Context Therapeutics Inc. (NASDAQ:CNTX) on Monday released interim Phase 1 data for CTIM-76, its CLDN6 x CD3 T-cell engaging bispecific antibody, showing early signs of efficacy and a favorable safety profile in patients with advanced, late-line platinum-resistant ovarian cancer.
The data, based on a May 29, 2026, cutoff from the ongoing Phase 1 study, included 21 patients across ovarian, testicular, and endometrial cancers who received weekly doses ranging from 22.5 micrograms to 560 micrograms.
The biopharmaceutical company focused on advancing T cell-engaging bispecific antibodies for solid tumors.
Responses Observed At Active Dose Levels
Among patients treated at active dose levels of 140 micrograms to 280 micrograms, 13 patients received CTIM-76, and 10 were evaluable for efficacy after at least one post-baseline tumor assessment.
Seven platinum-resistant ovarian cancer patients were efficacy-evaluable at these dose levels. Two patients achieved confirmed partial responses, resulting in an overall response rate of 29%.
The disease control rate reached 57%, with four of seven patients achieving either stable disease or a partial response.
Context Therapeutics said three early-cohort patients who achieved stable disease or better maintained treatment benefit for at least six months.
The company noted that the 560-microgram dose exceeded target exposure levels with weekly dosing and was not advanced further in development.
Safety Profile Supports Continued Development
According to the interim analysis, CTIM-76 demonstrated a safety profile consistent with the expected mechanism of action of T-cell engagers.
Most treatment-related adverse events occurred during the first or second dose and were predominantly Grade 1 or Grade 2 in severity.
The events were generally reversible with standard management.
Cytokine release syndrome events were infrequent among platinum-resistant ovarian cancer patients treated at active dose levels. One of nine patients experienced a Grade 1 event, with no higher-grade CRS reported.
Pharmacokinetic Findings Suggest Dosing Flexibility
Pharmacokinetic analyses showed approximately dose-dependent increases in CTIM-76 exposure as dose levels increased.
The company said preliminary pharmacokinetic data support evaluating a dosing schedule of once every three weeks in future studies.
CNTX Price Action: Context Therapeutics shares were down 50.22% at $0.69 at the time of publication on Monday. The stock is near its 52-week low of $0.56, according to Benzinga Pro data.
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