A Study of IDE034 for Advanced Solid Tumors
This study is testing a new drug called IDE034 in adults with advanced solid tumors that have spread (metastatic) or are locally advanced. These tumors must show specific markers called B7-H3 and PTK7. The study aims to find out how safe IDE034 is, what side effects it might cause, and if it can shrink tumors. We are looking for people with certain cancers like esophageal squamous cell carcinoma, high-grade serous ovarian cancer, head and neck squamous cell carcinoma, colorectal cancer, and castration-resistant prostate cancer. The study will first test different doses of IDE034 to find the safest and most effective amount, then expand to more participants to confirm these findings.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 150 participants in total.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for approximately 20 months in total to assess the drug's effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
At a glance
Conditions
Where it's being run
15 sites across 9 statesWho to contact
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What this trial measures
- Safety and tolerability of IDE034 in Part 1 dose escalation21 days following the first dose of IDE034
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 expansionApproximately 20 months total study duration
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 expansionTime Frame: Approximately 20 months total study duration
Objective Response Rate (ORR) per RECIST v1.1
- To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansionTime Frame: Approximately 20 months total study duration
Duration of Response (DoR) per RECIST v1.1