Clinical trialPhase 1Completed
Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors
An Open, Two-stage, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 4 June 2020
- Expected end
- 28 September 2023
- Enrollment
- 62 participants
- Sites
- 12
- Primary outcomes
- Stage1：Incidence of adverse events AE of single and multiple dose (according to NCI CTCAE 5.0); Stage1：Incidence of adverse events SAE of single and multiple dose (according to NCI CTCAE 5.0); Stage 1: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period; Stage 2：Incidence of adverse events AE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0); Stage 2：Incidence of adverse events SAE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 24 May 2024
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Brief summary public domain (ClinicalTrials.gov)
This is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors.
Detailed description public domain (ClinicalTrials.gov)
This study is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors. The study is composed of two stages: stage I is single treatment and stage II is combo treatment.