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LB1410

Phase 1

Solid Tumor | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Sep 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05357651A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）PHASE1 RECRUITING 100 — — Aug 12, 2022Dec 30, 2028Sep 11, 20251 China
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Study Endpoints
Primary Endpoints
Incidence and severity of treatment-emergent adverse events (TEAEs)
up to 30 days following last dose.

According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Incidence and severity of serious adverse events (SAEs)
up to 90 days following last dose.

According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

AEs of special interest (immune-related AEs)
up to 90 days following last dose.

Incidence and severity of immune-related AEs.

Incidence of DLTs
in the first 28 days (Cycle 1).

The DLT for this study is defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 and will be evaluated in the dose escalation part, the first 28 days (Cycle 1) of treatment.

Secondary Endpoints
Serum PK parameters
Up to finished treatment (each cycle is 28 days).
Overall response rate (ORR)
through study completion, an average of 8 months.
Disease control rate (DCR)
through study completion, an average of 8 months.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALUp to 9 dose cohorts will be sequentially enrolled in the dose escalation part using an accelerated titration combined with the standard 3+3 dose escalation algorithm approach.
Safety ExpansionEXPERIMENTAL2-3 doses were initially selected for safety expansion, with patients with advanced solid tumors as the main research population. Each dose cohort is expected to enroll 9-12 patients.
Exploratory ExpansionEXPERIMENTALThe Cohort Exploratory Expansion will enroll subjects by cohort at the RP2D dose, and a total of 4 cohorts (cohorts A, B, C, D) are expected.
Interventions
NameTypeDescription
LB1410DRUGanti-PD-1 and anti-TIM-3 bispecific antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Must be ≥ 18 years of age 2. For dose escalation and safety expansion phases only, patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies or lymphoma for which standard treatment fails, or no standard treatment is avail...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials
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Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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