Drugs / CR-001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07335497 | Feb 2026 → Feb 2029 expected | — | Crescent Biopharma, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody kelun-biotech.com ↗
We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in China and globally. |
| 2026-01-05 | Crescent Biopharma, Inc. | Regulatory Crescent Biopharma Announces Regulatory Clearances of IND Applications for CR-001, a PD-1 x VEGF Bispecific Antibody and CR-003, an ITGB6-targeted ADC, for the Treatment of Solid Tumors crescentbiopharma.com ↗
CR-001 IND cleared by U.S. FDA; Phase 1/2 ASCEND global clinical trial to evaluate CR-001 in first-line and previously treated patients on track to initiate in first quarter of 2026, with proof-of-concept data anticipated in first quarter of 2027 |
| 2026-01-05 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC SKB105 from the NMPA kelun-biotech.com ↗
The IND application for SKB118/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. |
| 2025-11-04 | Crescent Biopharma, Inc. | Results Crescent Biopharma to Present Preclinical Data for CR-001, a PD-1 x VEGF Bispecific Antibody, at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting crescentbiopharma.com ↗
In data to be presented at SITC, CR-001 demonstrated cooperative pharmacology in vitro with increased binding to PD-1 in the presence of VEGF, augmenting the PD-1/PD-L1 signaling blockade and enhancing T-cell activation. |
All press releases naming this drug 6 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CR-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07335497 ↗ |
| Route | Intravenous | “Intravenous Infusion” NCT07335497 ↗ |