QLS5212 for Participants With Advanced Solid Tumors

Official title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors

Overview

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.

Interventions

• Drug QLS5212
  An anti-trophoblast glycoprotein antibody-drug conjugate

Primary outcome measures

• 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 outcome measures (3)

• Maximum Plasma Concentration of QLS5212 [Time frame: From Day 1 of dosing through 7 days after last dose.]
• Area Under the Curve (AUC) of QLS5212 [Time frame: From Day 1 of dosing to 7 days after last dose.]
• Circulating anti-drug antibodies (ADA) of QLS5212 [Time frame: From Day 1 of dosing to 7 days after last dose.]

Eligibility criteria

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
• Hemoglobin ≥ 9.0 g/dL.
• Albumin ≥ 3 g/dL.
• ALT/AST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）
• Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.
• a calculated or measured creatinine clearance ≥60 mL/minute.
• Identification of an archival tumor sample (i.e., tissue block \[formalin-fixed paraffin-embedded\] or a series of approximately 10-15 slides).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanxi Provincial Cancer Hospital (China Medical Sciences Academy Cancer Hospital Shanxi H — Taiyuan

Identifiers

NCT: NCT07467629 · QLS5212-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗