Context Therapeutics Announces First Patient Dosed in Phase 1 Trial of CT-202

Context Therapeutics (CNTX) has dosed the first patient in its Phase 1 clinical trial of CT-202, a Nectin-4 x CD3 T cell engaging bispecific antibody for solid tumors.

Rhea-AI Summary

Context Therapeutics (CNTX) has dosed the first patient in its Phase 1 clinical trial of CT-202, a Nectin-4 x CD3 T cell engaging bispecific antibody for solid tumors.

The open-label, dose-escalation study (NCT07545122) is evaluating CT-202 as a monotherapy in patients with Nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant urothelial, colorectal, and triple-negative breast cancers. The trial is designed to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity, as well as early signals of efficacy.

The company describes CT-202 as a differentiated Nectin-4 x CD3 program targeting tumors with substantial unmet medical needs and expects to report initial Phase 1a data in the second half of 2027. CT-202 is part of Context’s broader pipeline of T cell engaging bispecific antibodies being advanced for the treatment of solid tumors.

Market Context

CNTX was up 4.04% pre-headline at publication, while comparable biotechnology stocks moved in mixed ...

Analysis

CNTX was up 4.04% pre-headline at publication, while comparable biotechnology stocks moved in mixed directions; the divergence provided no evidence of a broad peer move alongside the CT-202 dosing announcement.

Key Figures

First patient dosed: 1 patient Initial Phase 1a data: Second half of 2027

First patient dosed

1 patient

Phase 1 CT-202 trial

Initial Phase 1a data

Second half of 2027

Expected reporting timeline

Key Terms

bispecific antibody, pharmacokinetics, monotherapy, dose escalation, +1 more

5 terms

bispecific antibody medical

"a Nectin-4 x CD3 TCE bispecific antibody"

A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.

pharmacokinetics medical

"safety, tolerability, pharmacokinetics and preliminary antitumor activity"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

monotherapy medical

"evaluated as a potential monotherapy for patients"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

dose escalation medical

"an open-label, dose escalation trial designed to evaluate"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

open-label medical

"is an open-label, dose escalation trial"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

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CT-202 is a Nectin-4 x CD3 T cell engaging bispecific antibody

Phase 1 trial is evaluating CT-202 as a monotherapy treatment in patients with urothelial, colorectal, and triple-negative breast cancers

PHILADELPHIA, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced that the first patient has been dosed in the Phase 1 clinical trial of CT-202, a Nectin-4 x CD3 TCE bispecific antibody.

“Dosing the first patient in the Phase 1 trial of CT-202 marks an important milestone as we advance our differentiated Nectin-4 x CD3 program into the clinic,” said Martin Lehr, Chief Executive Officer of Context. “CT-202 is being evaluated as a potential monotherapy for patients with Nectin-4-positive tumors, where substantial unmet needs exist. We believe this study will provide important insights into CT-202’s safety, tolerability, pharmacokinetics and preliminary antitumor activity, and we look forward to reporting initial Phase 1a data in the second half of 2027.”

The Phase 1 study (NCT07545122) is an open-label, dose escalation trial designed to evaluate safety, tolerability, and preliminary efficacy in patients with Nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant urothelial, colorectal and triple-negative breast cancers.

About CT-202

CT-202 is a Nectin-4 x CD3 TCE bispecific antibody that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate, but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. More information about the CT-202 clinical trial (NCT07545122) 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’s goal is to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia, PA. 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” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company’s strategy, future operations, prospects, and plans and objectives of management, are forward-looking statements. These statements may be identified by words such as “may,” “will,” “expect,” “believe,” “could,” “estimate,” “potential,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions.

Forward-looking statements in this press release include, without limitation, statements regarding: (i) plans related to the Company’s research and development activities, and the expected timing and potential results thereof; and (ii) other non-historical statements.

These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied, and the Company cannot assure that its plans, intentions, expectations, or strategies will be achieved. These risks and uncertainties include, without limitation: (i) uncertainties regarding the Company’s expectations, projections, and estimates of future costs and expenses, capital requirements, the availability of additional financing and the Company’s capital requirements; (ii) the timing, progress, and results of the Company’s discovery, preclinical and clinical development activities; (iii) uncertainties regarding the Company’s ability to successfully implement its portfolio prioritization and capital allocation strategy, including the discontinuation of internal development of CT-95, and the possibility that the Company’s estimates of the costs, expenses, savings or other financial impacts associated with such prioritization may be incorrect or may change; (iv) clinical trial site activation and enrollment; (v) unexpected safety or efficacy data observed during preclinical studies or clinical trials; (vi) the risk that results from nonclinical or clinical studies may not be predictive of future results, and that interim data are subject to further analysis; (vii) uncertainties related to the regulatory approval process; (viii) the Company’s reliance on third parties; (ix) macroeconomic conditions; and (x) whether the Company has sufficient funding to meet future operating expenses and capital expenditure requirements. Additional factors that may cause actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission (the “SEC”), and in the Company’s other filings with the SEC, including future reports.

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

FAQ

What is CT-202 and how is it intended to work?

CT-202 is a Nectin-4 x CD3 T cell engaging bispecific antibody. It is designed to bind Nectin-4 on tumor cells and CD3 on T cells, engaging the patient’s immune system to target Nectin-4-expressing cancers. The company is developing CT-202 as a potential monotherapy for patients with Nectin-4-positive tumors where unmet medical needs remain.

Which patients are eligible for the Phase 1 CT-202 trial?

The Phase 1 study enrolls patients with Nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant urothelial, colorectal, and triple-negative breast cancers. These patients receive CT-202 as monotherapy in an open-label, dose escalation setting.

What are the main objectives of the Phase 1 CT-202 study?

The trial is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CT-202, along with early assessments of preliminary efficacy in the enrolled patient population.

When does Context Therapeutics expect to share initial CT-202 trial data?

Context Therapeutics expects to report initial Phase 1a data in the second half of 2027, based on the company’s current development plans.