SKB103 for Injection in Advanced Solid Tumors

Официальное название

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 for Injection in Participants With Advanced Solid Tumors

Обзор

This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.

Подробное описание

This is a multi-center, open-label, phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics (PK) characteristics, immunogenicity, and efficacy of SKB103 in participants with advanced solid tumors. The study includes a Phase 1 dose escalation stage, a Phase 1 dose expansion stage, and a Phase 2 indication expansion stage.

Вмешательства

• Препарат SKB103 for injection monotherapy
  IV infusion on Day 1 of each cycle, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).

Первичные конечные точки

• Number of subjects achieving Dose-limiting toxicity (DLT) [Срок оценки: From date of initial dose until up to 21 days for treatment]
• Objective response rate (ORR) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (4)

• Progression Free Survival (PFS) [Срок оценки: Up to approximately 3 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 3 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 3 years]
• Maximum observed plasma concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348. [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Participants voluntarily joined this study and signed an informed consent form.
• The age at the time of signing the informed consent form must be between 18 and 75 years.
• Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.
• Participants should provide tumor tissue samples for biomarker testing as much as possible.
• Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.
• Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.
• Expected survival period ≥ 12 weeks.
• Participants have sufficient bone marrow, liver, kidney, and coagulation functions.
• Male and female participants must agree to use highly effective contraceptive methods during the study period.

Критерии исключения

• Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, and active central nervous system (CNS) metastasis.
• Patients with other malignant tumors within 3 years before the first administration.
• There are serious heart or vascular diseases or high-risk factors present.
• According to researchers' judgment, it is an uncontrollable systemic disease.
• There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (>1 time/week).
• History of interstitial lung disease or non infectious pneumonia.
• There are other lung diseases that may interfere with drug-related pulmonary toxicity.
• Severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
• There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.
• Within 3 months prior to the first administration, there have been clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.
• The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.
• Serious infection occurred within 4 weeks before the first administration.
• Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).
• Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
• Known active pulmonary tuberculosis.
• Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• History of allergies to any components of SKB103 injection or severe hypersensitivity reactions to other monoclonal antibodies.
• Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks before the first administration;
• Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.
• Have undergone major surgical procedures or suffered serious injuries within 4 weeks prior to the first administration of medication.
• Those who have received treatment with other clinical investigational drugs within 4 weeks prior to their first administration.
• Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 4 weeks prior to their first treatment with the investigational drug.
• Participants who received systemic corticosteroid therapy or other immunosuppressive drugs with>10 mg/day prednisone within 2 weeks prior to the first dose.
• Within 14 days before the first administration or within 5 half lives of known drugs (whichever is longer), she received a strong inhibitor or strong inducer of cytochrome P450 or a breast cancer resistance protein (BCRP) inhibitor.
• Pregnant or lactating women.
• Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.
• Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.
• Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.

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 · 2 центра

• Harbin Medical University Cancer Hospital — Харбин
• Shanghai East Hospital, Tongj.University — Шанхай

Идентификаторы

NCT: NCT07459998 · SKB103-I/II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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