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

NCT07503808 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IDE034-001IND 178016
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief 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.

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; 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

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Time Frame: Approximately 20 months total study duration

Secondary Outcomes (12)

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

  Approximately 20 months total study duration

• 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 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

Study Arms (2)

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

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

Drug: IDE034

Interventions

IDE034 DRUG

IDE034

Part 1:IDE034 Dose Escalation; Part 2: IDE034 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• IDEAYA Biosciences: lead

Study Sites (5)

NEXT Texas LLC - Austin

Austin, Texas, 78758, 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

NEXT Texas LLC - Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Endometrial Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 31, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)