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Study of ARTS-021 in Patients With Advanced Solid Tumors - Trial NCT05867251

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.

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NCT05867251
Phase 1/2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05867251
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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

Study Focus

Solid Tumors

ARTS-021

Interventional

drug

Sponsor & Location

Allorion Therapeutics Inc

Timeline & Enrollment

Phase 1/2

Jul 31, 2023

Apr 30, 2026

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, unspecified
Malignant neoplasm of other connective and soft tissue
Carcinoma in situ, unspecified
Malignant neoplasms
Malignant neoplasm: Parametrium

Data Source

ClinicalTrials.gov

NCT05867251

Non-Device Trial