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A Phase Ib/II Study of GT90001 Combined With KN046 in Solid Tumors

NCT04984668 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-02-09

No results posted yet for this study

Summary

Phase Ib is a dose De-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of GT90001 in combination with KN046 in subjects with advanced or refractory hepatocellular carcinoma (HCC), gastric carcinoma (GC) and gastroesophageal junction (GEJ) adenocarcinoma, urothelial carcinoma (UC) and esophageal square cell carcinoma (ESCC).

Phase II is to investigate anti-tumor efficacy of GT90001 in combination with KN046 at RP2D in subjects with specific types of tumors. A Simon two-stage design is planned for each indication in order to minimize the number of treated participants if there is minimal efficacy activity in that indication.

Conditions

Interventions

DRUG

GT90001+KN046

GT90001 7.0mg/Kg， KN046 5mg/Kg

DRUG

GT90001+KN046

GT90001 7.0mg/Kg ， KN046 3mg/Kg

DRUG

GT90001/KN046

GT90001 4.5mg/Kg / KN046 5mg/Kg

DRUG

GT90001+KN046

GT90001 4.5mg/Kg， KN046 3mg/Kg

DRUG

GT90001+KN046

GT90001 3mg/Kg ， KN046 3mg/Kg

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    collaborator INDUSTRY

  • Suzhou Kintor Pharmaceutical Inc,

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2025-04-30
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984668 on ClinicalTrials.gov