Advanced Solid TumorsPhase 1/2NCT07460375
A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
A Phase 1/2 study testing LCB02A in people with Advanced Solid Tumors, run by LigaChem Biosciences, Inc. at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- LCB02A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 14 Oct 2026to Aug 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States4 sites, 4 recruiting
- Not yet recruiting
Mass General Hospital
Boston, Massachusetts, 02214
Haeseong Park, MD
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29406
A. Craig Lockhart, MD
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Mariela Blum Murphy, MD
- Recruiting
START New York - Long Island
Lake Success, New York, 11042
Geraldine O'Sullivan Coyne, MD
South Korea3 sites, 3 recruiting
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Do-Youn Oh, MD
- Not yet recruiting
ASAN Medical Center
Seoul, 05505
Min-Hee Ryu, MD
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
Minsuk Kwon, MD
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital
Toronto, Ontario, M5S 3H2
Erica Tsang, MD
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- LCB02A
- Keywords
- Claudin 18.2, CLDN18.2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCB02ADrug
CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.
| Study group | Role | What they receive |
|---|---|---|
| LCB02A monotherapy | Experimental | Not described Receives: Drug: LCB02A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of LCB02A (Phase 1 and 2)
Incidence and severity of AEs
Measured: Up to 48 months
Recommended Phase 2 dose of LCB02A (Phase 1)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Measured: Up to 24 months
Objective response rate (Phase 2)
Assessed by RECIST 1.1
Measured: Up to 24 months
Secondary outcomes (5)
Plasma concentrations of LCB02A (Phase 1 and 2)
Pharmacokinetic parameters will be determined from observed concentrations of LCB02A
Measured: Up to 48 months
Duration of Response (Phase 1 and 2)
Assessed by RECIST v1.1
Measured: Up to 48 months
Disease control rate (Phase 1 and Phase 2)
Assessed by RECIST v1.1
Measured: Up to 48 months
Progression Free Survival (Phase 1 and Phase 2)
Assessed by RECIST v1.1
Measured: Up to 48 months
Overall Survival (Phase 1 and Phase 2)
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start14 Oct 2026
- Primary completionFeb 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LigaChem Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AntibodyChem Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Rodrigo Ruiz Soto, M.D., Study director, LigaChem Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460375
- Sponsor's protocol ID
- LCB02A-1001
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07460375
- Acronym / sponsor ID
- LCB02A-1001
- Conditions
- Advanced Solid Tumors
- Keywords
- Claudin 18.2, CLDN18.2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- LigaChem Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AntibodyChem Biosciences, Inc.
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCB02A monotherapy | Experimental | Drug: LCB02A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCB02ACLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload. | Drug | LCB02A monotherapy |
Primary outcome
Safety of LCB02A (Phase 1 and 2)
Time frame: Up to 48 months
Incidence and severity of AEs
Recommended Phase 2 dose of LCB02A (Phase 1)
Time frame: Up to 24 months
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective response rate (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1
5 secondary outcomes
Plasma concentrations of LCB02A (Phase 1 and 2)
Time frame: Up to 48 months
Duration of Response (Phase 1 and 2)
Time frame: Up to 48 months
Disease control rate (Phase 1 and Phase 2)
Time frame: Up to 48 months
Progression Free Survival (Phase 1 and Phase 2)
Time frame: Up to 48 months
Overall Survival (Phase 1 and Phase 2)
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo Ruiz Soto, M.D. study director
LigaChem Biosciences
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LCB02A in people with Advanced Solid Tumors, run by LigaChem Biosciences, Inc. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Browning (+1-615-975-7776, clinicaltrials@ligachembio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of LCB02A (Phase 1 and 2) (time frame: Up to 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.