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Stock impact report

Context Therapeutics Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of CTIM-76 [Yahoo! Finance]

Context Therapeutics Inc. (CNTX) 
Company Research Source: Yahoo! Finance
“The FDA's clearance of our IND marks an important achievement for Context, allowing us to proceed with the Phase 1 clinical program for this potentially best-in-class CLDN6-targeting therapy,” said Martin Lehr, CEO of Context. “We look forward to the expected dosing of the first patient with CTIM-76 in the coming months, and we believe the Company is well-positioned to achieve key program milestones.” The Phase 1 clinical trial is expected to be 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 cancer. 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. About CTIM-76 CTIM-76 is a CLDN6 x CD3 T cell engaging bis Show less Read more
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