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

Primary Purpose

Advanced Melanoma, Advanced Urothelial Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TWP-101
Sponsored by
Shandong TheraWisdom Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation Cohort

Dose Expansion Cohort

Arm Description

Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

Outcomes

Primary Outcome Measures

Incidence of dose-limiting toxicity (DLT)
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.

Secondary Outcome Measures

Objective Response Rate (ORR) by RECIST Version 1.1
Duration of Response (DOR)
Disease control rate (DCR).
Progression free survival (PFS).
Maximum measured plasma concentration (Cmax) of TWP-101.
Time to maximum plasma concentration (Tmax) of TWP-101.
Half-life (T1/2) of TWP-101.
Immunogenicity profile of TWP-101.
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).

Full Information

First Posted
April 29, 2021
Last Updated
July 20, 2021
Sponsor
Shandong TheraWisdom Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04871334
Brief Title
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong TheraWisdom Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma, Advanced Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Cohort
Arm Type
Experimental
Arm Description
Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.
Arm Title
Dose Expansion Cohort
Arm Type
Experimental
Arm Description
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
Intervention Type
Drug
Intervention Name(s)
TWP-101
Other Intervention Name(s)
Sytalizumab Injection
Intervention Description
IV infusion Q2W for 4 weeks (28-day cycles)
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicity (DLT)
Time Frame
From the first dose of study drug up to 4 weeks
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Duration of Response (DOR)
Time Frame
From first dose to disease progression, an average of 2 years
Title
Disease control rate (DCR).
Time Frame
From first dose to disease progression or end of study, an average of 2 years
Title
Progression free survival (PFS).
Time Frame
From first dose to disease progression or end of study, an average of 2 years
Title
Maximum measured plasma concentration (Cmax) of TWP-101.
Time Frame
From first dose until 90 days after the last dose
Title
Time to maximum plasma concentration (Tmax) of TWP-101.
Time Frame
From first dose until 90 days after the last dose
Title
Half-life (T1/2) of TWP-101.
Time Frame
From first dose until 90 days after the last dose
Title
Immunogenicity profile of TWP-101.
Description
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).
Time Frame
From first dose until 90 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengbin Ren
Phone
8021-60167707
Email
shengbin.ren@therawisdom.com
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo
Phone
010-88121122
Email
guoj307@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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