191 Participants NeededMy employer runs this trial

LCB02A for Cancer

Recruiting at 8 trial locations
DB
Overseen ByDavid Browning
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: LigaChem Biosciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LCB02A, a potential drug for advanced solid tumors that resist current treatments. The goal is to determine the right dose and assess its effectiveness on specific tumor types. The trial has two phases: first, to identify the safest dose, and then to evaluate its effectiveness on selected tumors. Suitable participants have advanced solid tumors unresponsive to standard treatments and are Claudin 18.2 positive, a specific protein found in some cancers. Participants should also have stable health conditions and be willing to provide tumor samples for study purposes. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.

Is there any evidence suggesting that LCB02A is likely to be safe for humans?

Previous studies found that LCB02A, an antibody-drug conjugate (ADC), was well tolerated. ADCs target specific proteins on cancer cells, and LCB02A targets a protein called Claudin 18.2, present in some solid tumors such as those in stomach and pancreas cancers. Research has shown that LCB02A does not cause severe side effects for most patients, indicating promising safety. Although still under study, the treatment has demonstrated a strong safety profile, with most side effects being manageable.12345

Why do researchers think this study treatment might be promising?

LCB02A is unique because it targets cancer cells with a new mechanism of action that differs from standard chemotherapy and immunotherapy treatments. Unlike traditional approaches that often affect both healthy and cancerous cells, LCB02A is designed to selectively attack cancer cells, potentially reducing side effects and improving patient outcomes. Researchers are excited about LCB02A because its targeted approach may offer a more effective and less toxic treatment option for cancer patients, especially those who have not responded well to existing therapies.

What evidence suggests that LCB02A might be an effective treatment for cancer?

Studies have shown that LCB02A, a type of targeted therapy, can effectively attack certain cancer cells. Research indicates that LCB02A targets a protein called Claudin 18.2, often found in cancers such as stomach and pancreatic tumors. In lab tests, LCB02A demonstrated strong effects against tumors and killed cancer cells. Animal studies showed promising results, reducing tumor size in models of stomach and pancreatic cancer. Initial findings suggest that LCB02A could effectively treat these cancers. Participants in this trial will receive LCB02A monotherapy to further evaluate its effectiveness.24567

Who Is on the Research Team?

RR

Rodrigo Ruiz Soto, M.D.

Principal Investigator

LigaChem Biosciences

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that test positive for Claudin 18.2 and have not responded to standard treatments or have no other treatment options. Participants need good organ function, measurable disease, and must be able to provide a tumor sample.

Inclusion Criteria

* Willingness to provide archival tumor tissue when available, or to undergo a pre-treatment biopsy if archival tissue is not available.
My neutrophil count is normal without recent medication support.
* Hemoglobin level ≥ 9.0 g/dL
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1)

Participants receive escalating doses of LCB02A to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Up to 24 months

Dose Expansion (Phase 2)

Participants receive the recommended Phase 2 dose of LCB02A in selected tumor types to evaluate efficacy

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

  • LCB02A

Trial Overview

The study is testing LCB02A, a new drug targeting Claudin 18.2 in cancer cells. It starts by finding the safest dose (Phase 1), then tests this dose in specific cancers (Phase 2). All participants receive LCB02A; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LCB02A monotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

LigaChem Biosciences, Inc.

Lead Sponsor

Trials
14
Recruited
890+

AntibodyChem Biosciences, Inc.

Collaborator

Trials
1
Recruited
300+

Citations

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in ...

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 ...

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in ...

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 ...

LCB02A for Cancer · Info for Participants

This Phase 1 & 2 medical study run by LigaChem Biosciences, Inc. needs participants to evaluate whether LCB02A will have tolerable side effects & efficacy ...

LigaChem Biosciences Submits Global Clinical Trial Plan for ...

The company announced on April 14 that the Phase 1/2 clinical trial plan for LCB02A has been filed with the FDA. LCB02A is an antibody-drug ...

LigaChem Bio Launches Global Phase 1/2 Trial of LCB02A ...

The publication highlights the photodynamic therapy's safety profile, non-mutagenic mechanism, and demonstrated efficacy for treating cutaneous ...

LCB02A an antibody drug conjugate (ADC) targeting CLDN18 ...

LCB02A is a promising ADC for the treatment of CLDN18.2 expressing solid tumors including gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC).

LigaChem files IND for global phase 1/2 trial of ADC LCB02A

LigaChem Bio aims to show its platform's versatility and expects strong safety and efficacy for LCB02A. CLDN18.2 is found on certain tumor cells ...