This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
340
The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)
carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4.
carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.
cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4
Gemcitabine 1000 mg/m2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4
City of Hope
Duarte, California, United States
RECRUITINGLos Angeles Cancer Network
Glendale, California, United States
RECRUITINGCalifornia Research Institute
Los Angeles, California, United States
RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Time frame: ~2 years
Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Time frame: ~2 years
MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab
Time frame: ~2 years
Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts
The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1
Time frame: ~2 years
Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Time frame: ~2 years
To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)
Major pathological response (mPR) and pathological complete response (cPR) criteria.
Time frame: ~2 years
Area under the serum concentration time curve (AUC) of INBRX-106
Area under the serum concentration time curve (AUC) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Time frame: ~2 years
Maximum observed serum concentration (Cmax) of INBRX-106
Maximum observed serum concentration (Cmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Time frame: ~2 years
Trough observed serum concentration (Ctrough) of INBRX-106
Trough observed serum concentration (Ctrough) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Time frame: ~2 years
Time to Cmax (Tmax) of INBRX-106
Time to Cmax (Tmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Time frame: ~2 years
Immunogenicity of INBRX-106
Frequency of anti-drug antibodies (ADA) against INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Time frame: ~2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Valkyrie Clinical Trials
Murrieta, California, United States
RECRUITINGProvidence Medical Foundation
Santa Rosa, California, United States
RECRUITINGClermont Oncology Center
Clermont, Florida, United States
RECRUITINGMid Florida Hematology and Oncology Center
Orange City, Florida, United States
RECRUITINGWinship Cancer Institute - Emory University
Atlanta, Georgia, United States
RECRUITINGThe University of Chicago Medical Center
Chicago, Illinois, United States
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