QLS5212 for Participants With Advanced Solid Tumors

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Maximum tolerated dose (MTD) [Срок оценки: From First Patient Dosed to end of Escalation (up to 14 months).]
• Dose-limiting Toxicity (DLT) [Срок оценки: From enrollment to 21 days of treatment.]
• Recommended Phase 2 dose (RP2D) [Срок оценки: From First Patient Dosed to end of Escalation (up to 14 months).]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later).]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07467629 · QLS5212-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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