Clinical trialPhase 1 / Phase 2Active not recruiting
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AST-3424 in Treatment of Patients With Advanced Solid Tumors and Its Correlation With AKR1C3 Enzyme Expression
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 3 September 2019
- Expected end
- 30 November 2025
- Enrollment
- 51 participants
- Sites
- 7
- Primary outcomes
- Incidence and severity of adverse events(AEs); Safety changes in electrocardiogram (ECG); Safety Changes of body weight; Dose limiting toxicities (DLTs) in phase I; Maximum Tolerated Dose(MTD)/Recommended Phase 2 Dose (RP2D) in phase I
- Sponsor
- Industry
- Results posted
- No
- Last update
- 25 February 2025
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
An open-label, Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AST-3424 administered as a single agent
Detailed description public domain (ClinicalTrials.gov)
This is an open-label phase I/II clinical study to evaluate the safety, tolerability, MTD/RP2D, pharmacokinetics, preliminary efficacy, and the relationship between AKR1C3 expression and efficacy of AST-3424 monotherapy in advanced solid tumors. The study is divided into phase I and Phase II. The maximum tolerated dose will be explored in phase I. In phase II, participants will be treated with AST-3424 according to the Phase I confirmed dose. Phase II clinical study will first be conducted in hepatocellular carcinoma (HCC).