Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

July 20, 2021 updated by: Shandong TheraWisdom Biopharma Co., Ltd.

A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

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
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking university cancer hospital
        • Contact:

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 or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
  • ECOG score 0 or 1;
  • Part B: At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

  • Known hypersensitivity to any ingredient of TWP-101;
  • Receiving any anti-cancer drugs;
  • History of serious systemic diseases;
  • History of serious autoimmune diseases;
  • 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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Expansion Cohort
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
Drug: TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Other Names:
  • Sytalizumab Injection
Experimental: Dose Escalation Cohort
Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.
Drug: TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Other Names:
  • Sytalizumab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicity (DLT)
Time Frame: From the first dose of study drug up to 4 weeks
From the first dose of study drug up to 4 weeks
Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
Time Frame: From enrollment until 90 days after the last dose
From enrollment until 90 days after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by RECIST Version 1.1
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, an average of 2 years
From first dose to disease progression, 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
Maximum measured plasma concentration (Cmax) of TWP-101.
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-101.
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-101.
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-101.
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 by meso scale discovery(MSD).
From first dose until 90 days after the last dose

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)

February 7, 2021

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWP-101-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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