Interim phase 1 data show CTIM-76 achieved a 29% confirmed overall response rate in heavily pretreated patients with platinum-resistant ovarian cancer, while demonstrating a favorable safety profile and low rates of cytokine release syndrome.
Context Therapeutics has reported positive interim results from its ongoing phase 1 study evaluating CTIM-76, a CLDN6 x CD3 T-cell-engaging bispecific antibody, in patients with advanced platinum-resistant ovarian cancer (PROC). The findings demonstrated encouraging anti-tumor activity and a manageable safety profile in a heavily pretreated patient population with limited treatment options.¹
The data, based on a May 29, 2026 cutoff, were presented from the dose-escalation portion of the trial. Among seven efficacy-evaluable PROC patients treated at active dose levels ranging from 140 µg to 280 µg, CTIM-76 achieved a confirmed overall response rate (ORR) of 29%, with two patients experiencing partial responses according to RECIST v1.1 criteria. The disease control rate reached 57%, with four of seven patients achieving either stable disease or a partial response.¹
“We are encouraged by the continued development of CTIM-76 as a potentially best-in-class CLDN6 T cell engager that may offer a much-needed new therapeutic approach for patients with platinum-resistant ovarian cancer,” said Martin Lehr, chief executive officer of Context Therapeutics.¹
The ovarian cancer patients enrolled in the study represented a particularly challenging treatment population. Participants had received a median of seven prior lines of therapy, with many previously exposed to antibody-drug conjugates, immune checkpoint inhibitors, anti-VEGF therapies, and DNA repair-targeted treatments. Additionally, 44% had liver metastases at enrollment.¹
CTIM-76 targets Claudin 6 (CLDN6), an oncofetal antigen expressed across multiple solid tumors, including ovarian, endometrial, gastric, lung, and testicular cancers. The bispecific antibody is designed to redirect T cells to tumor cells expressing CLDN6, promoting targeted immune-mediated cell killing.²
Safety findings were favorable and consistent with the expected mechanism of action for T-cell-engaging therapies. Most adverse events occurred during the first or second dose and were Grade 1 or Grade 2 in severity. Notably, cytokine release syndrome (CRS), a common concern with T-cell-engaging therapies, was reported in only one patient with PROC and was limited to Grade 1 severity.¹
“We are encouraged by the continued development of CTIM-76 as a potentially best-in-class CLDN6 T cell engager that may offer a much-needed new therapeutic approach for patients with platinum-resistant ovarian cancer.”
— Martin Lehr, Chief Executive Officer, Context Therapeutics
Pharmacokinetic analyses showed higher CTIM-76 exposure at increasing dose levels, supporting further evaluation of an every-three-week dosing schedule. Context Therapeutics plans to begin exploring the Q3W regimen during the second half of 2026, with findings expected to inform phase 1b dose-expansion studies planned for 2027.¹
The therapy has received Fast Track designation from the FDA for platinum-resistant ovarian cancer, highlighting the significant unmet need in this patient population. Despite advances in targeted therapies and antibody-drug conjugates, outcomes remain poor for patients whose disease progresses following platinum-based treatment.³
The ongoing phase 1 trial (NCT06515613) continues to evaluate CTIM-76 across multiple CLDN6-positive solid tumors, including ovarian, testicular, and endometrial cancers.²
