Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2025-05-25
Target enrollment:
Participant gender:
Summary
This is an open label, phase 1 clinical study to evaluate the safety, tolerability, dose
limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD)
and recommended phase 2 dose (RP2D) of QLS31904 q2w/q3w intravenous use in patients with
advanced solid tumors. Additional objectives are to characterise pharmacokinetics and
pharmacodynamics, and to evaluate efficacy signals. This study is consisted of phase Ia (Dose
Escalation) and phase Ib (Dose Expansion). Phase Ib will further explore QLS31904 in selected
patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and
design will be specified in a study protocol amendment after availability of phase Ia
results.