A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types (NCT07503808) | Clinical Trial Compass
RecruitingPhase 1
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
United States150 participantsStarted 2026-02-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Safety and tolerability of IDE034 in Part 1 dose escalation
Timeframe: 21 days following the first dose of IDE034
2
Safety and tolerability of IDE034 in Part 2 dose expansion
Timeframe: Approximately 20 months total study duration
3
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Timeframe: Time Frame: Approximately 20 months total study duration
4
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Timeframe: Time Frame: Approximately 20 months total study duration
✕. 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.