Clinical trial · Interventional
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLC1101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLC1101
- description
- patients with advanced solid tumors harboring a KRAS G12D mutation were administrated with QLC1101 orally in a total of 6 dose groups at 100,200,400,600,900, and 1200 mg BID
- interventionNames
- Drug: QLC1101
Primary outcomes (3)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 25 days after the first dose
- description
- Subjects in this phase will be treated with single oral administration of QLC1101, observed for 4 days, and if tolerant, treated with repeated oral administration of QLC1101 twice daily for 21 consecutive days. After completing the DLT observation (the 25 days after the first dose as the DLT observation period), the subject will continue to receive repeated-dose treatment of Cycle 2 and subsequent cycles.
- measure
- MTD (or MAD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available