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