An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
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.
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.
Arms & interventions
- DrugIDE034
IDE034
Outcome measures
Primary
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
Secondary
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time frame: Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents:
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
Pharmacokinetics (PK) of IDE034 and its constituents
Time frame: Approximately 20 months total study duration
To evaluate immunogenicity of IDE034
Time frame: Approximately 20 months total study duration
Eligibility criteria
Study locations (15)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Florida Cancer Specialists
Sarasota, Florida, 34232
Karmanos Cancer Institute
Detroit, Michigan, 48201
START New York Long Island, LLC
Lake Success, New York, 11042
SCRI Oncology Partners
Nashville, Tennessee, 37203
NEXT Texas LLC - Austin
Austin, Texas, 78758
START Dallas Fort Worth, LLC
Fort Worth, Texas, 76104
MD Anderson
Houston, Texas, 77030
NEXT Texas LLC - Houston
Houston, Texas, 77054
NEXT Texas LLC - Dallas
Irving, Texas, 75039
NEXT Texas LLC - San Antonio
San Antonio, Texas, 78229
START San Antonio, LLC
San Antonio, Texas, 78229
START Mountain Region, LLC
West Valley City, Utah, 84119
NEXT Texas LLC - Virginia
Fairfax, Virginia, 22031
Medical Oncology Associates
Spokane, Washington, 99208