Testing QLC1101 for advanced solid tumors with KRAS G12D mutation

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

This study is testing a new drug called QLC1101 to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation, especially those who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT06403735 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates QLC1101, a selective reversible inhibitor targeting the KRAS G12D mutation, in patients with advanced solid tumors. The study focuses on assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug through a dose escalation and expansion approach. Participants will receive oral capsules of QLC1101, and the study aims to determine the drug's effectiveness in those who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors that have a confirmed KRAS G12D mutation and who have either failed standard treatments or are unable to tolerate them.

Not a fit: Patients who have previously been treated with inhibitors targeting the KRAS G12D mutation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors harboring the KRAS G12D mutation.

How similar studies have performed: While this approach is novel in targeting KRAS G12D specifically, similar studies targeting other KRAS mutations have shown promise.

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.

Where this trial is running

Guangzhou, Guangdong and 4 other locations

• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Harbin Medical university cancer hospital — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Shanghai east hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (NOT_YET_RECRUITING)

Conditions: Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor