineered to connect a patient’s immune cells, known as T cells, directly to cancer cells. The goal is to help the immune system recognize and attack the tumor.

Fast track designation from the FDA is granted to drugs that are intended to treat serious conditions and address unmet medical needs. While this designation does not mean CTIM-76 is approved, it may allow for more frequent communication with the FDA and potentially a faster review process if future data support approval.

Ongoing clinical trial and safety

CTIM-76 is currently being evaluated in a phase 1 clinical trial in patients with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers.

The primary end points of the trial included incidence of dose limiting toxicities and the overall response rate.

The phase 1a portion of the trial will be he dose escalation and enroll patients with platinum-resistant/recurrent ovarian cancer, testicular cancer, or endometrial cancer into one of nine dose escalation there, safety and tolerability will be determined for dose expansion.

CTIM-76 will be given once weekly for each 28-day cycle.

In the phase 1b expansion portion, CTIM-76 will be evaluated in at least 1 indication up to 2 doses and/or dosing scheduled, with 20 response evaluable patients in each cohort. The selection of the recommended phase 2 dose will be based off the phase 1b data.

Patients were eligible for the trial if they have CLDN6-positive platinum-resistant/refractory ovarian, advanced testicular or advanced endometrial cancer; had measurable disease per RECIST 1.1; had an ECOG performance status of 0 to 2, and a life expectancy of 12 weeks or more; and had adequate organ function.

Patients were excluded from treatment if they had central nervous system metastases, leptomeningeal disease, or spinal cord compression; uncontrolled significant active infection or any medical or other condition that could affect participation; or concurrent participation in another trial.

References

1. “CTIM-76 receives FDA fast track designation for the treatment of platinum resistant ovarian cancer”, news release, Context Therapeutics. April 2, 2026.

2. “A phase 1 study of CTIM-76 in patients with recurring ovarian cancer and other advanced solid tumors”, ClinicalTrials.gov. April 3, 2026.

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