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Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.

NCT05024305 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2022-03-09

No results posted yet for this study

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.

Conditions

  • Advanced Malignancies

Interventions

DRUG

TWP-102 injection

IV infusion

Sponsors & Collaborators

  • Shandong TheraWisdom Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024305 on ClinicalTrials.gov