Actively Recruiting
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-05-08
250
Participants Needed
5
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced (metastatic or unresectable) solid tumors confirmed to have KRAS G12D mutation
- Patients who have failed, cannot tolerate, lack, or refuse standard treatment
- Ability to swallow and retain oral medication without significant gastrointestinal issues
- At least one measurable tumor lesion confirmed by CT or MRI per RECIST v1.1
- ECOG Performance Status score of 0 or 1
- Expected survival time of 3 months or longer
- Adequate organ function at screening
You will not qualify if you...
- Previous treatment with inhibitors targeting KRAS G12D mutation
- Less than 28 days since prior treatment or less than 5 half-lives elapsed before first dose
- Known allergy or severe reaction to ingredients in the study drug
- Presence of other active cancers besides the primary tumor
- Serious lung diseases at screening
- Significant gastrointestinal disorders affecting drug absorption
- Severe bleeding or clotting disorders
- Significant cardiovascular or cerebrovascular conditions
- History of stem cell or organ transplantation (except corneal transplant)
- Known mental illnesses, epilepsy, dementia, or substance abuse affecting study compliance
- Investigator's judgment that participation is not in the participant's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China, 510699
Not Yet Recruiting
2
Harbin Medical university cancer hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
3
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
4
Shanghai east hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
5
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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