WALTHAM, Mass. — October 5, 2026
Crescent Biopharma, Inc. announced that the U.S. FDA has cleared the Investigational New Drug (IND) application for CR-002, its PD-L1-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) being developed for advanced solid tumors. The company plans to initiate the Phase 1/2 APOLLO global clinical trial in the fourth quarter of 2026, with the study evaluating CR-002 across multiple tumor types, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). Initial clinical data are expected in the second half of 2027, including safety, pharmacokinetic and preliminary antitumor activity findings.
CR-002 Targets PD-L1 With a Topoisomerase Inhibitor ADC
CR-002 is designed to deliver a topoisomerase inhibitor payload to PD-L1-expressing tumor cells, combining a validated tumor-associated target with an ADC approach intended to concentrate cytotoxic activity in cancer tissue. The molecule uses a PD-L1 antibody selected for high internalization, supporting intracellular delivery of the payload, along with a linker designed for intracellular cleavage and stability in circulation. PD-L1 is highly expressed across multiple solid tumors and has comparatively limited expression in healthy tissue. Crescent developed CR-002 internally in collaboration with Paragon Therapeutics, with the program supported by a preclinical rationale for treating a broad range of solid tumors.
APOLLO Phase 1/2 Trial to Evaluate Multiple Solid Tumors
The global APOLLO trial is planned to evaluate CR-002 in patients with advanced solid tumors across the United States, Europe and Asia Pacific. The study is expected to enroll approximately 200 participants during dose escalation and tumor-specific backfill cohorts, with additional enrollment possible through expansion cohorts. In addition to NSCLC and HNSCC, the trial will evaluate CR-002 in various gastrointestinal and gynecological tumors. The initial objectives will include characterization of safety, tolerability and pharmacokinetics while assessing preliminary evidence of antitumor activity across different tumor types. The company expects the trial to begin in Q4 2026 and report initial clinical results in H2 2027.
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Crescent Expands Clinical Oncology Pipeline
The CR-002 IND clearance marks the third distinct Crescent Biopharma program to enter clinical development, expanding the company’s strategy of developing therapies across multiple oncology modalities. Crescent’s pipeline includes its lead PD-1 x VEGF bispecific antibody, CR-001, alongside its growing ADC portfolio. The company also plans to evaluate CR-002 in combination with CR-001, aiming to explore potential synergy between ADC-mediated tumor killing and immuno-oncology mechanisms. With FDA clearance now secured and the APOLLO trial expected to begin in Q4 2026, Crescent is moving CR-002 from preclinical development into human testing while expanding its broader strategy for treating difficult-to-treat solid tumors.
Source: Crescent Biopharma press release
