NCT07467629
Not yet recruiting
Phase 1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors
Qilu Pharmaceutical Co., Ltd.1 site in 1 country100 target enrollmentStarted: April 30, 2026Last updated:
InterventionsQLS5212
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
- •Life expectancy ≥ 3 months.
- •Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and/or MRI.
- •7\. Acceptable laboratory parameters:
- •Absolute neutrophil count ≥ 1,500/μL.
- •Platelet count ≥ 100 × 1000/μL
Exclusion Criteria
- •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;
- •Clinically significant cardiovascular disease;
- •Uncontrolled systemic infection or active tuberculosis;
- •Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;
- •Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.
Arms & Interventions
QLS5212 Dose Escalation
Experimental
Intervention: QLS5212 (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD)
Time Frame: From First Patient Dosed to end of Escalation (up to 14 months).
Dose-limiting Toxicity (DLT)
Time Frame: From enrollment to 21 days of treatment.
Recommended Phase 2 dose (RP2D)
Time Frame: From First Patient Dosed to end of Escalation (up to 14 months).
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
- Maximum Plasma Concentration of QLS5212(From Day 1 of dosing through 7 days after last dose.)
- Area Under the Curve (AUC) of QLS5212(From Day 1 of dosing to 7 days after last dose.)
- Circulating anti-drug antibodies (ADA) of QLS5212(From Day 1 of dosing to 7 days after last dose.)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIVNCT07390474National Institute of Allergy and Infectious Diseases (NIAID)40
Not yet recruiting
Not Applicable
A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological MalignanciesNCT07294300Qilu Pharmaceutical Co., Ltd.124
Recruiting
Phase 1
A Clinical Trial of P134 Cells in Recurrent GlioblastomaNCT07318818Tasly Pharmaceutical Group Co., Ltd26
Recruiting
Phase 1
A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid TumorsNCT07274852Sichuan Baili Pharmaceutical Co., Ltd.22
Recruiting
Phase 1
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18