Clinical trial NCT05024305: Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse events/serious adverse event related with TWP-102 injection
timeFrame: From enrollment until 90 days after the last dose
measure: Dose-limiting toxicity (DLT)
timeFrame: From the first dose of study drug up to 3 weeks
Secondary outcomes:
measure: Maximum measured plasma concentration (Cmax) of TWP-102 injection.
timeFrame: From first dose until 90 days after the last dose
measure: Time to maximum plasma concentration (Tmax) of TWP-102 injection.
timeFrame: From first dose until 90 days after the last dose
measure: Half-life (T1/2) of TWP-102 injection.
timeFrame: From first dose until 90 days after the last dose
measure: Immunogenicity profile of TWP-102 injection.
timeFrame: From first dose until 90 days after the last dose
measure: Objective Response Rate (ORR)
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Duration of Response (DOR)
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Disease control rate (DCR)
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Progression free survival (PFS)
timeFrame: From first dose to disease progression or end of study, an average of 2 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
References: