Phase 1/2a Phase 1 is an open-label, multicenter dose escalation/dose expansion study designed to assess the safety, tolerability, pharmacokinetics (PK) and antitumor activity of IMX-110 in combination with Tislelizumab. The recommended Phase 2 dose (RP2D) will be evaluated in further dose expansion Phase 2a study submitted as an amendment to this Phase 1 protocol during the conduct of the Phase 1 study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors
CIP Centro Integrado de Pesquisa / Hospital de Base / Fundação Faculdade de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
RECRUITINGInstituto do Cancer do Estado de São Paulo (ICESP)
São Paulo, São Paulo, Brazil
RECRUITINGNumber of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Incidence, severity and causality of AE and serious adverse events (SAE) / Physical examination changes from baseline / Vital sign changes from baseline (heart rate, systolic/diastolic blood pressure, respiratory rate, and temperature) / Hematology and chemistry parameter changes from baseline / 12-lead ECG and 2-D Echocardiogram changes from baseline
Time frame: 28 days
Maximum tolerated doses (MTDs) and RP2D of IMX-110 in combination with Tislelizumab
MTD is defined as the highest dose at which ≤ 33% of the patients treated during the 3+3 design experience a DLT and/or at least two ≥ grade 2 non-hematologic toxicities during the first treatment cycle, and will be used to identify the RP2D to be taken forward to Phase 2a.
Time frame: 28 days
Plasma concentrations of IMX-110
Plasma concentration of IMX-110 will be measured when administered in treatment Cycle 1. Samples will be collected on Day 1 (pre-dose, and immediately after, 5 minutes, 1 hour, 1.5 hours, 3 hours, 5 hours post-dose), on Day 2 (pre-dose), and Day 5 (pre-dose and immediately after, 5 minutes, 1 hour, 1.5 hours, 3 hours, 5 hours post-dose), and optionally on Day 7 (pre-dose, 5 minutes, 15 minutes, 1 hour, 1.5 hours, 3 hours, 5 hours post-dose).
Time frame: 7 days
Response Rate
Objective Response Rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and iRECIST
Time frame: 8 weeks
Progression-free survival (PFS)
PFS is measured from the start of treatment to the time of progression or death, whichever occurs first while on the study.
Time frame: 5 years
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Overall Survival (OS)
OS is defined as the time from Cycle 1 Day1 to death due to any cause.
Time frame: 5 years
Duration of Response (DOR)
DOR as determined by RECIST criteria version 1.1 and iRECIST
Time frame: 5 years