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

RecruitingPhase 1Ages 18 Years - anyAllQilu Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption; 4. Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria. 5. ECOG PS score: 0 or 1; 6. Expected survival time โ‰ฅ 3 months; 7. Adequate organ function at screening: Exclusion Criteria: 1. Previously treated with inhibitors against KRAS G12D mutation; 2. The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives 3. Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial; 4. Presence of other active malignant tumors in addition to primary tumors; 5. Presence of serious lung diseases at screening; 6. Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption; 7. Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders; 8. Complicated with clinically significant cardiovascular and cerebrovascular disorders; 9. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation); 10. Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements; 11. the investigator determines that participation in the study is not in the best interest of the subject.
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What it tests

  • QLC1101
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Where

5 sites
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China
Harbin Medical university cancer hospital
Harbin, China
Jiangxi Cancer Hospital
Nanchang, China
Shanghai east hospital
Shanghai, China
Yunnan Cancer Hospital
Kunming, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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