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RecruitingNCT07503808Updated Jun 18, 2026

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

A Phase 1 interventional study of IDE034 in Esophageal Squamous Cell Carcinoma, High Grade Serous Ovarian Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by IDEAYA Biosciences. Recruiting at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by IDEAYA Biosciences · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Part 1 - Dose escalation Part 1 will evaluate increasing doses of IDE034 to assess safety, tolerability, and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in subjects with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.

Part 2 - Dose Expansion Part 2 will evaluate participants with B7-H3 and PTK7 expressing advanced/metastatic solid tumors at 2 or more dose levels determined to be safe and tolerable during dose escalation. The goal of Part 2 is to identify which of the doses evaluated in Part 1 is safe, well tolerated and results in tumor responses.

In parallel a basket cohort may be enrolled at one of the expansion dose(s) for which the tumor types and other selection criteria will be based on emerging data from nonclinical and Part 1 clinical evaluations. Additional selection criteria may be applied to the expansion indications (e.g., histological subset or select molecular alterations) based on emerging data.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
  • High Grade Serous Ovarian Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Colorectal Cancer
  • Castration-resistant Prostate Cancer
  • Non Small Cell Lung Cancer
  • Endometrium Cancer
  • Triple Negative Breast Cancer

Keywords

  • Esophageal Squamous Cell Carcinoma
  • ESCC
  • Endometrial Cancer
  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Triple-negative Breast Cancer
  • TNBC
  • Colorectal Cancer
  • CRC
  • Castration-resistant Prostate Cancer
  • CRPC
  • Non-small Cell Lung Cancer
  • NSCLC
  • High-grade Serous Ovarian Cancer
  • HGSOC
  • Advanced, Metastic Solid Tumors
  • B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)
  • IDE034
03

In context

Esophageal Squamous Cell Carcinoma

645 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.

This study's planned enrollment of 150 is above the median of 65 across 539 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

IDEAYA Biosciences is the lead sponsor of 11 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Part 1:IDE034 Dose Escalation

    IDE034 Dose Escalation Successive cohorts of participants will be treated with increasing doses of IDE034 until the maximum tolerated dose or the recommended dose for expansion is determined

    Drug: IDE034

  • Experimental
    Part 2: IDE034 Dose Expansion

    IDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation

    Drug: IDE034

Interventions

  • DrugIDE034

    IDE034

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of IDE034 in Part 1 dose escalation

    Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0

    Time frame: 21 days following the first dose of IDE034

  2. Safety and tolerability of IDE034 in Part 2 dose expansion

    Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0

    Time frame: Approximately 20 months total study duration

  3. To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion

    Objective Response Rate (ORR) per RECIST v1.1

    Time frame: Time Frame: Approximately 20 months total study duration

  4. To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion

    Duration of Response (DoR) per RECIST v1.1

    Time frame: Time Frame: Approximately 20 months total study duration

Secondary outcomes

  1. To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation

    Objective Response Rate (ORR) per RECIST v1.1

    Time frame: Approximately 20 months total study duration

  2. To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation

    Duration of Response (DoR) per RECIST v1.1

    Time frame: Approximately 20 months total study duration

  3. To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation

    Disease Control Rate (DCR) per RECIST v1.1

    Time frame: Approximately 20 months total study duration

  4. To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation

    Duration of response per RECIST v1.1

    Time frame: Approximately 20 months total study duration

  5. To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion

    Disease Control Rate (DCR) per RECIST v1.1

    Time frame: Approximately 20 months total study duration

  6. To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion

    Duration of response per RECIST v1.1

    Time frame: Approximately 20 months total study duration

  7. Pharmacokinetics (PK) of IDE034 and its constituents:

    Area under concentration time curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: Approximately 20 months total study duration

  8. Pharmacokinetics (PK) of IDE034 and its constituents

    Area under concentration time curve from time 0 to the end of dosing interval (AUCtau)

    Time frame: Approximately 20 months total study duration

  9. Pharmacokinetics (PK) of IDE034 and its constituents

    Maximum observed concentration (Cmax)

    Time frame: Approximately 20 months total study duration

  10. Pharmacokinetics (PK) of IDE034 and its constituents

    time to maximum observed concentration (Tmax)

    Time frame: Approximately 20 months total study duration

  11. Pharmacokinetics (PK) of IDE034 and its constituents

    concentration observed immediately prior to the next dose (Ctrough)

    Time frame: Approximately 20 months total study duration

  12. To evaluate immunogenicity of IDE034

    Anti-IDE034 antibody incidence and titers will be determined

    Time frame: Approximately 20 months total study duration

07

Study locations

15 of 15 sites recruiting
  • Sarah Cannon Research Institute at HealthONE
    Denver, Colorado 80218, United States
    Recruiting
  • Florida Cancer Specialists
    Sarasota, Florida 34232, United States
    Recruiting
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
    Recruiting
  • START New York Long Island, LLC
    Lake Success, New York 11042, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
    Recruiting
  • NEXT Texas LLC - Austin
    Austin, Texas 78758, United States
    Recruiting
  • START Dallas Fort Worth, LLC
    Fort Worth, Texas 76104, United States
    Recruiting
  • MD Anderson
    Houston, Texas 77030, United States
    Recruiting
  • NEXT Texas LLC - Houston
    Houston, Texas 77054, United States
    Recruiting
  • NEXT Texas LLC - Dallas
    Irving, Texas 75039, United States
    Recruiting
  • NEXT Texas LLC - San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
  • START San Antonio, LLC
    San Antonio, Texas 78229, United States
    Recruiting
  • START Mountain Region, LLC
    West Valley City, Utah 84119, United States
    Recruiting
  • NEXT Texas LLC - Virginia
    Fairfax, Virginia 22031, United States
    Recruiting
  • Medical Oncology Associates
    Spokane, Washington 99208, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07503808
Lead sponsor
IDEAYA Biosciences
Responsible party
Sponsor
First posted
Mar 31, 2026
Start date
Feb 24, 2026
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

IDEAYA Clinical Trials
Contact
IDEAYAClinicalTrials@ideayabio.com
1-855-433-2246

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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