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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHarbin Medical university cancer hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGJiangxi Cancer Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGShanghai east hospital
Shanghai, Shanghai Municipality, China
RECRUITINGYunnan Cancer Hospital
Kunming, Yunnan, China
NOT_YET_RECRUITINGDose limiting toxicity (DLT)
Subjects in this phase will be treated with single oral administration of QLC1101, observed for 4 days, and if tolerant, treated with repeated oral administration of QLC1101 twice daily for 21 consecutive days. After completing the DLT observation (the 25 days after the first dose as the DLT observation period), the subject will continue to receive repeated-dose treatment of Cycle 2 and subsequent cycles.
Time frame: 25 days after the first dose
MTD (or MAD)
the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLC1101 monotherapy
Time frame: 1 year
RP2D
the recommended phase II dose of QLC1101 monotherapy
Time frame: 1.5 years
Preliminary efficacy endpoints
Objective response rate (ORR)
Time frame: 3 years
Preliminary efficacy endpoints
overall survival (OS)
Time frame: 3 years
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