Status:
NOT_YET_RECRUITING
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination with Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS ...
Eligibility Criteria
Inclusion
- Subjects confirmed advanced (metastatic or unresectable) solid tumors with KRAS G12D mutations.
- Subjects who have failed or are unable to tolerate standard therapy, have no standard therapy, or refuse to receive standard therapy
- The investigator confirms that the subject has at least one measurable lesion recorded by CT and/or MRI according to RECIST v1.1
- ECOG PS score: 0 or 1
Exclusion
- Subjects who have been previously treated with inhibitors for KRAS G12D mutations
- Subjects with known immediate or delayed hypersensitivity or idiosyncratic reaction to the components of the drug products used in the study
- Subjects with known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis at screening
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06949761
Start Date
June 1 2025
End Date
June 1 2027
Last Update
April 29 2025
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