A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors

A First-in-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of Claudin18.2 (CLDN18.2)-Directed Antibody-Drug Conjugate (ADC) LCB02A in Patients With CLDN18.2-positive Advanced Solid Tumors

This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory to standard of care therapy or for whom no standard of care options are available. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of single agent LCB02A is determined, the study will proceed to Phase 2 expansion cohorts in selected tumor types.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: LCB02A

• Study Type: Interventional
• Enrollment (Estimated): 191
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: David Browning; Phone Number: +1-615-975-7776; Email: clinicaltrials@ligachembio.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 3H2
      • Princess Margaret Hospital
      • Principal Investigator: Elena Elimova, MD
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
    • Principal Investigator: Do-Youn Oh, MD
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
      • Principal Investigator: Haeseong Park, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina
      • Principal Investigator: A. Craig Lockhart, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment.
• Phase 2 Dose Expansion: selected histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment. Expansion cohort indications will be prioritized based on data from the Phase 1 dose escalation portion.
• Prior treatment with Claudin 18.2 directed therapy is permitted.
• Measurable disease as defined by RECIST v1.1
• Willingness to provide archival tumor tissue when available, or to undergo a pre-treatment biopsy if archival tissue is not available.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Adequate organ function as defined by:

  • Absolute neutrophil count ≥ 1.5 × 109/L , without colony stimulating factor support for the past 14 days
  • Platelet count ≥ 100 × 109/L
  • Hemoglobin level ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5× upper limit of normal (ULN) or <3 x ULN with Gilbert's syndrome or liver metastases at baseline
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5× ULN (≤ 5.0× ULN for subjects with liver metastases)
  • Albumin ≥ 2.5 g/dL
  • Serum creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min

Key Exclusion Criteria:

• Prior exposure to ADCs with a Topo1 inhibitor payload.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Note: Patients may be considered for enrollment if they have previously treated brain metastases that are clinically stable or radiologically stable for at least 14 days prior to the first dose.

• Received radiotherapy within 21 days prior to the first dose of study drug. Note: For palliative radiotherapy for symptomatic improvement of non-central nervous system (CNS) lesions (total duration of radiotherapy ≤ 14 days), a radiation washout period of 7 days is required prior to the first dose.
• Any medical conditions that may confound the study results, interfere with the patient's compliance, or impair the interests of the subject, as assessed by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LCB02A monotherapy	Drug: LCB02A; CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of LCB02A (Phase 1 and 2)	Incidence and severity of AEs	Up to 48 months
Recommended Phase 2 dose of LCB02A (Phase 1)	Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics	Up to 24 months
Objective response rate (Phase 2)	Assessed by RECIST 1.1	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of LCB02A (Phase 1 and 2)	Pharmacokinetic parameters will be determined from observed concentrations of LCB02A	Up to 48 months
Duration of Response (Phase 1 and 2)	Assessed by RECIST v1.1	Up to 48 months
Disease control rate (Phase 1 and Phase 2)	Assessed by RECIST v1.1	Up to 48 months
Progression Free Survival (Phase 1 and Phase 2)	Assessed by RECIST v1.1	Up to 48 months
Overall Survival (Phase 1 and Phase 2)		Up to 48 months

Collaborators and Investigators

• Sponsor: LigaChem Biosciences, Inc.
• Collaborators: AntibodyChem Biosciences, Inc.
• Investigators: Study Director: Rodrigo Ruiz Soto, M.D., LigaChem Biosciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: CLDN18.2; Claudin 18.2
• Other Study ID Numbers: LCB02A-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No