The FDA has granted a fast track designation to CTIM-76, a claudin 6 (CLDN6) x CD3 T-cell–engaging bispecific antibody, for the treatment of patients with platinum-resistant ovarian cancer following all standard-of-care treatment.1
The agent is under evaluation in a first-in-human phase 1 trial (NCT06515613) in patients with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancers. The dose-escalation and dose-expansion phases of the trial will assess safety, tolerability, and pharmacokinetics, as well as antitumor activity according to overall response rate (ORR), duration of response, and disease control rate.2
“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,” Karen Chagin, MD, chief medical officer of Context Therapeutics, said in a news 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.”
US Regulatory Agency Expedites Review Time for CTIM-76 in PROC
- CTIM-76, a novel bispecific antibody targeting CLDN6 and CD3, has received FDA fast track designation for patients with platinum-resistant ovarian cancer who have exhausted standard treatments.
- A phase 1 study is evaluating safety, dosing, and early effectiveness across ovarian, endometrial, and testicular cancer, with key measures including response rate and treatment tolerability.
- CLDN6 is widely expressed in multiple solid tumors, suggesting CTIM-76 could have applications beyond ovarian cancer if clinical results are positive.
Is CLDN6 commonly expressed in solid tumors?
CLDN6 is commonly expressed in many solid tumors, including ovarian, endometrial, lung, gastric, and testicular cancer, with very limited expression in normal adult tissues.1,3 CLDN6 represents an attractive target because of its high target antigen density and slow rate of internalization.3 CTIM-76 was designed to bind with high selectivity to CLDN6 and redirect the immune system’s T cells to spot and eliminate CLDN6-expressing cells.
In xenograft models of ovarian cancer, CTIM-76 inhibited tumor growth and demonstrated complete responses. Additionally, preclinical research supports the potential widespread manufacturing and adoption of therapy with CTIM-76.1
What are the trial’s design and objectives?
In the dose-escalation phase, which will include 9 dose cohorts, patients will receive CTIM-76 on days 1, 8, 15, and 22 of every 28-day cycle until disease progression.2 Toxicity will be evaluated 28 days after the first treatment dose. The first 2 dose levels will enroll 1 patient each at a starting dose of 22.5 µg, with step dosing and steroid premedication to reduce the potential for cytokine release syndrome.3
In the dose-expansion phase, 2 different doses and schedules of CTIM-76 will be evaluated in approximately 40 patients.2
The primary end points are the incidence of dose-limiting toxicities and ORR.
To be eligible, patients must have received a diagnosis of CLDN6-positive platinum-resistant or refractory ovarian, advanced testicular, or advanced endometrial cancer. They also had to have measurable disease per RECIST 1.1 criteria, an ECOG performance status of 0 to 2, a life expectancy of at least 12 weeks, and adequate organ function.
Patients were excluded from enrollment if they had evidence of central nervous system metastases, leptomeningeal disease, or spinal cord compression; uncontrolled, significant active infection; other medical conditions that would prevent their participation in the study; or concurrent participation in another clinical trial.
References
- 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 2, 2026. https://ir.contexttherapeutics.com/news-releases/news-release-details/context-therapeutics-announces-ctim-76-receives-fda-fast-track
- 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 2, 2026. https://clinicaltrials.gov/study/NCT06515613
- O’Cearbhaill RE, Barve MA, Darus C, et al. A phase 1, first-in-human study of CTIM-76, a claudin-6 (CLDN6)-directed bispecific antibody, in patients with recurrent ovarian cancer and other advanced solid tumors. J Clin Oncol. 2025;43(suppl 16):TPS2685. doi:10.1200/JCO.2025.43.16_suppl.TPS2685
