An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 15
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Have adequate bone marrow and organ function.
- •Able to comply with contraceptive/barrier requirements
排除标准
- •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