A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
Overview
- Phase
- Phase 1
- Intervention
- TWP-102 injection
- Conditions
- Advanced Malignancies
- Sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events/serious adverse event related with TWP-102 injection
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;
- •At least 1 measurable lesion.
- •ECOG score 0 or 1;
- •Life expectancy of ≥ 3 months;
Exclusion Criteria
- •Known hypersensitivity to any ingredient of TWP-102;
- •Receiving any anti-cancer drugs within 4 weeks;
- •History of serious systemic diseases;
- •History of serious autoimmune diseases;
- •Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \> 1 severity that is related to prior anti-cancer therapy. (except alopecia)
- •Pregnancy or lactating women.
Arms & Interventions
Dose Escalation Cohort
Four dose levels of TWP-102 injection will be tested by BOIN study design.
Intervention: TWP-102 injection
Dose Expansion Cohort
Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.
Intervention: TWP-102 injection
Outcomes
Primary Outcomes
Incidence of adverse events/serious adverse event related with TWP-102 injection
Time Frame: From enrollment until 90 days after the last dose
Dose-limiting toxicity (DLT)
Time Frame: From the first dose of study drug up to 3 weeks
Secondary Outcomes
- Progression free survival (PFS)(From first dose to disease progression or end of study, an average of 2 years)
- Time to maximum plasma concentration (Tmax) of TWP-102 injection.(From first dose until 90 days after the last dose)
- Maximum measured plasma concentration (Cmax) of TWP-102 injection.(From first dose until 90 days after the last dose)
- Half-life (T1/2) of TWP-102 injection.(From first dose until 90 days after the last dose)
- Immunogenicity profile of TWP-102 injection.(From first dose until 90 days after the last dose)
- Objective Response Rate (ORR)(From first dose to disease progression or end of study, an average of 2 years)
- Duration of Response (DOR)(From first dose to disease progression or end of study, an average of 2 years)
- Disease control rate (DCR)(From first dose to disease progression or end of study, an average of 2 years)