Drugs / CBP-1019
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06576037 | Oct 2024 → Jun 2027 expected | neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05830097 | Mar 2023 → Jun 2025 | breast cancer, colorectal cancer, esophageal cancer, lung cancer +1 | Coherent Biopharma (Hefei) Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory The U.S. FDA Grants Fast Track Designation to Coherent Biopharma’s CBP-1019 coherentbio.com ↗
Coherent Biopharma (“Coherent”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1019 for Injection (CBP-1019) for the treatment of recurrent endometrial cancer (EC) after at least one line of platinum-based systemic therapy. |
| 2024-06-26 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory Coherent Biopharma’s CBP-1019 has received Orphan Drug Designation from the FDA for three indications coherentbio.com ↗
On June 24, 2024, local time, the U.S. Food and Drug Administration (FDA) notified the approval of Orphan Drug Designation (ODD) for CBP-1019, the second-generation Bi-XDC bispecific ligand drug conjugate independently developed by Coherent Biopharma, for the treatment of small cell lung cancer (SCLC). |
| 2023-09-20 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory CBP-1019 has received FDA Orphan Drug Designation coherentbio.com ↗
Coherent Biopharma announced today that their proprietary second-generation dual-ligand conjugate drug, CBP-1019, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) on September 20, 2023, for the treatment of pancreatic cancer. |
| 2023-01-20 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory CBP Announces FDA IND Approval for CBP-1019 for Clinical Trial coherentbio.com ↗
The third Bi-Ligand-Drug conjugate CBP-1019 of Coherent Biopharma was granted the FDA’s clinical implied licenseon January 18, 2023. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Coherent Biopharma (Suzhou) Co., Ltd. | The U.S. FDA Grants Fast Track Designation to Coherent Biopharma’s CBP-1019 coherentbio.com ↗ |
| 2024-06-26 | Coherent Biopharma (Suzhou) Co., Ltd. | Coherent Biopharma’s CBP-1019 has received Orphan Drug Designation from the FDA for three indications coherentbio.com ↗ |
| 2023-09-20 | Coherent Biopharma (Suzhou) Co., Ltd. | CBP-1019 has received FDA Orphan Drug Designation coherentbio.com ↗ |
| 2023-01-20 | Coherent Biopharma (Suzhou) Co., Ltd. | CBP Announces FDA IND Approval for CBP-1019 for Clinical Trial coherentbio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CBP-1019 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06576037 ↗ |
| Modality | Other / unclassified | “CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.” NCT05830097 ↗ |
| Route | Intravenous | “receive CBP-1019 IV infusion every 2 weeks” NCT05830097 ↗ |