Clinical trial NCT06403735: A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLC1101 Monotherapy in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
Solid Tumor
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: 25 days after the first dose
measure: MTD (or MAD)
timeFrame: 1 year
measure: RP2D
timeFrame: 1.5 years
Secondary outcomes:
measure: Preliminary efficacy endpoints
timeFrame: 3 years
measure: Preliminary efficacy endpoints
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Ha'erbin
country: China
facility: Harbin Medical university cancer hospital
state: Heilongjiang
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai east hospital
state: Shanghai
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
References: