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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Non Small Cell Lung Cancer; Triple Negative Breast Cancer; Castration-resistant Prostate Cancer; Head and Neck Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma; High Grade Serous Ovarian Cancer; Endometrium Cancer
• Intervention / Treatment: Drug: IDE034

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • Recruiting
      • NEXT Texas LLC - Austin
      • Contact: Sheena Sahota; Phone Number: 737-610-5200; Email: ssahota@nextoncology.com
    • Houston, Texas, United States, 77054
      • Recruiting
      • NEXT Texas LLC - Houston
      • Contact: Jennifer Segar; Phone Number: 832-384-7900; Email: jsegar@nextoncology.com
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Texas LLC - Dallas
      • Contact: Michael Song; Phone Number: 972-893-8800; Email: msong@nextoncology.com
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Texas LLC - San Antonio
      • Contact: Dr. Sommerhalder; Phone Number: 210-580-9500; Email: dsommerhalder@nextoncology.com
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Texas LLC - Virginia
      • Contact: Alexander Spira; Phone Number: 703-783-4510; Email: aspira@nextoncology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; IDE034

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation	Objective Response Rate (ORR) per RECIST v1.1	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	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	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	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	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	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)	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)	Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents	Maximum observed concentration (Cmax)	Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents	time to maximum observed concentration (Tmax)	Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents	concentration observed immediately prior to the next dose (Ctrough)	Approximately 20 months total study duration
To evaluate immunogenicity of IDE034	Anti-IDE034 antibody incidence and titers will be determined	Approximately 20 months total study duration

Collaborators and Investigators

• Sponsor: IDEAYA Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Triple-negative Breast Cancer; Colorectal Cancer; TNBC; HNSCC; Endometrial Cancer; Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma; ESCC; CRC; CRPC; Castration-resistant Prostate Cancer; HGSOC; High-grade Serous Ovarian Cancer; Advanced, Metastic Solid Tumors; B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7); IDE034
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Esophageal Diseases; Lung Neoplasms; Genital Neoplasms, Female; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Bronchogenic; Bronchial Neoplasms; Uterine Neoplasms; Carcinoma, Squamous Cell; Esophageal Neoplasms; Breast Neoplasms; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: IDE034-001; IND 178016 (Other Identifier: Regulatory Agency Identifier Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No