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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
IDE034
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGSTART New York Long Island, LLC
Lake Success, New York, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGNEXT Texas LLC - Austin
Austin, Texas, United States
RECRUITINGSTART Dallas Fort Worth, LLC
Fort Worth, Texas, United States
RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITINGNEXT Texas LLC - Houston
Houston, Texas, United States
RECRUITINGNEXT Texas LLC - Dallas
Irving, Texas, United States
RECRUITING...and 5 more locations
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
Time frame: 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
Time frame: 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: 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: Time Frame: Approximately 20 months total study duration
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
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 1 dose escalation
Duration of Response (DoR) per RECIST v1.1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Maximum observed concentration (Cmax)
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
time to maximum observed concentration (Tmax)
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
concentration observed immediately prior to the next dose (Ctrough)
Time frame: Approximately 20 months total study duration
To evaluate immunogenicity of IDE034
Anti-IDE034 antibody incidence and titers will be determined
Time frame: Approximately 20 months total study duration
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