IDE034 for adults with advanced solid tumors that express B7-H3 and PTK7

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Sarah Cannon Research Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• AdventHealth Celebration
  Celebration, Florida, United States Recruiting
• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting

Study contacts

• Study coordinator: IDEAYA Clinical Trials
• Email: IDEAYAClinicalTrials@ideayabio.com
• Phone: 1-855-433-2246

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-in-human test of HH160 in people with advanced solid tumors

  HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.

  Recruiting at 3 sites Phase 1 Huahui Health · Waratah, New South Wales and 2 other locations · NCT07623369

• Testing ZM008 alone and with Pembrolizumab in patients with advanced solid tumors

  This study is testing a new treatment called ZM008, alone and with another drug called Pembrolizumab, to see if it can help patients with advanced solid tumors who have run out of other treatment options.

  Recruiting at 3 sites Phase 1 Zumutor Biologics Inc. · Boston, Massachusetts and 2 other locations · NCT06451497

• Testing NEO212 for treating certain brain tumors and metastases

  This study is testing a new treatment called NEO212 for people with certain types of brain tumors to see if it is safe and effective when combined with standard treatments.

  Recruiting at 8 sites Phase 1/2 Neonc Technologies, Inc. · Beverly Hills, California and 7 other locations · NCT06047379

• Assessing the safety and effects of Azirkitug in cancer patients

  This study is testing a new cancer drug called Azirkitug to see how safe it is and how well it works for adults with certain types of lung and head and neck cancers.

  Recruiting at 47 sites Phase 1 AbbVie · Duarte, California and 47 other locations · NCT05005403

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• IBI3028 in advanced solid tumors

  This phase 1 study tests IBI3028 in adults with unresectable or metastatic solid tumors to see if it is safe and how patients tolerate it.

  Recruiting Phase 1 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Tianjin, Tianjin Municipality · NCT07589205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.