QLS5212 for Participants With Advanced Solid Tumors
ConditionSolid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
Age ≥ 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Disqualifiers
History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;
Untreated or active brain metastases, including leptomeningeal carcinomatosis;
Prior systemic anti-cancer therapy within specified windows;
Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;
Trial design
Design model
Single group
Treatments tested in this trial
QLS5212
DrugAn anti-trophoblast glycoprotein antibody-drug conjugate
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: QLS5212 Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD)
Time frame
From First Patient Dosed to end of Escalation (up to 14 months).2
Dose-limiting Toxicity (DLT)
Time frame
From enrollment to 21 days of treatment.3
Recommended Phase 2 dose (RP2D)
Time frame
From First Patient Dosed to end of Escalation (up to 14 months).4
Incidence of Treatment-Emergent Adverse Events
Time frame
From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later).Secondary outcomes
1
Maximum Plasma Concentration of QLS5212
Time frame
From Day 1 of dosing through 7 days after last dose.2
Area Under the Curve (AUC) of QLS5212
Time frame
From Day 1 of dosing to 7 days after last dose.3
Circulating anti-drug antibodies (ADA) of QLS5212
Time frame
From Day 1 of dosing to 7 days after last dose.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov