Business
Corbus Announces Dosing of First Patient in U.S. Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC
Study enrolling patients with metastatic urothelial cancer (mUC) and other Nectin-4 enriched tumorsEmerging clinical profile from CSPC’s Phase 1 China study
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Study enrolling patients with metastatic urothelial cancer (mUC) and other Nectin-4 enriched tumorsEmerging clinical profile from CSPC’s Phase 1 China study indicates differentiation from PADCEV NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and pharmacokinetics (PK) of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. “The initiation of our clinical trial is a significant milestone for Corbus and builds on the encouraging CRB-701 data presented by our development partner CSPC Pharmaceutical Group at ASCO-GU 2024 from the phase 1 study in China,” said Yuval Cohen, PhD. Chief Executive Office of Corbus. “Those data suggest CRB-701 has a differentiated PK and safety profile compared to PADCEV® (enfortumab vedotin-ejfv) which could translate into meaningful clinical benefits for patients with mUC and other Nectin-4 positive solid tumors.” About CRB-701CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The Nectin-4 ADC PADCEV® (enfortumab vedotin-ejfv) is approved for use in late metastatic urothelial cancer and recently received an expanded label under an accelerated approval from the Food and Drug Administration for use in combination with KEYTRUDA® for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. About CorbusCorbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by...