A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
NCT Number: NCT06468358
Acronym: TRIGGERCD8
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor
Interventions: DRUG: LB1410|DRUG: LB4330
Sponsor: L & L biopharma Co., Ltd., Shanghai China
Collaborators: Shanghai East Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 194
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2027-12-30
Locations: Shanghai East Hospital, Shanghai, Shanghai, 201114, China

Summary:
This is a phase Ib/II, open, dose-escalation and expansion study of an anti-PD1/TIM3 bispecific antibody，LB1410 in combination with an anti-Claudin18.2/IL-10 fusion protein, LB4330 in patients with advanced or metastatic solid tumors.

Primary Outcome Measures: Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0), Incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events reported per NCI-CTCAE v5.0, up to 60 days following last dose|Incidence and severity of serious adverse events (SAEs) and other special interest (immune-related AEs), According to NCI-CTCAE v5.0, up to 60 days following last dose|Incidence of Dose limiting toxicity (DLT), The DLT for this study is defined per CTCAE 5.0 and will be evaluated in the Cycle 1 of treatment in the dose escalation part. If dosing delay occurs, the DLT evaluation should be correspondingly extended to 14 days after the second dosing., At the end of Cycle 1 (each cycle is 28 days)|Maximum tolerance toxicity (MTD) and recommended dose for Phase II (RP2D) definition, MTD and RP2D based on the safety data collected during the dose escalation phase (Phase I), up to 1 year|Overall response rate (ORR), Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the total number of evaluable patients, From first participant until last participant assessment, an average of 8 months|Disease control rate (DCR), Percentage of patients whose best overall response is either a Complete Response, a Partial Response or Stable Disease according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the total number of evaluable patients., From first participant until last participant assessment, an average of 8 months|Duration of overall Response (DoR) by RECIST version 1.1, Time from the date of first documented response (CR or PR) to the date of first documented disease progression according to RECIST 1.1 criteria or the date of death due to underlying cancer., From first participant until last participant assessment, an average of 8 months|Progression Free Survival (PFS) by RECIST version 1.1, Time from the first infusion of LB1410 and LB4330 to the date of first documented tumor progression according to RECIST 1.1 criteria or death due to any cause, whichever occurs first over evaluable patients., From first participant until last participant assessment, an average of 8 months|DDC, Time from the date of first documented CR, PR or SD to the date of first documented disease progression according to RECIST 1.1 criteria or the date of death due to any cause., From first participant until last participant assessment, an average of 8 months|Overall Survival (OS) duration, Time from first LB1410 and LB4330 infusion to the date of death due to any cause over evaluable patients., From first participant until last participant assessment, an average of 1 year
Secondary Outcome Measures: Pharmacokinetics of LB1410 and LB4330: Maximum plasma concentration of the study drug (Cmax), Maximum observed plasma concentration of the study drug, Through study completion, an average of 1 year|Pharmacokinetics of LB1410 and LB4330: Area Under the concentration-time curve (AUC), Area under the plasma concentration-time curve, Through study completion, an average of 1 year|Pharmacokinetics of LB1410 and LB4330: Clearance, A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time, Through study completion, an average of 1 year|Pharmacokinetics of LB1410 and LB4330: Terminal elimination half-life ( T½), Terminal elimination half life, Through study completion, an average of 1 year|Evaluation of immunogenicity of each antibody drug in the combinations, Occurrence of anti-drug antibody (ADA) measured in serum at selected time points during the study, Up to 60 days following last dose