Trials / Unknown
UnknownNCT05867563
Clinical Trial Evaluating the Safety of the TQB2103 for Injection
A Phase I Clinical Trial Evaluating Tolerance, Safety, Pharmacokinetics, and Initial Effectiveness of TQB2103 for Injection in Patients With Advanced Cancers.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-07-04
- Primary completion
- 2025-05-01
- Completion
- 2025-05-01
- First posted
- 2023-05-22
- Last updated
- 2023-07-10
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05867563. Inclusion in this directory is not an endorsement.