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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
QLS5308 IV infusion
DrugParticipants will receive escalating doses of QLS5308 (0.8, 1.6, 3.2, 4.0, 4.8, 5.6, 6.4 mg/kg) intravenously on Day 1 of each 21-day cycle.
Treatment groups
192 Participants
are divided into 1 treatment groupGroup A: Arm A: QLS5308Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors.
Time frame
up to 12 months2
Number of participants who experience one or more adverse events(AEs).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame
up to 48 monthsSecondary outcomes
1
Objective Response Rate
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator.
Time frame
up to 36 months2
DOR
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator.
Time frame
up to 48 months3
PFS
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version1.1 (RECIST 1.1). PD is defined as ≥20%increase in the sum of diameters of target lesions. In addition to the relative increase of20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearanceof one or more new lesions is alsoconsidered PD. PFS as assessed by investigator.
Time frame
up to 48 months4
OS
OS is defined as the time from randomization to death due to any cause.
Time frame
up to 60 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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