A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors

Официальное название

A Phase I/IIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.

Обзор

The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1/HLA-G/CD3. This is a Phase I/IIa study including dose-escalation, dose optimization and dose expansion parts to exam safety, tolerability, pharmacokinetics, immunogenecity and efficacy of SOA101 on advanced or metastatic solid tumor treatment.

Вмешательства

• Препарат SOA101
  Participants will receive SOA101. The RP2D will be determined based on the results of the Phase I study. During the dose expansion phase, participants will receive SOA101 at the RP2D regimen.

Первичные конечные точки

• Maximum Tolerated Dose (MTD) of SOA101 for Phase I [Срок оценки: from start until 3 months after the last dosing]
• Objective Response Rate (ORR) of SOA101 for Phase IIa [Срок оценки: from start until 3 months after the last dosing]

Вторичные конечные точки (4)

• Area Under the Curve of SOA101 (AUC) [Срок оценки: Up to end of study visit (90 days after the last dose)]
• Maximum observed plasma concentration of SOA101 (Cmax) [Срок оценки: Up to end of study visit (90 days after the last dose)]
• Half-life of SOA101 (T1/2) [Срок оценки: Up to end of study visit (90 days after the last dose)]
• Overall Response Rate (ORR) [Срок оценки: Up to end of study visit (90 days after the last dose)]

Критерии участия

Критерии включения

• Male or female subjects aged ≥ 18 years old.
• Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists:

• Non-small cell lung cancer (NSCLC);
• Ovarian cancer (OC);
• Head and neck carcinoma (H\&N);
• Breast cancer (BC);
• Colorectal cancer (CRC).
• Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.
• At least one measurable lesion
• Adequate organ function
• Female subject must either not be of childbearing potential or a negative pregnancy test
• Non-vasectomized male subjects must practice highly effective contraception

Критерии исключения

• Active bacterial, fungal, viral OR atypical infection requiring systemic medication.
• Received any investigational drug within 4 weeks before screening.
• Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection.
• Symptomatic, unstable central nervous system malignancy OR metastasis
• Have received organ or tissue transplantation or allogeneic cell therapies.
• Non-adequate cardiac function
• Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.

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

Тайвань · 1 центр

• China Medical University Hospital — Taichung

Публикации

• Lin YC, Chen MC, Huang SW, Chen Y, Ho JH, Lin FY, Tan XT, Chiang HC, Huang CC, Tu CY, Cho DY, Chiu SC. Targeting Dual Immune Checkpoints PD-L1 and HLA-G by Trispecific T Cell Engager for Treating Heterogeneous Lung Cancer. Adv Sci (Weinh). 2024 Nov;11(41):e2309697. doi: 10.1002/advs.202309697. Epub 2024 Sep 5. PMID 39234811

Идентификаторы

NCT: NCT07055594 · SOA101-CL-Proto-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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