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NSCLCPhase 1/2NCT05877430

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

A Phase 1/2 study testing CJRB-101 and Pembrolizumab injection in people with NSCLC and HNSCC, run by CJ Bioscience, Inc. at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study CJB-101-01 will be conducted at multiple centers in the USA and Republic of Korea as an open-label safety and preliminary efficacy study of CJRB-101 in combination with pembrolizumab in subjects with selected types of advanced or metastatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, HNSCC, Melanoma
What is being tested?
CJRB-101 and Pembrolizumab injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
4 sitesin 2 countries
Study dates
11 Sep 2023to Oct 2027
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

  • Willing and able to provide informed consent
  • ≥18 years of age at the time of signing the informed consent form
  • Pathologically documented histological or cytological evidence of NSCLC, HNSCC, or melanoma.
  • Has at least 1 measurable target lesion per RECIST v1.1 that has not been resected/biopsied/or irradiated before enrollment in the study
  • Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma in subjects who are ICI treatment-naive or relapsed/refractory, including PD-1/PD-L1 inhibitors
  • ICI treatment-naive subjects must meet the following criteria:
Show all 18Show fewer
  • NSCLC: Subjects with metastatic or with unresectable, recurrent NSCLC whose tumors must have no EGFR or ALK genomic aberrations and express PD-L1 [TPS≥50%]
  • HNSCC: Subjects with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [CPS ≥20]
  • Melanoma: Irrespective of PD-L1 result and BRAF V600 mutation
  • Subjects has not received prior systemic treatment for their metastatic tumor. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months before the development of metastatic disease.
  • ICI treatment-refractory subjects as defined by the following criteria:
  • Has received at least 2 cycles of anti-PD-(L)1 therapy either as monotherapy or in combination
  • Has demonstrated disease progression after ICI treatment by RECIST v1.1
  • Has received less than three lines of systemic therapy for metastatic tumor
  • ECOG performance status of 0 or 1
  • Be willing to provide archival tissue or fresh biopsy
  • Have adequate organ function
  • All Grade 3 or greater AEs resolved earlier to Grade 2 or less

Who cannot join

  • Cancer type and genomic tumor aberrations:
  • NSCLC subjects with EGFR or ALK genomic tumor aberrations
  • HNSCC subjects with nasopharyngeal cancer
  • For ICI refractory/relapsed subjects: Immune related AEs ≥Grade 3 that led to discontinuation of prior immune-modulatory agents including PD-1/PD-L1 inhibitors
  • With uncontrolled or untreated brain metastasis or leptomeningeal disease
  • Active autoimmune disease that has required systemic treatment in the past 2 years
Show all 30Show fewer
  • Received a fecal transplant
  • Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days of study consent
  • Contraindication to IV contrast that cannot be managed with pre-medication
  • Female subjects who are pregnant or breastfeeding
  • Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy
  • Has a known inability for oral intake of capsules
  • Has received a live vaccine within 4 weeks of start of the study treatment
  • Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
  • Has received whole blood transfusion, blood component transfusion, or colony stimulating factors within 1 week prior to the 1st dose of study treatment
  • In the judgment of the investigator, subjects unlikely to comply with study procedures, restrictions and requirements
  • Has active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids
  • Have allergy to clindamycin, erythromycin, and ampicillin
  • Has signs and symptoms of colitis at screening
  • Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before study treatment (Note: Antiviral therapy is permitted for subjects with chronic HBV or HCV infection)
  • Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA>500 IU/mL (or >2500 copies/mL) at screening (Note: Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Subjects with detectable HbsAg or detectable HBV DNA should be managed per treatment guidelines. Subjects receiving antivirals at screening should have been treated for > 2 weeks before study treatment.)
  • With active hepatitis C (Note: Subjects with a negative HCV antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible. The HCV RNA test will be performed only for subjects testing positive for HCV antibody. Subjects receiving antivirals at screening should have been treated for > 2 weeks before study treatment.)
  • Known history of HIV infection
  • History of active inflammatory bowel disease with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of study informed consent and or if the subject has not fully recovered from the surgery within 4 weeks of informed consent
  • History of major gastrointestinal surgery
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
  • Currently active, clinically significant cardiovascular disease
  • Known active intravenous drug or alcohol abuse or use of other drugs of abuse
  • Has any contraindication as mentioned in the recent Keytruda, Highlights of Prescribing Information (pembrolizumab)

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Hyun Kim contact

+82-2-6078-3456

clinical.development@cj.net

4 sites in 2 countries

United States2 sites, 2 recruiting

  • University of California, Irvine

    Irvine, California, 92697

    Misako Nagasaka, MD, PhD

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

    Diwakar Davar, MD

    Recruiting

Other trials in United States

South Korea2 sites, 2 recruiting

  • Samsung Medical Center

    Seoul

    Hyun Kim, 82260783456, clinical.development@cj.net

    Recruiting

  • Severance Hospital

    Seoul

    Hyun Kim, 82-2-60783456, clinical.development@cj.net

    Recruiting

Other trials in South Korea

About this study

Official title: Phase 1/2 Open Label, Safety and Preliminary Efficacy Study of a Live Biotherapeutic Product (CJRB-101) in Combination With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

Study CJB-101-01 will be conducted at multiple centers in the USA and Republic of Korea as an open-label safety and preliminary efficacy study of CJRB-101 in combination with pembrolizumab in subjects with selected types of advanced or metastatic cancer. The proposed study intends to address the unmet medical needs of low response rate and refractoriness to immune checkpoint inhibitors typically observed in this subject population by performing assessments of response, dose limiting toxicities, pharmacodynamic, and the effect on microbiome biomarkers at different dose levels of CJRB-101 combined with pembrolizumab.

Being tested
CJRB-101, Pembrolizumab injection
Keywords
Live Biotherapeutic Product, Keytruda, CJRB-101, metastatic, Immune checkpoint inhibitor, Pembrolizumab, CJB-101-01, anti-PD1, anti-PDL1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CJRB-101Drug

    In Phase 1, one or two capsules of CJRB-101 will be given every day. In Phase 2, the CJRB-101 dose selected from Phase 1 will be given every day.

  • Pembrolizumab injectionDrug

    200 mg given by intravenous (IV) infusion once every 3 weeks

Study groups in NCT05877430
Study groupRoleWhat they receive
CJRB-101 with pembrolizumabExperimentalPhase 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.
Receives: Drug: CJRB-101; Drug: Pembrolizumab injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Assessed per CTCAE v5.0

    Measured: Maximum 2 years

  2. [Phase 2] Efficacy

    ORR

    Measured: Maximum 2 years

Secondary outcomes (8)

  1. [Phase 1&2] Effects of therapy on the microbiome biomarkers - Stool

    Fecal samples will be used to analyze gut microbiome using amplicon sequencing and/or whole-genome shotgun metagenomic sequencing.

    Measured: Maximum 2 years

  2. [Phase 1&2] Effects of therapy on the pharmacodynamic biomarkers - Blood

    Blood samples will be analyzed for the immune profiling and biomarkers of therapy effect.

    Measured: Maximum 2 years

  3. [Phase 1&2] Effects of therapy on the pharmacodynamic biomarkers - Tumor

    Tumor tissue samples will be analyzed for immune profiling and evaluated for prediction of therapy effectiveness.

    Measured: Maximum 2 years

  4. Objective Response Rate (ORR)

    Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1.

    Measured: Maximum 2 years

  5. Disease Control Rate (DCR)

    Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1.

    Measured: Maximum 2 years

  6. Duration Of Response (DOR)

    Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1.

    Measured: Maximum 2 years

  7. Progression Free Survival (PFS)

    Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1.

    Measured: Maximum 2 years

  8. Overall survival (OS)

    Measured: Maximum 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start11 Sep 2023
  3. Primary completionJul 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877430
Sponsor's protocol ID
CJB-101-01
Status last verified
Aug 2024
First submitted
12 Mar 2023
Last updated
20 Dec 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lee JB, Baek S, Kim DK, Kwon BE, Ahn JS, Nagasaka M, Davar D, Park H, Kim H, Im J, Yang J, Yang E, Shin GH, Choi S, Kwon JE, Kim JM, Kang SY, Kim Y, Park SY, Kim JH, Oh HS, Chalita M, Min A, Cho BC. Phase I trial of CJRB-101 plus pembrolizumab in patients with metastatic non-small cell lung cancer, head and neck squamous cell carcinoma and melanoma. J Immunother Cancer. 2026 May 15;14(5):e014702. doi: 10.1136/jitc-2025-014702.

    PubMed 42140743

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CJRB-101 and Pembrolizumab injection in people with NSCLC and HNSCC, run by CJ Bioscience, Inc. at 4 sites in 2 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 18 inclusion and 30 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, South Korea. 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 Hyun Kim (+82-2-6078-3456, clinical.development@cj.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Phase 1&2] Tolerability and Safety: Incidence of Adverse Events (time frame: Maximum 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05877430, which also lists 1 linked publication.

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 20 Dec 2024.

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