The purpose of this study is to assess safety, tolerability, and preliminary activity of LB101 monotherapy in participants with advanced solid tumors.
This study consists of 2 parts: First in Human (FIH) dose escalation and dose optimization (Part 1a and Part 1b, respectively) and dose expansion (Part 2). Part 1 will evaluate LB101 monotherapy in participants with selected, advanced solid tumors and determine the Recommended Dose(s) for Expansion (RDE(s)) for Part 2. The design of Part 2 depends on the results of Part 1 and will further evaluate the safety, efficacy, tolerability, pharmacokinetics, and immune response of LB101.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Part 1: IV infusion of LB101 Q2W (28-day cycle) and Part 2: IV infusion of LB101
Sarah Cannon Research Institute at HealthONE.
Denver, Colorado, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Sarasota, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute at Tennessee Oncology Nashville
Nashville, Tennessee, United States
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) as graded according to the NCI CTCAE v5.0
Time frame: 28 days following the first dose of LB101 (Days 1 to 28 of Cycle 1)
Part 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as defined as events that started or worsened after first dose of study intervention until 30 days after last dose
Time frame: From start of study treatment up to 3 years
Part 1: Number of Participants with Recommended Dose(s) for Expansion
Recommended Dose for expansion will be determined.
Time frame: 28 days following the first dose of LB101 (Days 1 to 28 of Cycle 1)
Part 2: Proportion of Participants with Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Evaluated by the Blinded Independent Central Review (BICR)
Time frame: Up to 3 years
Part 1 and 2: Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator
Time frame: Up to 3 years
Part 1 and 2: Duration of Response (DoR) According to RECIST v1.1 Evaluated by the Blinded Independent Central Review (BICR)
Time frame: Time from first objective response to first occurrence of objective tumor progression or death from any cause (up to 3 years)
Part 1 and 2: Proportion of Participants with Disease Control Rate (DCR) According to RECIST v1.1 Evaluated by the Blinded Independent Central Review (BICR)
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NEXT Oncology - Dallas
Irving, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Institut Gustave Roussy
Villejuif, France
Part 1 and 2: Duration of Response (DoR) Assessed by Investigator
Time frame: Time from first objective response to first occurrence of objective tumor progression or death from any cause (up to 3 years)
Part 1 and 2: Disease Control Rate (DCR) Assessed by Investigator
Time frame: Up to 3 years
Part 1 and 2: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to LB101
Time frame: Up to 3 years
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Maximum (peak) Concentration (Cmax) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Maximum (peak) Concentration (Cmax) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Time to Maximum Observed Concentration (Tmax) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Time to Maximum Observed Concentration (Tmax) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Area Under the Concentration-time Curve at 14 days Post Drug Administration (AUC14days) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11), Cycle 2 (Day 1, 2, and 8), Cycle 3 (Day 1), and Cycle 4 (Day 1)
Part 2: Area Under the Concentration-time Curve at 14 days Post Drug Administration (AUC14days) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1), Cycle 2 (Day 1), and Cycle 3 (Day 1)
Part 1: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-last) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-last) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Elimination Half-life (t1/2) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Elimination Half-life (t1/2) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Elimination Rate Constant (Kel) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Elimination Rate Constant (Kel) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Apparent Total Body Clearance (CL/F) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Apparent Total Body Clearance (CL/F) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Apparent Volume of Distribution (Vd/F) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Apparent Volume of Distribution (Vd/F) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)
Part 1: Predose Trough Concentrations (CTrough) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 2, 3, 5, 8, 11, 15, 16, and 22), Cycle 2 (Day 1, 2, 8, and 15), Cycle 3 (Day 1, and 15), and Cycle 4 (Day 1, and 15)
Part 2: Predose Trough Concentrations (CTrough) of LB101
Time frame: Day 0 (pre-dose) and at multiple time points (up to End of infusion) post-dose in Cycle 1 (Day 1, 15, 16, and 22), Cycle 2 (Day 1, and 15), and Cycle 3 (Day 1, and 15)