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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: IDEAYA Biosciences

You may qualify if…

✓ 1. Participant must be at least 18 years of age or the age of maturity per local regulations
✓ 2. 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.
✓ 3. Archival tissue sample for testing
✓ 4. Measurable disease
✓ 5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
✓ 6. Have adequate bone marrow and organ function.
✓ 7. Able to comply with contraceptive/barrier requirements

You may not qualify if…

✕ 1. Known symptomatic brain metastases or leptomeningeal metastasis
✕ 2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.
✕ 3. Have uncontrolled tumor-associated pain
✕ 4. Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose
✕ 5. Active uncontrolled infection
✕ 6. 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.
✕ 7. 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.
✕ 8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.