An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Plain English Summary

A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types is a Phase 1 clinical trial sponsored by IDEAYA Biosciences studying 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. This study tests a new drug called IDE034 for adults with advanced or metastatic solid tumors. It is for patients whose cancer has spread and has not responded to previous treatments. Participation involves taking the study drug, IDE034, and regular medical check-ups. Standard treatments for advanced cancers are the main alternative. The trial aims to enroll 150 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with specific types of advanced solid tumors that express certain markers (B7-H3 and PTK7). Patients whose cancer has progressed after at least one prior treatment or who cannot tolerate other therapies. Individuals must have measurable disease, good general health (ECOG 0-1), and adequate organ function. Cannot have active brain metastases, recent major heart/stroke issues, uncontrolled infections, or certain lung conditions. This trial is studying 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, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will determine how safe the drug IDE034 is and if it causes any side effects, and also assess if the drug has any effect on shrinking tumors. The specific primary outcome measures are: Safety and tolerability of IDE034 in Part 1 dose escalation (21 days following the first dose of IDE034); Safety and tolerability of IDE034 in Part 2 dose expansion (Approximately 20 months total study duration); To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion (Time Frame: Approximately 20 months total study duration); To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion (Time Frame: Approximately 20 months total study duration). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a need for new treatments for advanced solid tumors that express B7-H3 and PTK7, offering a potential new option for patients with limited alternatives. This research targets 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, where improved treatment options are needed.

Investor Insight

This Phase 1 study of IDE034, targeting B7-H3 and PTK7, signals a focused effort by IDEAYA Biosciences to develop novel oncology therapeutics in a competitive landscape, with early efficacy data being Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if IDE034 is a suitable option for your specific cancer type and stage. Understand the schedule of study visits, tests, and potential side effects you might experience. Be prepared for regular blood tests, scans, and doctor's appointments throughout the study. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 150 participants

Interventions

• DRUG: IDE034 — IDE034

Primary Outcomes

• Safety and tolerability of IDE034 in Part 1 dose escalation (21 days following the first dose of IDE034)
• Safety and tolerability of IDE034 in Part 2 dose expansion (Approximately 20 months total study duration)
• To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion (Time Frame: Approximately 20 months total study duration)
• To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion (Time Frame: Approximately 20 months total study duration)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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

Trial Locations

• NEXT Texas LLC - Austin, Austin, Texas, United States
• NEXT Texas LLC - Houston, Houston, Texas, United States
• NEXT Texas LLC - Dallas, Irving, Texas, United States
• NEXT Texas LLC - San Antonio, San Antonio, Texas, United States
• NEXT Texas LLC - Virginia, Fairfax, Virginia, United States

Frequently Asked Questions

Related Conditions

• Esophageal Squamous Cell Carcinoma
• Ovarian Cancer
• Head and Neck Squamous Cell Carcinoma
• Colorectal Cancer
• Prostate Cancer
• Non-Small Cell Lung Cancer
• Endometrium Cancer
• Breast Cancer
• Solid Tumors
• Metastatic Cancer

More Esophageal Squamous Cell Carcinoma Trials

View all Esophageal Squamous Cell Carcinoma clinical trials