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Trial Title:
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
NCT ID:
NCT06403735
Condition:
Non-small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
Solid Tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLC1101
Description:
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.
Arm group label:
QLC1101
Summary:
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.
Criteria for 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 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 ≥ 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangdong Pharmaceutical University
Address:
City:
Guangzhou
Zip:
510699
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xicheng Wang, Professor
Phone:
13902400598
Email:
13902400598@126.com
Facility:
Name:
Harbin Medical university cancer hospital
Address:
City:
Ha'erbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanqiao Zhang, Professor
Phone:
13845120210
Email:
yanqiaozhanggcp@163.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shanxian Guo, Professor
Phone:
15270019607
Email:
guoshanxian0830@126.com
Facility:
Name:
Shanghai east hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou, professor
Phone:
13301825532
Email:
caicunzhoudr@163.com
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Runxiang Yang, Professor
Phone:
13888876721
Email:
13888876721@163.com
Start date:
April 25, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06403735
