Advanced Malignancies
Conditions
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.
Interventions
DRUGTWP-102 injection
IV infusion
Sponsors
Shandong TheraWisdom Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Maximum measured plasma concentration (Cmax) of TWP-102 injection. | From first dose until 90 days after the last dose | — |
| 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 | — |
| Duration of Response (DOR) | 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 | — |
Countries
China
Contacts
Primary ContactShengbin Ren
Outcome results
None listed