A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types

Официальное название

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Обзор

This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.

Подробное описание

Part 1 - Dose escalation Part 1 will evaluate increasing doses of IDE034 to assess safety, tolerability, and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in subjects with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.

Part 2 - Dose Expansion Part 2 will evaluate participants with B7-H3 and PTK7 expressing advanced/metastatic solid tumors at 2 or more dose levels determined to be safe and tolerable during dose escalation. The goal of Part 2 is to identify which of the doses evaluated in Part 1 is safe, well tolerated and results in tumor responses.

In parallel a basket cohort may be enrolled at one of the expansion dose(s) for which the tumor types and other selection criteria will be based on emerging data from nonclinical and Part 1 clinical evaluations. Additional selection criteria may be applied to the expansion indications (e.g., histological subset or select molecular alterations) based on emerging data.

Вмешательства

• Препарат IDE034
  IDE034

Первичные конечные точки

• Safety and tolerability of IDE034 in Part 1 dose escalation [Срок оценки: 21 days following the first dose of IDE034]
• Safety and tolerability of IDE034 in Part 2 dose expansion [Срок оценки: Approximately 20 months total study duration]
• To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion [Срок оценки: Time Frame: Approximately 20 months total study duration]
• To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion [Срок оценки: Time Frame: Approximately 20 months total study duration]

Вторичные конечные точки (12)

• To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation [Срок оценки: Approximately 20 months total study duration]
• To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation [Срок оценки: Approximately 20 months total study duration]
• To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation [Срок оценки: Approximately 20 months total study duration]
• To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation [Срок оценки: Approximately 20 months total study duration]
• To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion [Срок оценки: Approximately 20 months total study duration]
• To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion [Срок оценки: Approximately 20 months total study duration]
• Pharmacokinetics (PK) of IDE034 and its constituents: [Срок оценки: Approximately 20 months total study duration]
• Pharmacokinetics (PK) of IDE034 and its constituents [Срок оценки: Approximately 20 months total study duration]
• Pharmacokinetics (PK) of IDE034 and its constituents [Срок оценки: Approximately 20 months total study duration]
• Pharmacokinetics (PK) of IDE034 and its constituents [Срок оценки: Approximately 20 months total study duration]
• Pharmacokinetics (PK) of IDE034 and its constituents [Срок оценки: Approximately 20 months total study duration]
• To evaluate immunogenicity of IDE034 [Срок оценки: Approximately 20 months total study duration]

Критерии участия

Критерии включения

• Participant must be at least 18 years of age or the age of maturity per local regulations
• Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \[HER2\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.
• Archival tissue sample for testing
• Measurable disease
• Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Have adequate bone marrow and organ function.
• Able to comply with contraceptive/barrier requirements

Критерии исключения

• Known symptomatic brain metastases or leptomeningeal metastasis
• Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.
• Have uncontrolled tumor-associated pain
• Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose
• Active uncontrolled infection
• Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.
• Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.
• Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.
• Participants with known or suspected viral hepatitis
• Have history of active tuberculosis within 1 year before enrollment
• If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms
• Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP
• Administration of any of the following

• Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
• Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).
• Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP
• Have received radiotherapy within 2 weeks prior to study entry
• Have undergone major surgery or trauma within 4 weeks prior to study entry.
• Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.
• Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.
• Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody/fusion protein drugs.
• Participants with complications in the eye including ulcers in the eye, and severe dry eye

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Sarah Cannon Research Institute at HealthONE — Denver
• Florida Cancer Specialists — Sarasota
• Karmanos Cancer Institute — Detroit
• START New York Long Island, LLC — Lake Success
• SCRI Oncology Partners — Nashville
• NEXT Texas LLC - Austin — Austin
• START Dallas Fort Worth, LLC — Fort Worth
• MD Anderson — Houston
• … и ещё 7 центров

Идентификаторы

NCT: NCT07503808 · IDE034-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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