← Back to Search

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

Study Summary

This trial tests a new drug and a combination of drugs for advanced solid tumors refractory to standard care.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Benefit Rate (Phase 2)

Duration of Response (Phase 2)

Objective Response Rate (Phase 2)

+5 more

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

LigaChem Biosciences, Inc.Lead Sponsor

12 Previous Clinical Trials

502 Total Patients Enrolled

AntibodyChem Biosciences, Inc.UNKNOWN

LegoChem Biosciences, IncLead Sponsor

12 Previous Clinical Trials

502 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers is this clinical trial occupying?

"Presently, this clinical trial is being conducted in 7 medical sites. These include Boston, Ann Arbor and Hackensack amongst other locales. It would be most beneficial to select the site closest to you for convenience if you elect to participate."

Answered by AI

Are there any opportunities for recruitment into this investigation?

"Confirmed. Clinicaltrials.gov confirms that this trial, which was first posted on September 1st 2023 and updated lastly on July 4th 2023, is not recruiting participants at the moment. However, there are still 2,653 other trials seeking volunteers during this period of time."

Answered by AI

What are the prime goals of this investigation?

"The primary objective of this lengthy trial, which spans up to 48 months, is to determine the Recommended Phase 2 Dose for LCB84 administered solo or in combination with an anti-PD-1 Ab (Phase 1). Secondary outcomes that will be measured include immunogenicity as indicated by Occurrence of ADA at specified intervals and Objective Response Rate & Duration of Response according to RECIST 1.1, iRECIST, and RANO-BM metrics."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors

2023. "A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05941507.