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

NCT05024305 | Unknown Phase 1

• 1 other identifier: TWP-102-11
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events/serious adverse event related with TWP-102 injection

  From enrollment until 90 days after the last dose

• Dose-limiting toxicity (DLT)

  From the first dose of study drug up to 3 weeks

Secondary Outcomes (8)

• Maximum measured plasma concentration (Cmax) of TWP-102 injection.

  From first dose until 90 days after the last dose

• Time to maximum plasma concentration (Tmax) of TWP-102 injection.

  From first dose until 90 days after the last dose

• Half-life (T1/2) of TWP-102 injection.

  From first dose until 90 days after the last dose

• Immunogenicity profile of TWP-102 injection.

  From first dose until 90 days after the last dose

• Objective Response Rate (ORR)

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

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

Four dose levels of TWP-102 injection will be tested by BOIN study design.

Drug: TWP-102 injection

Dose Expansion Cohort

EXPERIMENTAL

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

Interventions

TWP-102 injection DRUG

IV infusion

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 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong TheraWisdom Biopharma Co., Ltd.: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150001, China

RECRUITING

Central Study Contacts

Shengbin Ren

CONTACT

8021-60167707; shengbin.ren@therawisdom.com

Study Design

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

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 27, 2021
• Study Start: March 8, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: March 9, 2022

Record last verified: 2021-08

Locations

CN (1)