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IDE034

Phase 1

Esophageal Squamous Cell Carcinoma | Small molecule | Oncology |IDEAYA Biosciences, Inc.|Last Updated: Jun 18, 2026

Target and mechanism

Molecular targetB7H3, PTK7
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

IDE034 · 1 trial · 8 indications

Phase 1 1
NCT07503808A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors TypesEsophageal Squamous Cell Carcinoma
RECRUITING150 Analytics
PHASE1RECRUITING
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
Esophageal Squamous Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of IDE034 in Part 1 dose escalation
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
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: Approximately 20 months total study duration

Objective Response Rate (ORR) per RECIST v1.1

Secondary Endpoints

To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Approximately 20 months total study duration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1:IDE034 Dose EscalationEXPERIMENTALIDE034 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 ExpansionEXPERIMENTALIDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation

Interventions

NameTypeDescription
IDE034DRUGIDE034
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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 r...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJun 18, 2026NCT07503808lastUpdatePostDate: changed
LOWJun 18, 2026NCT07503808lastUpdatePostDate: changed
LOWJun 18, 2026NCT07503808lastUpdatePostDate: changed

Frequently asked questions about IDE034

What is IDE034 used for?

IDE034 is an investigational small molecule being studied for the treatment of esophageal squamous cell carcinoma. It is also being evaluated in other solid tumor types including high grade serous ovarian cancer, head and neck squamous cell carcinoma, colorectal cancer, castration-resistant prostate cancer, non small cell lung cancer, endometrium cancer, and triple negative breast cancer.

What does IDE034 target?

IDE034 targets the proteins B7H3 and PTK7. These are the molecular targets of the investigational drug, which is being developed as a small molecule therapeutic for oncology indications.

Who makes IDE034?

IDE034 is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IDYA on the stock market.

What phase is IDE034 in?

IDE034 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities and is currently being studied in a Phase 1 clinical trial.

What clinical trials is IDE034 in?

IDE034 is being studied in a Phase 1 clinical trial with the identifier NCT07503808. This trial is recruiting adult participants with locally advanced or metastatic solid tumors, including esophageal squamous cell carcinoma, and is being conducted in the United States.

Is IDE034 the same as B7H3 or PTK7?

No, IDE034 is not the same as B7H3 or PTK7. B7H3 and PTK7 are the molecular targets of IDE034, meaning the drug is designed to interact with these proteins. IDE034 is a distinct investigational compound being developed to target these proteins in cancer treatment.