QLF4113 in Participants With Metastatic Prostate Cancer

Официальное название

An Open-label, Multicenter Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLF4113 for Injection in Participants With Metastatic Prostate Cancer.

Обзор

This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer. The Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.

Вмешательства

• Препарат QLF4113 for injection
  A PSMA/CD3/CD2 antibody

Первичные конечные точки

• Maximum tolerated dose (MTD) (Phase Ia) [Срок оценки: From first dose of study treatment until the end of Cycle 1 (21 days)]
• Maximum administered dose (MAD)(Phase Ia) [Срок оценки: From first dose of study treatment until the end of Cycle 1 (21 days)]
• recommended phase II dose (RP2D) [Срок оценки: Through phase Ia completion, approximately 1 year.]
• The incidence and severity of adverse events (AE) (Phase Ib) [Срок оценки: Through phase Ia completion, approximately 1 year.]
• PSA50 response (Phase Ib) [Срок оценки: From Screening to confirmed progressive disease (approximately 1 year)]
• Objective response rate (ORR) (phase Ib) [Срок оценки: From Screening to confirmed progressive disease (approximately 1 year)]

Критерии участия

Критерии включения

• Participants voluntarily agree to participate and sign the informed consent form.
• Male, aged ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features.
• Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC).
• Failed or are intolerant to standard therapies
• Adequate function of major organs as defined by the protocol.
• Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).
• Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments

Критерии исключения

• Previously treated with drugs targeting CD3 or CD2.
• Significant Cardiovascular Diseases
• Active, Uncontrolled Infections
• Immunosuppressive Treatment before the first dose of the investigational drug
• Clinically Uncontrolled Third-Space Fluid Accumulation
• History of Other Malignancies within 5 years prior to the first dose of the investigational drug
• Moderate to Severe Pulmonary Diseases significantly affecting lung function,
• Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse.
• Allergy to the Investigational Drug or its Components.
• Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07636707 · QLF4113-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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