Esophageal Squamous Cell CarcinomaPhase 1NCT07503808
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
A Phase 1 study testing IDE034 in people with Esophageal Squamous Cell Carcinoma and High Grade Serous Ovarian Cancer, run by IDEAYA Biosciences at 15 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, High Grade Serous Ovarian Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- IDE034
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesUnited States
- Study dates
- 24 Feb 2026to 30 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be at least 18 years of age or the age of maturity per local regulations
- 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.
- Archival tissue sample for testing
- Measurable disease
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Have adequate bone marrow and organ function.
- Able to comply with contraceptive/barrier requirements
Who cannot join
- Known symptomatic brain metastases or leptomeningeal metastasis
- Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.
- Have uncontrolled tumor-associated pain
- Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose
- Active uncontrolled infection
- 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.
Show all 22Show fewer
- 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.
- Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.
- Participants with known or suspected viral hepatitis
- Have history of active tuberculosis within 1 year before enrollment
- 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
- 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
- Administration of any of the following
- Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
- Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).
- Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP
- Have received radiotherapy within 2 weeks prior to study entry
- Have undergone major surgery or trauma within 4 weeks prior to study entry.
- 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.
- Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.
- 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.
- Participants with complications in the eye including ulcers in the eye, and severe dry eye
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
NEXT Texas LLC - Austin
Austin, Texas, 78758
Sheena Sahota, 737-610-5200, ssahota@nextoncology.com
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Gerald Falchook, (615) 329-7274, SCRI.Webmaster@scri.com
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
cancercareSCRI@usoncology.com Saif, 1-800-527-6266, giving@karmanos.org
- Recruiting
NEXT Texas LLC - Virginia
Fairfax, Virginia, 22031
Alexander Spira, 703-783-4510, aspira@nextoncology.com
- Recruiting
START Dallas Fort Worth, LLC
Fort Worth, Texas, 76104
Henry Xiong, 682-350-3010, info@startresearch.com
- Recruiting
MD Anderson
Houston, Texas, 77030
Timothy Yap, 1-866-918-1601, tyap@mdanderson.org
- Recruiting
NEXT Texas LLC - Houston
Houston, Texas, 77054
Jennifer Segar, 832-384-7900, jsegar@nextoncology.com
- Recruiting
NEXT Texas LLC - Dallas
Irving, Texas, 75039
Michael Song, 972-893-8800, msong@nextoncology.com
- Recruiting
START New York Long Island, LLC
Lake Success, New York, 11042
Geraldine O'Sullivan Coyne, 363-207-5160, info@startresearch.com
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Deepak Bhamidipati, 615-329-7640, cancercareSCRI@usoncology.com
- Recruiting
NEXT Texas LLC - San Antonio
San Antonio, Texas, 78229
Dr. Sommerhalder, 210-580-9500, dsommerhalder@nextoncology.com
- Recruiting
START San Antonio, LLC
San Antonio, Texas, 78229
Kyriakos Papadopoulos, 210-593-5250, info@startresearch.com
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Manish Patel, (941) 377-9993, scheduling@partnersimage.com
- Recruiting
Medical Oncology Associates
Spokane, Washington, 99208
Arvind Chaudhry, 5094622273, arvind.chaudhry@aoncology.com
- Recruiting
START Mountain Region, LLC
West Valley City, Utah, 84119
Jose Pacheco, 801-907-4750, info@startresearch.com
About this study
Official title: An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
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.
- Conditions
- 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
- Being tested
- IDE034
- 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
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDE034Drug
IDE034
| Study group | Role | What they receive |
|---|---|---|
| Part 1:IDE034 Dose Escalation | Experimental | 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 Receives: Drug: IDE034 |
| Part 2: IDE034 Dose Expansion | Experimental | 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 Receives: Drug: IDE034 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days following the first dose of IDE034
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
Measured: Approximately 20 months total study duration
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Objective Response Rate (ORR) per RECIST v1.1
Measured: Time Frame: Approximately 20 months total study duration
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Duration of Response (DoR) per RECIST v1.1
Measured: Time Frame: Approximately 20 months total study duration
Secondary outcomes (12)
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Objective Response Rate (ORR) per RECIST v1.1
Measured: Approximately 20 months total study duration
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Duration of Response (DoR) per RECIST v1.1
Measured: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Disease Control Rate (DCR) per RECIST v1.1
Measured: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Duration of response per RECIST v1.1
Measured: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Disease Control Rate (DCR) per RECIST v1.1
Measured: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Duration of response per RECIST v1.1
Measured: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents:
Area under concentration time curve from time 0 to the last quantifiable concentration (AUClast)
Measured: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Area under concentration time curve from time 0 to the end of dosing interval (AUCtau)
Measured: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Maximum observed concentration (Cmax)
Measured: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
time to maximum observed concentration (Tmax)
Measured: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
concentration observed immediately prior to the next dose (Ctrough)
Measured: Approximately 20 months total study duration
To evaluate immunogenicity of IDE034
Anti-IDE034 antibody incidence and titers will be determined
Measured: Approximately 20 months total study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start24 Feb 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IDEAYA BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDEAYA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503808
- Sponsor's protocol ID
- IDE034-001
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07503808
- Acronym / sponsor ID
- IDE034-001
- Conditions
- 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
- Keywords
- Esophageal Squamous Cell Carcinoma, ESCC, Endometrial Cancer, Head and Neck Squamous Cell Carcinoma, HNSCC, Triple-negative Breast Cancer, TNBC, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IDEAYA BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1:IDE034 Dose Escalation | Experimental | Drug: IDE034IDE034 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 |
| Part 2: IDE034 Dose Expansion | Experimental | Drug: IDE034IDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be at least 18 years of age or the age of maturity per local regulations
- 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.
- Archival tissue sample for testing
- Measurable disease
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Key exclusion criteria (22 listed)
- Known symptomatic brain metastases or leptomeningeal metastasis
- Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.
- Have uncontrolled tumor-associated pain
- Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose
- Active uncontrolled infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDE034IDE034 | Drug | Part 1:IDE034 Dose Escalation, Part 2: IDE034 Dose Expansion |
Primary outcome
Safety and tolerability of IDE034 in Part 1 dose escalation
Time frame: 21 days following the first dose of IDE034
Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0
Safety and tolerability of IDE034 in Part 2 dose expansion
Time frame: Approximately 20 months total study duration
Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time frame: Time Frame: Approximately 20 months total study duration
Objective Response Rate (ORR) per RECIST v1.1
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time frame: Time Frame: Approximately 20 months total study duration
Duration of Response (DoR) per RECIST v1.1
12 secondary outcomes
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents:
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
To evaluate immunogenicity of IDE034
Time frame: Approximately 20 months total study duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDE034 in people with Esophageal Squamous Cell Carcinoma and High Grade Serous Ovarian Cancer, run by IDEAYA Biosciences at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IDEAYA Clinical Trials (1-855-433-2246, IDEAYAClinicalTrials@ideayabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of IDE034 in Part 1 dose escalation (time frame: 21 days following the first dose of IDE034). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.