WALTHAM, Mass., October 15, 2026
Crescent Biopharma, Inc. (Nasdaq: CBIO), a clinical-stage biotechnology company focused on developing cancer therapies, announced significant progress across its oncology pipeline, including the start of enrollment in chemotherapy combination cohorts of its global Phase 1/2 ASCEND trial evaluating CR-001, an investigational PD-1 × VEGF bispecific antibody. The company has also initiated additional antibody-drug conjugate (ADC) combination studies involving CR-001, expanding its strategy to develop next-generation immuno-oncology treatments. More than 125 patients have been dosed in ASCEND across the United States, Europe and South Korea, and dose escalation has been completed. Crescent expects to report initial monotherapy data in the first quarter of 2027, including preliminary antitumor response findings from a first-line non-small cell lung cancer (NSCLC) cohort. Initial results from chemotherapy combination cohorts are anticipated in mid-2027. Separately, Crescent and its partner Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. are advancing studies combining CR-001 with the TROP2-directed ADC sacituzumab tirumotecan (sac-TMT). The company also plans to advance its ADC candidates CR-002 and CR-003. Crescent expects more than 2,000 patients to have been dosed across its portfolio by mid-2027 and, subject to clinical results and regulatory discussions, plans to initiate the first of multiple Phase 3 studies of CR-001 in early 2028.
ASCEND Trial Expands into Chemotherapy Combinations
Crescent has completed dose escalation in ASCEND, a global Phase 1/2 study evaluating CR-001 in patients with multiple solid tumor types. The trial is now enrolling participants in expansion cohorts combining CR-001 with standard-of-care chemotherapy regimens. The monotherapy data expected in Q1 2027 will include preliminary overall response rate (ORR) findings from a first-line NSCLC cohort of up to 12 patients, alongside safety, tolerability, pharmacokinetic and pharmacodynamic results from more than 125 treatment-naïve and previously treated patients. The chemotherapy combination program is expected to enroll hundreds of participants across several tumor types and treatment settings. Planned cohorts include first-line squamous and non-squamous NSCLC; first-line mismatch repair-proficient (pMMR) or microsatellite-stable (MSS) colorectal cancer; third-line colorectal cancer; first-line biliary tract cancer; first-line pMMR endometrial cancer; and first- and second-line gastric or gastroesophageal junction cancers expressing PD-L1. Regimens include CR-001 with paclitaxel and carboplatin or pemetrexed and carboplatin for NSCLC, mFOLFOX6 for first-line colorectal cancer, trifluridine and tipiracil for third-line colorectal cancer, gemcitabine and cisplatin for biliary tract cancer, carboplatin and paclitaxel for endometrial cancer, and capecitabine plus oxaliplatin or paclitaxel for gastric and gastroesophageal junction cancers. Crescent anticipates initial data from the combination cohorts in Q2 or Q3 2027. Findings from both monotherapy and combination studies are expected to inform subsequent development. The company is targeting early 2028 for the first Phase 3 CR-001 trial, subject to the results and further discussions with regulators. Trial-in-progress posters describing ASCEND’s design are scheduled for presentation at the 2026 European Society for Medical Oncology (ESMO) Congress and the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
CR-001 Development Broadens Through ADC Partnerships
Crescent is working with Kelun-Biotech to investigate CR-001 in combination with novel ADCs, including sac-TMT, a TROP2-directed antibody-drug conjugate. Under their collaboration, Kelun-Biotech holds exclusive rights to research, develop and commercialize CR-001, also known as SKB118, in Greater China. Both companies can independently develop combination regimens using CR-001 with their respective ADC pipelines. Multiple clinical studies are underway or planned in China. A Phase 2 study combining CR-001 with sac-TMT in locally advanced or metastatic NSCLC is ongoing, with initial data expected in mid-2027. Another Phase 2 study is enrolling participants with advanced solid tumors, while a further Phase 2 study is being initiated in patients with EGFR-mutant, locally advanced or metastatic non-squamous NSCLC whose disease has progressed following EGFR tyrosine kinase inhibitor therapy. Crescent and Kelun-Biotech also expect to begin a Phase 1/2 study combining CR-001 with CR-003, an integrin beta-6 (ITGB6)-targeted ADC, in the first half of 2027. The CR-001 and sac-TMT program spans more than 700 patients across NSCLC and other solid tumors, according to the company. Initial data from these combination programs are expected in mid-2027, with additional ADC combinations planned as Crescent develops CR-001 as a potential immuno-oncology treatment backbone.
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ADC Pipeline Advances with CR-002 and CR-003
Crescent is advancing two additional investigational ADC programs. CR-002, a PD-L1-targeted ADC carrying a topoisomerase inhibitor payload, recently received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration. The company plans to initiate the global Phase 1/2 APOLLO trial during the fourth quarter of 2026. The study will evaluate CR-002 in patients with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma, and gastrointestinal and gynecological cancers. Initial data are expected in the second half of 2027. CR-003, also known as SKB105, is an ITGB6-targeted ADC being evaluated in a Phase 1/2 trial in China led by Kelun-Biotech. Proof-of-concept data from that study are anticipated in Q1 2027. Crescent has exclusive rights to research, develop and commercialize CR-003 in the United States, Europe and other markets outside Greater China, and plans to use data generated in China to support its global development strategy. Chief Executive Officer Joshua Brumm said the company aims to deliver multiple clinical readouts across its immuno-oncology and ADC portfolio beginning in early 2027. All programs remain investigational, and their safety and efficacy will need to be established through clinical evaluation.
Source::: Crescent Biopharma,,press release
