Clinical trialEarly Phase 1Not yet recruiting
BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies
Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrent/refractory Gastrointestinal Malignancies
- Outcome
- Ongoing
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 30 November 2024
- Expected end
- 31 August 2027
- Enrollment
- 15 participants
- Sites
- 0
- Primary outcomes
- Dose-Limiting Toxicity (DLT); Maximum Tolerated Dose(MTD)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 16 October 2024
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Brief summary public domain (ClinicalTrials.gov)
This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 \^ 8 3 cases, Group B: 6.0X10 \^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.
Detailed description public domain (ClinicalTrials.gov)
Main research objectives: Evaluate the safety and tolerability of BGT007 in treating patients with recurrent/refractory multiple gastrointestinal malignancies; Secondary research objective: 1. Evaluate the pharmacokinetic (PK) characteristics of BGT007; 2. Evaluate the preliminary effectiveness of BGT007 product.