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.
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
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
Sequential
IDE034
DrugIDE034
Safety and tolerability of IDE034 in Part 1 dose escalation
Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0
Safety and tolerability of IDE034 in Part 2 dose expansion
Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Objective Response Rate (ORR) per RECIST v1.1
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Duration of Response (DoR) per RECIST v1.1
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Objective Response Rate (ORR) per RECIST v1.1
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Duration of Response (DoR) per RECIST v1.1
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Disease Control Rate (DCR) per RECIST v1.1
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Duration of response per RECIST v1.1
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