Study of QLS5308 in Patients With Advanced Solid Tumors
ConditionMetastatic Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.
Eligibility criteria
Qualifiers
Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.
Has adequate organ function.
The expected survival period is ≥3 months.
Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.
Disqualifiers
Prior treatment with LIV1-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.
There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.
Active, uncontrolled bacterial, fungal or viral infections.
Participants with moderate to large amounts of uncontrolled pleural, pericardial, or peritoneal effusions before the first dose (those who remain stable for at least 2 weeks after drainage may be enrolled).
Trial design
Treatments tested in this trial
- QLS5308 IV infusion
Treatment groups
192 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov