IDE034 for adults with advanced solid tumors that express B7-H3 and PTK7
An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
This trial will test IDE034 to see if it is safe and works in adults with advanced or metastatic solid tumors that express B7-H3 and PTK7.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IDEAYA Biosciences Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 5 sites (Austin, Texas and 4 other locations) |
| Trial ID | NCT07503808 on ClinicalTrials.gov |
What this trial studies
This Phase 1a/1b, open-label, multicenter trial uses a dose-escalation and dose-expansion design to test the safety, pharmacokinetics, immunogenicity, and early anti-tumor activity of IDE034 in adults with locally advanced or metastatic solid tumors that express B7-H3 and PTK7. Part 1 will escalate doses to define dose-limiting toxicities, the maximum tolerated dose, and a recommended dose for expansion. Part 2 will enroll expansion cohorts at two or more safe dose levels to look for tumor responses and may open a basket cohort based on emerging nonclinical and early clinical data. Archival tumor tissue and measurable disease are required, and participants must have ECOG 0–1 and adequate organ function.
Who should consider this trial
Good fit: Adults (≥18) with locally advanced or metastatic solid tumors that test positive for B7-H3 and PTK7, measurable disease, ECOG 0–1, adequate organ function, and prior progression on or intolerance to at least one standard therapy are the intended candidates.
Not a fit: Patients whose tumors do not express B7-H3/PTK7, who have symptomatic brain metastases, poor organ function, or recent other malignancies are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, IDE034 could shrink tumors or slow disease progression in patients whose cancers express B7-H3 and PTK7, offering a new targeted treatment option.
How similar studies have performed: Other early-phase trials targeting B7-H3 or PTK7 have shown limited signals of activity but these targets remain investigational and the approach is still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
9. Participants with known or suspected viral hepatitis
10. Have history of active tuberculosis within 1 year before enrollment
11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms
12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP
13. Administration of any of the following
1. Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).
3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP
4. Have received radiotherapy within 2 weeks prior to study entry
5. Have undergone major surgery or trauma within 4 weeks prior to study entry.
6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.
7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.
8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody/fusion protein drugs.
9. Participants with complications in the eye including ulcers in the eye, and severe dry eye
Where this trial is running
Austin, Texas and 4 other locations
- NEXT Texas LLC - Austin — Austin, Texas, United States (Recruiting)
- NEXT Texas LLC - Houston — Houston, Texas, United States (Recruiting)
- NEXT Texas LLC - Dallas — Irving, Texas, United States (Recruiting)
- NEXT Texas LLC - San Antonio — San Antonio, Texas, United States (Recruiting)
- NEXT Texas LLC - Virginia — Fairfax, Virginia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.