Clinical trialPhase 1 / Phase 2Unknown
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
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- 14 March 2023
- Expected end
- 30 September 2025
- Enrollment
- 260 participants
- Sites
- 5
- Primary outcomes
- Incidence and severity of Adverse Events (AEs)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 26 August 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.