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

Study Identifier:
IDE034-001
CT.gov Identifier:
NCT07503808
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

To characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Esophageal
Ovarian
Head & Neck
Bowel (Colorectal)
Unmapped
Non-Small Cell Lung Cancer
Endometrial
Breast Cancers
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1:IDE034 Dose Escalation
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Drug: 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: Drug: IDE034
Drug: IDE034
Drug: EXPERIMENTAL: Part 2: IDE034 Dose Expansion
Drug: 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
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Recruiting
Condition(s) Treated at Site
Esophageal
Ovarian
Head & Neck
Bowel (Colorectal)
Unmapped
Non-Small Cell Lung Cancer
Endometrial
Breast Cancers
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Will Be Recruiting
Condition(s) Treated at Site
Esophageal
Ovarian
Head & Neck
Bowel (Colorectal)
Unmapped
Non-Small Cell Lung Cancer
Endometrial
Breast Cancers
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Bruno Fang
Status
Will Be Recruiting
Condition(s) Treated at Site
Esophageal
Ovarian
Head & Neck
Bowel (Colorectal)
Unmapped
Non-Small Cell Lung Cancer
Endometrial
Breast Cancers
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Esophageal
Ovarian
Head & Neck
Bowel (Colorectal)
Unmapped
Non-Small Cell Lung Cancer
Endometrial
Breast Cancers
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Will Be Recruiting
Condition(s) Treated at Site
Esophageal
Ovarian
Head & Neck
Bowel (Colorectal)
Unmapped
Non-Small Cell Lung Cancer
Endometrial
Breast Cancers