Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
Phase 1
- Conditions
- Advanced Malignancies
- Interventions
- Drug: TWP-102 injection
- Registration Number
- NCT05024305
- Lead Sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 81
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort TWP-102 injection Four dose levels of TWP-102 injection will be tested by BOIN study design. Dose Expansion Cohort TWP-102 injection Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.
- Primary Outcome Measures
Name Time Method Incidence of adverse events/serious adverse event related with TWP-102 injection From enrollment until 90 days after the last dose Dose-limiting toxicity (DLT) From the first dose of study drug up to 3 weeks
- Secondary Outcome Measures
Name Time Method 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 Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
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
Trial Locations
- Locations (1)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China