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

Recruiting Phase 1 Interventional Study
Non-small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Solid Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF. 2. Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment; 3. Those w…
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