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

Ki vehet részt

• 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

Ki nem vehet részt

• Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose
• Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose
• 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
• 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
• Active uncontrolled infection
• 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
• Known symptomatic brain metastases or leptomeningeal metastasis
• Have uncontrolled tumor-associated pain