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NOT YET RECRUITING
NCT06779045
PHASE1

A Study of AK-1286 in Patients With Advanced Solid Tumors

Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

Summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of AK-1286 in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of AK-1286 and obtain the preliminary efficacy information of patients with advanced solid tumors.

Official title: A Phase 1,Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of AK-1286 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-02-01

Completion Date

2026-10-01

Last Updated

2025-01-16

Healthy Volunteers

No

Interventions

DRUG

AK-1286

Cohort 1: 1 mg/d QD AK-1286 PO,DLT observation period: 21 days. Cohort 2: 2 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 3: 4 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 4: 5 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 5: 16 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 6: 24 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 7: 36 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 8: 50 mg/d BID AK-1286 PO,DLT observation period: 21 days.