Context Therapeutics Announces CTIM-76 Trial in Progress Poster Presentation at 2025 ASCO Meeting

Rhea-AI Summary

Context Therapeutics (NASDAQ: CNTX) announced a Trial in Progress poster presentation at the 2025 ASCO Annual Meeting for their Phase 1 clinical trial of CTIM-76, a Claudin 6 x CD3 T cell engager bispecific antibody. The trial, which began in January 2025, is evaluating CTIM-76's safety and efficacy in patients with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancers. Currently in cohort 3 with 7 active trial sites across the United States, the study aims to enroll up to 70 patients. The trial will assess safety, tolerability, pharmacokinetics, and anti-tumor activity metrics including overall response rate, duration of response, and disease control rate. Initial data from the trial is expected to be shared in the first half of 2026.

Insights

Oncology Clinical Trials Expert

Context Therapeutics advances Phase 1 trial of CTIM-76 cancer bispecific antibody to cohort 3, with initial data expected H1 2026.

Context Therapeutics' progression to the third dosing cohort in their Phase 1 trial of CTIM-76 represents steady advancement through the critical dose-escalation phase. This Claudin 6 x CD3 T cell engager is being evaluated in CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancers - all areas with significant unmet medical needs.

The company's ability to advance to cohort 3 suggests preliminary safety data from the first two cohorts was acceptable enough to proceed. In early-phase oncology trials, this progression is notable as it indicates no dose-limiting toxicities have halted the trial. T cell engagers like CTIM-76 often face challenges with cytokine release syndrome and neurotoxicity, so advancing through multiple dose cohorts is encouraging.

The trial's design appears robust with up to 70 patients planned across dose escalation and expansion phases. With 7 active U.S. trial sites, enrollment pace seems appropriate for this specialized cancer population. The expected data readout in first half of 2026 aligns with typical Phase 1 oncology timelines for a complex bispecific antibody.

The CLDN6 target is particularly interesting as it's highly tumor-specific with minimal expression in healthy adult tissues, potentially offering a wider therapeutic window than many cancer targets. However, investors should note that with initial data still approximately a year away, near-term catalysts are limited.

Dosing cohort 3 of Phase 1 trial of CTIM-76, a Claudin 6 x CD3 T cell engager

Expect to share initial data in the first half of 2026

PHILADELPHIA, June 02, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, announced today that it is presenting a Trial in Progress poster for the Phase 1 clinical trial evaluating CTIM-76 in ovarian, endometrial, and testicular cancers at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30 – June 3, 2025 in Chicago, IL.

The Phase 1 clinical trial is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity by overall response rate, duration of response, and disease control rate. The study is expected to enroll up to 70 patients.

CTIM-76 Highlights and Near-Term Milestones

• Dosed first patient in January 2025 and currently dosing cohort 3
• 7 active trial sites in the United States
• Expect to share initial data in the first half of 2026
  

Poster Presentation Details:

Title: 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
Abstract Number: TPS2685
Poster Session: Developmental Therapeutics—Immunotherapy
Date and Time: Monday June 2, 2025, 1:30 PM CDT
Location: Hall A
Poster Board Number: 323b

A copy of the presentation materials will be made available on the “Publications and Posters” section of the Company’s website at https://www.contexttherapeutics.com.

About CTIM-76
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on https://clinicaltrials.gov/.

About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE, CT-95, a Mesothelin x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the Company, its employees and certain ASCO presenters to participate in and present at conferences, (ii) our expectation to share initial clinical data in the first half of 2026 for CTIM-76, (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) our expectation regarding what the trial is intended to evaluate and the number of patients to be enrolled, (v) the likelihood data will support future development, and (vi) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

Investor Relations Contact:
Jennifer Minai-Azary
Chief Financial Officer
Context Therapeutics Inc.
IR@contexttherapeutics.com