Context Therapeutics Doses First Patient in CT-202 Phase 1 Trial
News related to:Context Therapeutics Inc · 2 min read
Context Therapeutics Inc. has announced that it has dosed the first patient in a Phase 1 clinical trial of its investigational drug CT-202, a Nectin-4 x CD3 T cell engaging bispecific antibody. The trial aims to evaluate CT-202 as a potential monotherapy for patients with Nectin-4-positive solid tumors, including urothelial, colorectal, and triple-negative breast cancers.
The drug, CT-202, is designed to target Nectin-4, a cell surface protein highly expressed in a variety of solid tumors such as bladder, colorectal, lung, and breast cancers. According to Martin Lehr, Chief Executive Officer of Context Therapeutics, this milestone is a significant step forward in the company's T cell engaging (TCE) bispecific antibody program. "Dosing the first patient marks an important milestone as we advance CT-202 into the clinic," Lehr stated.
The Phase 1 trial, designated as NCT07545122, is an open-label, dose-escalation study. It will assess the safety, tolerability, and preliminary efficacy of CT-202 in patients with Nectin-4-positive recurrent, unresectable, or metastatic refractory or resistant cancers. Context Therapeutics plans to report initial Phase 1a data in the second half of 2027, providing valuable insights into the drug's safety and potential antitumor activity.
Nectin-4, a clinically validated target for cancer therapy, has shown promise in traditional antibody-drug conjugate (ADC) treatments. However, CT-202 is designed to be pH-dependent, meaning it is more active within the tumor microenvironment, potentially reducing adverse events associated with Nectin-4-targeted therapies.
Context Therapeutics, headquartered in Philadelphia, PA, is a clinical-stage biopharmaceutical company focused on developing TCE bispecific antibodies for the treatment of solid tumors. The company's portfolio includes other TCE bispecific antibodies, such as CTIM-76, a Claudin 6 x CD3 TCE. Context aims to build an innovative pipeline of TCE bispecific therapeutics to address unmet needs in cancer treatment.
The first patient dosing in the Phase 1 trial is a key step in evaluating CT-202's potential as a new treatment option for patients with certain solid tumors. The company's ongoing research and development efforts are aimed at improving patient outcomes and addressing the significant unmet needs in the treatment of Nectin-4-positive cancers.