Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Dose Escalation Cohort Four dose levels of TWP-102 injection will be tested by BOIN study design. |
Drug: TWP-102 injection
IV infusion
|
Experimental: 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. |
Drug: TWP-102 injection
IV infusion
|
Outcome Measures
Primary Outcome Measures
- 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
- Maximum measured plasma concentration (Cmax) of TWP-102 injection. [From first dose until 90 days after the last dose]
- Time to maximum plasma concentration (Tmax) 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]
- Progression free survival (PFS) [From first dose to disease progression or end of study, an average of 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;
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At least 1 measurable lesion.
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ECOG score 0 or 1;
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Life expectancy of ≥ 3 months;
Exclusion Criteria:
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Known hypersensitivity to any ingredient of TWP-102;
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Receiving any anti-cancer drugs within 4 weeks;
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History of serious systemic diseases;
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History of serious autoimmune diseases;
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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)
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Pregnancy or lactating women.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China | 150001 |
Sponsors and Collaborators
- Shandong TheraWisdom Biopharma Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TWP-102-11