CBP-1019 / Coherent Biopharma - LARVOL DELTA

Phase Ib Study of CBP-1019 in Combination with FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin (clinicaltrials.gov) - P1 | N=128 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Aug 2024

Combination therapy • Enrollment open • Metastases • Trial initiation date • Oncology • Prostate Cancer • Solid Tumor

An open-label, MRCT phase I/II study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of first-in-class bi-ligand-drug conjugate CBP-1019 in patients (pts) with advanced solid tumors (ESMO 2024) - P1/2 | "CBP-1019 as the first-in-class bi-XDC globally, was well-tolerated at 1.0 - 4.0 mg/kg Q2W without DLTs or other common severe toxicities observed in ADCs. Preliminary antitumor activity was seen at ≥2 mg/kg dose."

Clinical • Metastases • P1/2 data • PK/PD data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • TRPV6

Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin (clinicaltrials.gov) - P1 | N=128 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

Combination therapy • Metastases • New P1 trial • Oncology • Prostate Cancer • Solid Tumor

CBP-8008: A first-in-class targeted pan-Bet protein degradation therapy using bi-specific XDC (Bi-XDC) technology for TNBC and mCRPC (AACR 2024) - "Several anticancer Bi-ligand drug conjugates including CBP-1008, CBP-1018, and CBP-1019 have been brought into various clinical stages in China and US. CBP-8008 is currently in preclinical development as a potential first-in-class pan-Bet protein degradation therapy using Bi-XDC technology for TNBC and mCRPC"

Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRD2 • BRD3 • BRD4 • FOLR1

Tongyi Pharmaceutical Bi-XDC once again obtained FDA orphan drug status for esophageal cancer [Google translation] (Sohu.com) - "On April 9, Tongyi Pharmaceutical announced that the company’s independently developed second-generation Bi-XDC dual ligand coupling drug CBP-1019 has obtained orphan drug status from the U.S. FDA for the treatment of esophageal cancer....CBP-1019 is Tongyi Pharmaceutical’s second-generation Bi-XDC product."

Orphan drug • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=260 | Recruiting | Sponsor: Coherent Biopharma (Hefei) Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • FOLR1 • TRPV6

Bispecific-XDC: Novel First-in-Class Cancer Therapies From Concept to Clinical (ADC-USA 2023) - "Describing CBP-1008: a FR/ TRPV6 targeted drug conjugate in Phase II pivotal studies of advanced ovarian cancer treatment; Exploring CBP-1018: a FR/ PSMA targeted drug conjugate in Phase Ib for prostate cancer therapy; Highlighting CBP-1019: TOP1i payload drug conjugate for unmet medical needs"

Clinical • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • TRPV6

A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=260 | Active, not recruiting | Sponsor: Coherent Biopharma (Hefei) Co., Ltd.

Metastases • New P1/2 trial • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • TRPV6