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

NCT07460375 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LCB02A-1001
• Study Type: interventional
• Target: 191
• Locations: 3 countries
• Sites: 8

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Claudin 18.2; CLDN18.2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Plasma concentrations of LCB02A (Phase 1 and 2)

  Up to 48 months

• Duration of Response (Phase 1 and 2)

  Up to 48 months

• Disease control rate (Phase 1 and Phase 2)

  Up to 48 months

• Progression Free Survival (Phase 1 and Phase 2)

  Up to 48 months

• Overall Survival (Phase 1 and Phase 2)

  Up to 48 months

Study Arms (1)

LCB02A monotherapy

EXPERIMENTAL

Drug: LCB02A

Interventions

LCB02A DRUG

CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.

LCB02A monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Creatinine clearance ≥ 60 mL/min

You may not qualify if:

• 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.

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead
• AntibodyChem Biosciences, Inc.: collaborator

Study Sites (8)

Mass General Hospital

Boston, Massachusetts, 02214, United States

NOT YET RECRUITING

START New York - Long Island

Lake Success, New York, 11042, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29406, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5S 3H2, Canada

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

NOT YET RECRUITING

ASAN Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

Study Officials

• Rodrigo Ruiz Soto, M.D.

  LigaChem Biosciences

  STUDY DIRECTOR

Central Study Contacts

David Browning

CONTACT

+1-615-975-7776; clinicaltrials@ligachembio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (1); KR (3)