What side effects are associated with this type of intervention?

TROP2-directed antibody-drug conjugates (ADCs) commonly cause side effects such as diarrhea, nausea, fatigue, neutropenia, and alopecia. Immune checkpoint inhibitors, like anti-PD-1 antibodies, are associated with immune-related adverse events including fatigue, rash, pruritus, diarrhea, and more severe conditions like pneumonitis, colitis, hepatitis, and endocrinopathies.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that are similar to those being studied in the LCB84 trial. TROP2-directed antibody-drug conjugates, such as sacituzumab govitecan, have been approved for the treatment of metastatic triple-negative breast cancer. Additionally, anti-PD-1 antibodies like nivolumab and pembrolizumab have received FDA approval for various solid tumors, including non-small cell lung cancer, melanoma, and head and neck squamous cell carcinoma. These treatments work by targeting specific proteins on cancer cells or by enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising novel alternatives for solid tumor treatment in 2024 include: 1) Sacituzumab govitecan (TROP2-directed antibody-drug conjugate) for various solid tumors, 2) Trastuzumab deruxtecan (HER2-directed antibody-drug conjugate) for HER2-positive cancers, 3) Pembrolizumab (anti-PD-1) combined with chemotherapy for non-small cell lung cancer, and 4) Nivolumab plus ipilimumab (dual immune checkpoint inhibition) for advanced melanoma and renal cell carcinoma.

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Checkpoint Inhibitor

TROP2 ADC + Anti-PD-1 for Solid Cancer

Phase 1 & 2

Recruiting

Research Sponsored by LigaChem Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Summary

This trial tests a new cancer treatment that targets and kills cancer cells directly and boosts the immune system. It is for patients with advanced cancers that don't respond to usual treatments. The study aims to find the best dose and safety of this new treatment.

Who is the study for?

This trial is for adults with advanced solid tumors that haven't responded to standard treatments or have no such options. Participants must be in good physical condition (ECOG 0 or 1), have certain blood cell counts within a healthy range, and their organs must function well. They should not have unresolved side effects from previous cancer treatments except hair loss and skin changes.

What is being tested?

The study tests LCB84, a new drug targeting TROP2 on tumor cells, alone and combined with an anti-PD-1 antibody that helps the immune system fight cancer. Phase 1 finds the safest dose; Phase 2 expands testing to more patients with specific types of tumors.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, nausea, lowered blood cell counts increasing infection risk, liver enzyme changes suggesting liver stress, and possibly others as this is a first-in-human study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Benefit Rate (Phase 2)

Duration of Response (Phase 2)

Objective Response Rate (Phase 2)

+5 more

Secondary study objectives

Duration of Response (Phase 1)

Evaluation of the immunogenicity of LCB84 (Phase 1 and 2)

Objective Response Rate (Phase 1)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: LCB84 monotherapyExperimental Treatment1 Intervention

IV infusion Q3W

Group II: LCB84 + anti-PD-1Experimental Treatment2 Interventions

IV infusion Q3W

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

TROP2-directed antibody-drug conjugates (ADCs) like LCB84 work by targeting the TROP2 protein, which is often overexpressed on the surface of solid tumor cells. The ADC binds to TROP2, delivering a cytotoxic drug directly to the cancer cells, thereby minimizing damage to healthy cells. Anti-PD-1 antibodies, such as those used in immune checkpoint inhibition, block the PD-1 pathway, which tumors exploit to evade the immune system. By inhibiting this pathway, these antibodies enhance the body's immune response against cancer cells. These mechanisms are crucial for solid tumor patients as they offer targeted and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.

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Who is running the clinical trial?

LigaChem Biosciences, Inc.Lead Sponsor

12 Previous Clinical Trials

442 Total Patients Enrolled

AntibodyChem Biosciences, Inc.UNKNOWN

LegoChem Biosciences, IncLead Sponsor

12 Previous Clinical Trials

442 Total Patients Enrolled

Media Library

Anti-PD-1 monoclonal antibody (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05941507 — Phase 1 & 2

Solid Tumors Research Study Groups: LCB84 monotherapy, LCB84 + anti-PD-1

Solid Tumors Clinical Trial 2023: Anti-PD-1 monoclonal antibody Highlights & Side Effects. Trial Name: NCT05941507 — Phase 1 & 2

Anti-PD-1 monoclonal antibody (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05941507 — Phase 1 & 2

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