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

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.

Trial Details

NCT ID

NCT06403735

Phase

PHASE1

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

RECRUITING

Cancer Type

Pancreatic Cancer

Interventions

QLC1101

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25
Harbin, Heilongjiang, China|45.75,126.65
Nanchang, Jiangxi, China|28.68396,115.85306
Shanghai, Shanghai Municipality, China|31.22222,121.45806
Kunming, Yunnan, China|25.03889,102.71833

Key Eligibility Criteria

Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter a…
Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the…

For full eligibility, visit ClinicalTrials.gov.

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