The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administered IV
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
St Vincent's Hospital
Sydney, New South Wales, Australia
Universitair Ziekenhuis Gent
Ghent, Belgium
Institut Claudius Regaud - IUCT Oncopole
Toulouse, France
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator.
Time frame: Baseline through Cycle 1 (Up to 42 Day Cycle)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172
PK: Cmin of LY3434172
Time frame: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; Cycle 1 Day 15 (C1D15): Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion
PK: Maximum Concentration (Cmax) of LY3434172
PK: Cmax of LY3434172
Time frame: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion
PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172
PK: AUC 0-tlast of LY3434172
Time frame: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
ORR: Percentage of participants who have received any amount of study drug, have at least one postbaseline tumor image, and achieved a best overall response (BOR) of confirmed Complete Response (CR) is defined a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Asan Medical Center
Songpa-gu, Seoul, South Korea
Time frame: Baseline through Measured Progressive Disease (Up to 8.4 Months)
Duration of Response (DOR)
DOR is defined only for responders (participants with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of the first observed radiographically documented progressive disease (PD), or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment.
Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 8.4 Months)
Time to Response (TTR)
TTR is defined as the time from the date of first study treatment until the first evidence of confirmed CR or PR.
Time frame: Baseline to Date of CR or PR (Up to 8.4 Months)
Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR
Disease control rate is defined as the number of participants with SD, confirmed PR, or confirmed CR (CR+PR+SD) divided by the number of enrolled participants who have received any quantity of study treatment.
Time frame: Baseline through Measured Progressive Disease (Up to 8.4 Months)