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

March 7, 2022 updated by: Shandong TheraWisdom Biopharma Co., Ltd.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

81

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Qingyuan Zhang
          • Phone Number: 0451-86298070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events/serious adverse event related with TWP-102 injection
Time Frame: From enrollment until 90 days after the last dose
From enrollment until 90 days after the last dose
Dose-limiting toxicity (DLT)
Time Frame: From the first dose of study drug up to 3 weeks
From the first dose of study drug up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum measured plasma concentration (Cmax) of TWP-102 injection.
Time Frame: From first dose until 90 days after the last dose
From first dose until 90 days after the last dose
Time to maximum plasma concentration (Tmax) of TWP-102 injection.
Time Frame: From first dose until 90 days after the last dose
From first dose until 90 days after the last dose
Half-life (T1/2) of TWP-102 injection.
Time Frame: From first dose until 90 days after the last dose
From first dose until 90 days after the last dose
Immunogenicity profile of TWP-102 injection.
Time Frame: 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.
From first dose until 90 days after the last dose
Objective Response Rate (ORR)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
From first dose to disease progression or end of study, an average of 2 years
Duration of Response (DOR)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
From first dose to disease progression or end of study, an average of 2 years
Disease control rate (DCR)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
From first dose to disease progression or end of study, an average of 2 years
Progression free survival (PFS)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
From first dose to disease progression or end of study, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong TheraWisdom Biopharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

August 22, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWP-102-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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