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

Sponsor
Shandong TheraWisdom Biopharma Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05024305
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TWP-102 injection
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events/serious adverse event related with TWP-102 injection [From enrollment until 90 days after the last dose]

  2. Dose-limiting toxicity (DLT) [From the first dose of study drug up to 3 weeks]

Secondary Outcome Measures

  1. Maximum measured plasma concentration (Cmax) of TWP-102 injection. [From first dose until 90 days after the last dose]

  2. Time to maximum plasma concentration (Tmax) of TWP-102 injection. [From first dose until 90 days after the last dose]

  3. Half-life (T1/2) of TWP-102 injection. [From first dose until 90 days after the last dose]

  4. Immunogenicity profile of TWP-102 injection. [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.

  5. Objective Response Rate (ORR) [From first dose to disease progression or end of study, an average of 2 years]

  6. Duration of Response (DOR) [From first dose to disease progression or end of study, an average of 2 years]

  7. Disease control rate (DCR) [From first dose to disease progression or end of study, an average of 2 years]

  8. Progression free survival (PFS) [From first dose to disease progression or end of study, an average of 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150001

Sponsors and Collaborators

  • Shandong TheraWisdom Biopharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shandong TheraWisdom Biopharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05024305
Other Study ID Numbers:
  • TWP-102-11
First Posted:
Aug 27, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022