Actively Recruiting
An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Led by IDEAYA Biosciences · Updated on 2026-03-31
150
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IDE034, a drug for adults with locally advanced or metastatic solid tumors that express B7-H3 and PTK7 proteins. This Phase 1a/1b open-label study aims to assess the safety, how the body processes the drug, immune response, and early signs of effectiveness in these cancer types. The study involves participants with tumors such as non-small cell lung cancer, esophageal squamous cell carcinoma, ovarian cancer, head and neck cancer, triple negative breast cancer, colorectal cancer, and prostate cancer that have progressed after prior treatments. The study has two parts. Part 1 involves gradually increasing doses of IDE034 to find the highest dose that participants can tolerate without severe side effects. Part 2 expands to treat more participants at selected doses from Part 1 to further assess safety and early tumor responses. There is also a basket cohort planned, which may include certain tumor types or molecular features based on emerging study data. Treatment involves receiving IDE034 under medical supervision at study centers. Participants will undergo safety monitoring, tumor assessments, and blood tests throughout the study, which may last approximately 20 months. Researchers will evaluate how well participants tolerate the drug, its effects on tumors, and its behavior in the body. Regular check-ups will include imaging scans, laboratory tests, and immune response evaluations. The study team will also monitor for any side effects during and after treatment to understand the drug's safety profile.
CONDITIONS
Brief 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...
- At least 18 years of age or the age of maturity per local regulations
- Advanced, recurrent, or metastatic solid tumors expressing B7-H3 and PTK7 in NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC, CRC, or CRPC
- Disease has progressed or recurred after at least one line of therapy or participant is intolerant to standard therapies
- Availability of archival tissue sample for testing
- Measurable disease present
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow and organ function
- Ability to comply with contraceptive or barrier requirements
You will not qualify if you...
- Known symptomatic brain metastases or leptomeningeal metastasis
- Known primary central nervous system malignancy or any other malignancies within 2 years prior to first dose
- Uncontrolled tumor-associated pain
- Significant cardiac abnormalities or cerebrovascular disease within 6 months prior to first dose
- Active uncontrolled infection
- History of interstitial pneumonitis or other moderate to severe lung diseases affecting breathing within 3 months prior to first dose
- Severe infections requiring hospitalization within 4 weeks prior to treatment start
- History of immunodeficiency or positive HIV test
- Known or suspected viral hepatitis
- History of active tuberculosis within 1 year prior to enrollment
- Unrecovered adverse reactions from previous antitumor treatments above specified grades
- Recent chemotherapy, immunotherapy, biologic targeted treatments, or investigational products within specified timeframes before first dose
- Current use or anticipated need for strong CYP3A4/5 inhibitors or inducers
- Prior treatment with B7-H3 or PTK7 antibody-drug conjugate
- Prior topoisomerase I inhibitor treatment within 6 months before first dose
- Radiotherapy within 2 weeks prior to study entry
- Major surgery or trauma within 4 weeks prior to study entry
- Live attenuated vaccine within 28 days before first dose or expected during study
- Pregnant, lactating, or planning pregnancy during study and up to 7 months after last dose
- Known allergy to study drug components or history of severe allergic reactions to similar drugs
- Eye complications including ulcers or severe dry eye conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 20 months
Participants receive IDE034 treatment with increasing doses in Part 1 to determine safety and tolerability, followed by treatment at selected doses in Part 2 to assess safety, tolerability, and tumor response.
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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