drugset
drugset / Trial / NCT06403735

A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

NCT06403735 ↗

Phase 1 Recruiting 250 enrolled Qilu Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-04-25
Primary completion
2026-05-31
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject QLC1101 Small molecule 100 mg Oral
Subject QLC1101 Small molecule 200 mg Oral
Subject QLC1101 Small molecule 400 mg Oral
Subject QLC1101 Small molecule 600 mg Oral
Subject QLC1101 Small molecule 900 mg Oral
Subject QLC1101 Small molecule 1200 mg Oral

Indications

colorectal cancer malignant pancreatic neoplasm non-small cell lung carcinoma