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CJRB-101 + Pembrolizumab for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by CJ Bioscience, Inc.

Eligibility Criteria Checklist

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

Must have

≥18 years of age at the time of signing the informed consent form

Pathologically documented histological or cytological evidence of NSCLC, HNSCC, or melanoma

Must not have

NSCLC subjects with EGFR or ALK genomic tumor aberrations

With uncontrolled or untreated brain metastasis or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial will take place at different locations in the USA and Republic of Korea. It will test the safety and effectiveness of CJRB-101 combined with pembrolizumab in patients with certain types

Who is the study for?

This trial is for adults over 18 with certain advanced cancers (NSCLC, HNSCC, or melanoma) that haven't been treated yet or didn't respond to previous treatments. Participants need a measurable cancer lesion and specific PD-L1 expression levels depending on their cancer type. They shouldn't have had systemic treatment for metastatic disease but can join if it's been 6+ months since adjuvant therapy.

What is being tested?

The study tests CJRB-101 combined with pembrolizumab injections in patients with selected advanced cancers. It aims to improve response rates where immune checkpoint inhibitors alone aren’t enough by evaluating safety, tolerability, dose limits, and effects on microbiome biomarkers.

What are the potential side effects?

Potential side effects include typical reactions associated with immunotherapy such as fatigue, skin reactions, inflammation of organs like the lungs or intestines (pneumonitis or colitis), hormonal imbalances (endocrinopathies), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer (lung, head/neck, or skin) has been confirmed by lab tests.

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I have a tumor that can be measured and hasn't been treated or removed yet.

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My severe side effects have improved to mild or moderate.

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I have advanced NSCLC, HNSCC, or melanoma and haven't had ICI treatment or it didn't work.

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I am fully active or can carry out light work.

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I am willing to provide tissue samples for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung cancer has specific genetic changes in EGFR or ALK.

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I have untreated brain metastasis or leptomeningeal disease.

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I have received a fecal transplant.

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I have chronic hepatitis B with high viral load.

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I have had major surgery on my digestive system.

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I am not pregnant or breastfeeding.

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I am a male and willing to use birth control to prevent pregnancy.

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I cannot swallow capsules.

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I am experiencing symptoms of colitis.

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I have been treated for an autoimmune disease in the last 2 years.

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I cannot have IV contrast, even with pre-medication.

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I have not received a live vaccine in the last 4 weeks.

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I have or had lung inflammation treated with steroids.

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I haven't taken any antibiotics, antifungals, or antivirals in the last 14 days.

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I stopped taking immune therapy due to severe side effects.

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I have active hepatitis C.

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I have had active inflammatory bowel disease causing diarrhea in the last year.

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I have a heart condition that affects my daily life.

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I do not have any conditions that would make Keytruda unsafe for me.

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I have a history of immunodeficiency or an organ transplant and need immunosuppressive therapy.

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I have a known history of HIV.

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I haven't had major surgery, except for a biopsy, in the last 4 weeks or I've fully recovered from it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

[Phase 1&2] Tolerability and Safety: Incidence of Adverse Events

[Phase 2] Efficacy

Secondary study objectives

Disease Control Rate (DCR)

Duration Of Response (DOR)

Objective Response Rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CJRB-101 with pembrolizumabExperimental Treatment2 Interventions

Phase 1 includes patients with selected types of advanced or metastatic cancers. Patients will be given with either low or high dose levels of CJRB-101 in combination with pembrolizumab. Phase 2 includes patients with selected types of advanced or metastatic cancers. Patients will be given with the CJRB-101 dose selected from Phase 1 in combination with pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab injection

2023

Completed Phase 1

~60

0 / 29Eligibility criteria met