NCT06403735 A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
| NCT ID | NCT06403735 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2024-04-25 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT06403735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06403735 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06403735 currently recruiting?
Yes, NCT06403735 is actively recruiting participants. Visit ClinicalTrials.gov or contact Qilu Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT06403735 trial being conducted?
This trial is being conducted at Guangzhou, China, Harbin, China, Nanchang, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT06403735 clinical trial?
NCT06403735 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 250 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.