Actively Recruiting
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
Led by IDEAYA Biosciences · Updated on 2026-03-31
150
Participants Needed
5
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 18 years of age or the age of maturity per local regulations
- Have advanced, recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in specific cancers: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC, CRC, or CRPC
- Tumors must have progressed or recurred after at least one prior therapy or participant is intolerant to further standard treatments
- Availability of archival tissue sample for testing
- Measurable disease confirmed
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow and organ function
- Ability to comply with contraceptive or barrier methods requirements
You will not qualify if you...
- Known symptomatic brain metastases or leptomeningeal metastasis
- Known primary central nervous system malignancy or other malignancies within 2 years prior to first dose
- Uncontrolled tumor-associated pain
- Clinically significant cardiac abnormalities or cerebrovascular disease within 6 months before first dose
- Active uncontrolled infection
- History or current interstitial pneumonitis or moderate to severe lung diseases affecting respiratory function within 3 months before first dose
- Severe infections requiring hospitalization within 4 weeks prior to study treatment
- History of immunodeficiency or positive HIV test at screening
- Known or suspected viral hepatitis
- History of active tuberculosis within 1 year before enrollment
- Unresolved adverse reactions or peripheral neurological symptoms from prior antitumor treatment
- Recent chemotherapy within 3 weeks or immunotherapy, biologic targeted therapy, or investigational products within 3-4 weeks prior to first dose
- Current or anticipated use of strong CYP3A4/5 inhibitors or inducers
- Prior treatment with B7-H3 or PTK7 antibody-drug conjugates
- Prior treatment with topoisomerase I inhibitors including ADCs within 6 months
- Recent radiotherapy within 2 weeks prior to study entry
- Major surgery or trauma within 4 weeks prior to study entry
- Recent live attenuated vaccine within 28 days prior to first dose or expected during study
- Female participants who are pregnant, lactating, or planning pregnancy during study and up to 7 months after last dose
- Known allergy to IDE034 components or severe allergic reactions to similar drugs
- Eye complications including ulcers or severe dry eye
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
NEXT Texas LLC - Austin
Austin, Texas, United States, 78758
Actively Recruiting
2
NEXT Texas LLC - Houston
Houston, Texas, United States, 77054
Actively Recruiting
3
NEXT Texas LLC - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
4
NEXT Texas LLC - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
5
NEXT Texas LLC - Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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