Drugs / CBP-1008
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04740398 | Mar 2019 → Sep 2024 overdue | neoplasm | Coherent Biopharma (Suzhou) Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-10-12 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory The U.S. FDA Grants Fast Track Designation to Coherent Biopharma’s CBP-1008 coherentbio.com ↗
Coherent Biopharma (“Coherent”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1008 for Injection (CBP-1008) for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC). |
| 2024-06-05 | Coherent Biopharma (Suzhou) Co., Ltd. | Results ASCO 2024 Highlights: Research findings of CBP-1008 and CBP-1018 once again attract global attention coherentbio.com ↗
The latest data as of March 12, 2024, show that CBP-1008 exhibits a controllable safety profile: a total of 267 patients were enrolled (41 in phase 1a and 226 in phase 1b). |
| 2023-10-20 | Coherent Biopharma (Suzhou) Co., Ltd. | Results Bi-XDC makes debut at the 14th World ADC Conference coherentbio.com ↗
In the 0.15 mg/kg dose group, 56 patients with platinum-resistant ovarian cancer (PROC) were evaluated for efficacy, achieving an objective response rate (ORR) of 25% and a disease control rate (DCR) of 66%. |
| 2022-07-15 | Coherent Biopharma (Suzhou) Co., Ltd. | Results ASCO 2022｜CBP-1008, first Bi-XDC, showcases its clinical data coherentbio.com ↗
The preliminary clinical results showed that CBP-1008 has manageable safety profile. |
| 2022-07-15 | Coherent Biopharma (Suzhou) Co., Ltd. | Results AACR 2022｜CBP to present study results of its leading candidate coherentbio.com ↗
Preclinical results showed that FRα+/TRPV6+ tumor responds better than tumors which have at least one marker negative. |
| 2021-06-18 | Coherent Biopharma (Suzhou) Co., Ltd. | Results CBP presented Phase Ia dose escalation study results of the first novel bi-specific ligand drug conjugate CBP-1008 in ASCO Annual Meeting coherentbio.com ↗
Results in this Phase Ia trial demonstrated that CBP-1008 was safe and well tolerated, and had clear efficacy signal in patients having expression of targeted receptors. |
| 2020-10-16 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory CBP-1008 Gets Clinical Approval by FDA coherentbio.com ↗
On October 16, 2020, CBP-1008, a bi-engaging ligand-mediated selective targeting drug conjugate developed by Coherent Biopharma, got clinical approval by FDA. |
| 2018-08-01 | Coherent Biopharma (Suzhou) Co., Ltd. | Regulatory CBP-1008, World’s First Bi-Engaging Ligand-Mediated Drug Conjugate, Approved for Clinical Trial coherentbio.com ↗
On August 1, 2018, CBP-1008 for injection, a Class I new drug independently developed by Coherent Biopharma, was approved by SFDA for clinical trial, making it the world’s first bi-engaging ligand-mediated drug conjugate entering the phase of clinical study. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CBP-1008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04740398 ↗ |
| Modality | Other / unclassified | “a bi-specific ligand conjugated drugs” NCT04740398 ↗ |
| Route | Intravenous | “IV infusion” NCT04740398 ↗ |