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RECRUITING
NCT06403735
PHASE1

A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLC1101 Monotherapy in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-04-25

Completion Date

2027-04-30

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DRUG

QLC1101

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors.

Locations (5)

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Harbin Medical university cancer hospital

Harbin, Heilongjiang, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Shanghai east hospital

Shanghai, Shanghai Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China