PHILADELPHIA — September 9, 2026
Context Therapeutics Inc. announced that the first patient has been dosed in the Phase 1 clinical trial of CT-202, marking the entry of its Nectin-4 x CD3 T cell-engaging (TCE) bispecific antibody into clinical development. CT-202 is being evaluated as a potential monotherapy for patients with Nectin-4-positive solid tumors, with the initial Phase 1 program focused on recurrent, unresectable or metastatic urothelial, colorectal and triple-negative breast cancers. The open-label study is designed as a dose-escalation trial evaluating safety, tolerability, pharmacokinetics and preliminary antitumor activity. Context expects the program to generate initial Phase 1a data in the second half of 2027, providing the company with an important clinical readout as it expands its portfolio of TCE bispecific antibodies for solid tumors.
CT-202 Targets Nectin-4 With T Cell Engagement
CT-202 is designed to simultaneously target Nectin-4 on tumor cells and CD3 on T cells, creating a mechanism intended to bring immune effector cells into contact with malignant cells. Nectin-4 is a cell-surface protein frequently overexpressed across multiple solid tumors, including bladder, colorectal, lung and breast cancers. The target has already been clinically validated through antibody-drug conjugate approaches, but Context is pursuing a distinct TCE strategy. CT-202 incorporates a pH-dependent design intended to favor activity within the tumor microenvironment, potentially concentrating T-cell engagement where tumor cells are located. The company believes this differentiated design could provide a new way to exploit Nectin-4 biology while addressing the limitations associated with existing therapeutic approaches to the target.
Phase 1 Trial Evaluates Multiple Solid Tumor Indications
The Phase 1 study is evaluating CT-202 across three Nectin-4-expressing cancer types, creating an initial clinical development framework for assessing the candidate’s activity across different solid-tumor settings. The trial, identified as NCT07545122, is an open-label dose-escalation study enrolling patients with recurrent, unresectable or metastatic refractory or resistant urothelial, colorectal and triple-negative breast cancers. Key objectives include establishing the safety and tolerability profile of CT-202, characterizing pharmacokinetics and identifying preliminary signals of antitumor activity. The multi-indication design allows Context to evaluate the therapeutic potential of Nectin-4-directed T-cell engagement across tumors where the target is expressed while collecting clinical information needed to guide subsequent development. The first-patient dose therefore represents both a clinical milestone for CT-202 and an important step in defining Context’s broader solid-tumor development strategy.
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Context Builds Broader TCE Bispecific Antibody Pipeline
The CT-202 program expands Context Therapeutics’ strategy of developing TCE bispecific antibodies specifically for solid tumors, complementing the company’s existing CTIM-76 program, a Claudin 6 x CD3 TCE. The company is building its pipeline around approaches designed to harness T-cell activity against tumor-associated targets while developing differentiated molecular properties intended to address challenges in solid-tumor treatment. CT-202’s pH-dependent activity is central to its development rationale, while its focus on Nectin-4 provides access to a clinically validated tumor target across several cancer types. As the Phase 1 study progresses, Context expects safety, pharmacokinetic and preliminary efficacy data to inform future development decisions. With CT-202 now in the clinic and initial Phase 1a data expected in the second half of 2027, Context is strengthening its position in the emerging TCE bispecific field and expanding its potential therapeutic options for patients with difficult-to-treat solid tumors.
Source: Context Therapeutics, ,press release
