Crescent Biopharma Doses First Patient in ASCEND Phase 1/2 Trial, Reports Q1 2026 Results

Crescent Biopharma has dosed the first patient in its global ASCEND Phase 1/2 clinical trial evaluating CR-001, an investigational PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors. The company also reported first quarter 2026 financial results and provided updates across its oncology pipeline, including plans for multiple clinical trial initiations in the second half of 2026.

ASCEND (NCT07335497) is a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients. The trial is expected to enroll up to 290 patients in dose-escalation, backfill and dose-optimization cohorts at centers across the United States, Europe and Asia Pacific. The primary objectives are to evaluate the safety and tolerability of CR-001. Secondary objectives include assessment of pharmacokinetic and pharmacodynamic profiles, identification of the recommended Phase 2 dose, and evaluation of preliminary antitumor activity, including overall response rate, duration of response, progression-free survival and overall survival.

A trial-in-progress abstract of the ASCEND study design has been accepted for poster presentation during the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29-June 2, 2026 in Chicago.

CR-001 is an investigational tetravalent bispecific antibody that combines two complementary mechanisms via blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognize and destroy tumor cells, and blocking VEGF is intended to reduce blood supply to tumor cells and inhibit tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust antitumor activity.

Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts. A backfill cohort of first-line NSCLC patients is planned as part of this readout. Initial data of CR-001 in combination with standard of care chemotherapy in first-line and previously treated patients is expected by mid-2027 (Q2/Q3) utilizing the dose expansion part of the trial.

Under its strategic collaboration, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-001 in China in the first half of 2026.

Crescent also plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003. The first Phase 1/2 combination trial of CR-001 with a Kelun-Biotech ADC is expected to initiate in the second half of 2026 in China. Initial data from that combination trial is anticipated in mid-2027 (Q2/Q3).

On the broader pipeline front, CR-002, a topoisomerase inhibitor ADC targeting PD-L1, is on track for an Investigational New Drug application submission to the FDA in mid-2026 to support initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027. CR-003, an investigational topoisomerase inhibitor ADC targeting integrin beta-6 (ITGB6), has an ongoing Phase 1/2 trial in China. Multiple key clinical data readouts across the portfolio are anticipated beginning in Q1 2027.