NCT05830097

A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors

An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Coherent Biopharma (Hefei) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.

Detailed description

This phase Ia and Ib/II, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and phase 2 dose (RP2D). Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. Dose-limiting toxicity (DLT) observation period is 28 days. Patients in phase Ib/II part will be recruited into certain tumor cohorts and receive RP2D CBP-1019 iv infusion every two weeks. Primary efficacy of objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib/II stage.

Conditions

• Cancer, Breast
• Cancer, Lung
• Cancer of Pancreas
• Cancer of Esophagus
• Cancer Colorectal

Interventions

Type	Name	Description
DRUG	CBP-1019	Light yellow to yellow loose lumps or powder；50mg/vial; Infusion for 90 minutes (± 10 minutes), once every 2 weeks.

Timeline

• Start date: 2023-03-14
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2023-04-26
• Last updated: 2024-08-26

Locations

5 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study