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A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
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
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