Pure Global AI
NCT05867251Not yet recruiting

Study of ARTS-021 in Patients With Advanced Solid Tumors

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors
Allorion Therapeutics IncPhase 1/2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Solid Tumors
Drug/Device/Intervention
ARTS-021
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Allorion Therapeutics Inc
Timeline & enrollment
Phase
Phase 1/2
Start date
Jul 31, 2023
End date
Apr 30, 2026
Enrollment
192 participants
Primary outcome

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle,Number of Participants with Treatment Emergent Adverse Events (TEAEs) and laboratory abnormalities,Determination of Recommended Phase 2 Dose (RP2D),Objective Response Rate (ORR),Progression Free Survival (PFS),Overall Survival (OS),Time to Tumor Progression (TPP)

Summary

This study, the first clinical trial of ARTS-021, aims to determine the safety, tolerability,
 pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of
 ARTS-021 in patients with advanced solid tumors. ARTS-021 is an oral medication that inhibits
 cyclin-dependent kinase 2 (CDK 2).

ICD-10 classifications
Malignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm of other connective and soft tissueCarcinoma in situ, unspecifiedMalignant neoplasmsMalignant neoplasm: Parametrium
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05867251
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05867251 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Allorion Therapeutics Inc and is currently Not yet recruiting. The study focuses on Solid Tumors. Target enrollment is 192 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.