Crescent Biopharma Doses First Patient In ASCEND Phase 1/2 Trial Evaluating CR-001 For Advanced Solid Tumors

Crescent Biopharma, Inc., a clinical-stage biotechnology company committed to accelerating the next generation of cancer therapies, announced that the first patient has been dosed in its global ASCEND Phase 1/2 clinical trial. This study is designed to evaluate CR-001, an investigational bispecific antibody targeting both PD-1 and VEGF, for the treatment of advanced solid tumors. The initiation of patient dosing represents an important step forward in the development of CR-001 and brings the company closer to addressing significant unmet needs in oncology.

Ellie Im, M.D., Chief Medical Officer of Crescent, noted that beginning the ASCEND trial marks a major advancement for both the company and the CR-001 program. She emphasized that CR-001 has the potential to become a best-in-class therapy and a foundational immuno-oncology treatment in the future. By collaborating with investigators worldwide, the company aims to raise the standard of care for patients with difficult-to-treat cancers. According to Dr. Im, the trial has been designed to thoroughly evaluate the clinical potential of CR-001 across various stages of disease and to build a strong dataset that will guide strategic development across multiple cancer types.

ASCEND (NCT07335497) is a global, open-label Phase 1/2 clinical trial enrolling patients with a range of solid tumors, including non-small cell lung cancer and several gastrointestinal and gynecological malignancies. The study includes both treatment-naïve and previously treated individuals and is expected to recruit up to 290 participants across the United States, Europe, and the Asia-Pacific region. 

The primary aims of the trial are to assess the safety and tolerability of CR-001. Secondary objectives include characterizing its pharmacokinetic and pharmacodynamic properties, determining the recommended Phase 2 dose, and evaluating early signs of antitumor activity through measures such as overall response rate, duration of response, progression-free survival, and overall survival. 

Crescent expects to share proof-of-concept clinical results from ASCEND in the first quarter of 2027. These initial findings will include early safety data, pharmacokinetic and pharmacodynamic insights, and preliminary antitumor activity from the dose-escalation and backfill portions of the study.