Clinical trialPhase 1 / Phase 2Recruiting
A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
A Phase Ib/II, Open, Dose-escalation and Expansion Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 19 June 2024
- Expected end
- 30 December 2027
- Enrollment
- 194 participants
- Sites
- 1
- Primary outcomes
- Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0); Incidence and severity of serious adverse events (SAEs) and other special interest (immune-related AEs); Incidence of Dose limiting toxicity (DLT); Maximum tolerance toxicity (MTD) and recommended dose for Phase II (RP2D) definition; Overall response rate (ORR)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 11 September 2025
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
The phase Ib/II clinical study in Chinese patients with advanced or metastatic solid tumors to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD), anti-tumor efficacy, and biomarkers of LB1410 in combination with LB4330. The study will include 2 parts: dose escalation (Phase Ib) and dose expansion (Phase II). Repeated intravenous infusion of LB1410 in combination with LB4330 in patients with metastatic or advanced pancreatic ductal adenocarcinoma, cholangiocarcinoma, colorectal cancer, ovarian, fallopian tube, or primary peritoneal cancer, non-small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma, renal cell carcinoma, cervical squamous cell carcinoma, and endometrial carcinoma.