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Clinical Trial Evaluating the Safety of the TQB2103 for Injection

NCT05867563 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2023-07-10

No results posted yet for this study

Summary

TQB2103 injection is an antibody-drug conjugate (ADC) targeting claudin (CLDN) 18.2. This study aimed to evaluate the safety and tolerability, pharmacokinetic characteristics and immunogenicity of TQB2103 injection in patients with advanced malignant tumors as well as its initial effectiveness.

Conditions

  • Advanced Malignant Neoplasm

Interventions

DRUG

TQB2103 for injection

TQB2103 for injection is an antibody-drug conjugate targeting CLDN18.2. The drug structure mainly includes anti-humanized CLDN 18.2 antibody, linker and cytotoxic DDDXD, with Drug antibody Ratio (DAR) of 8.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • China

Study Locations

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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 NCT05867563 on ClinicalTrials.gov