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

NCT04871334 | Unknown Phase 1

• 1 other identifier: TWP-101-11
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Melanoma; Advanced Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity (DLT)

  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.

  From enrollment until 90 days after the last dose

Secondary Outcomes (8)

• Objective Response Rate (ORR) by RECIST Version 1.1

  From first dose to disease progression or end of study, an average of 2 years

• Duration of Response (DOR)

  From first dose to disease progression, an average of 2 years

• Disease control rate (DCR).

  From first dose to disease progression or end of study, an average of 2 years

• Progression free survival (PFS).

  From first dose to disease progression or end of study, an average of 2 years

• Maximum measured plasma concentration (Cmax) of TWP-101.

  From first dose until 90 days after the last dose

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

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

Dose Expansion Cohort

EXPERIMENTAL

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

Interventions

TWP-101 DRUG

IV infusion Q2W for 4 weeks (28-day cycles)

Also known as: Sytalizumab Injection

Dose Escalation Cohort; Dose Expansion Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong TheraWisdom Biopharma Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Shengbin Ren

CONTACT

8021-60167707; shengbin.ren@therawisdom.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: February 7, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)