Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05877430
Other study ID # CJB-101-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 11, 2023
Est. completion date October 2027

Study information

Verified date December 2023
Source CJ Bioscience, Inc.
Contact Hyun Kim
Phone +82-2-6078-3456
Email clinical.development@cj.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date October 2027
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Willing and able to provide informed consent 2. =18 years of age at the time of signing the informed consent form 3. Pathologically documented histological or cytological evidence of NSCLC, HNSCC, or melanoma. 4. Has at least 1 measurable target lesion per RECIST v1.1 that has not been resected/biopsied/or irradiated before enrollment in the study 5. 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 6. ICI treatment-naive subjects must meet the following criteria: 1. 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%] 2. HNSCC: Subjects with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [CPS =20] 3. Melanoma: Irrespective of PD-L1 result and BRAF V600 mutation 4. 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. 7. ICI treatment-refractory subjects as defined by the following criteria: 1. Has received at least 2 cycles of anti-PD-(L)1 therapy either as monotherapy or in combination 2. Has demonstrated disease progression after ICI treatment by RECIST v1.1 3. Has received less than three lines of systemic therapy for metastatic tumor 8. ECOG performance status of 0 or 1 9. Be willing to provide archival tissue or fresh biopsy 10. Have adequate organ function 11. All Grade 3 or greater AEs resolved earlier to Grade 2 or less Exclusion Criteria: 1. Cancer type and genomic tumor aberrations: 1. NSCLC subjects with EGFR or ALK genomic tumor aberrations 2. HNSCC subjects with nasopharyngeal cancer 2. 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 3. With uncontrolled or untreated brain metastasis or leptomeningeal disease 4. Active autoimmune disease that has required systemic treatment in the past 2 years 5. Received a fecal transplant 6. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days of study consent 7. Contraindication to IV contrast that cannot be managed with pre-medication 8. Female subjects who are pregnant or breastfeeding 9. Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy 10. Has a known inability for oral intake of capsules 11. Has received a live vaccine within 4 weeks of start of the study treatment 12. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy 13. Has received whole blood transfusion, blood component transfusion, or colony stimulating factors within 1 week prior to the 1st dose of study treatment 14. In the judgment of the investigator, subjects unlikely to comply with study procedures, restrictions and requirements 15. Has active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids 16. Have allergy to clindamycin, erythromycin, and ampicillin 17. Has signs and symptoms of colitis at screening 18. 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) 19. 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.) 20. 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.) 21. Known history of HIV infection 22. History of active inflammatory bowel disease with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months 23. 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 24. History of major gastrointestinal surgery 25. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial 26. Currently active, clinically significant cardiovascular disease 27. Known active intravenous drug or alcohol abuse or use of other drugs of abuse 28. Has any contraindication as mentioned in the recent Keytruda, Highlights of Prescribing Information (pembrolizumab)

Study Design


Intervention

Drug:
CJRB-101
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 injection
200 mg given by intravenous (IV) infusion once every 3 weeks

Locations

Country Name City State
Korea, Republic of CJ bioscience investigative site Seoul

Sponsors (1)

Lead Sponsor Collaborator
CJ Bioscience, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary [Phase 1&2] Tolerability and Safety: Incidence of Adverse Events Assessed per CTCAE v5.0 Maximum 2 years
Primary [Phase 2] Efficacy ORR Maximum 2 years
Secondary [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. Maximum 2 years
Secondary [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. Maximum 2 years
Secondary [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. Maximum 2 years
Secondary Objective Response Rate (ORR) Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1. Maximum 2 years
Secondary Disease Control Rate (DCR) Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1. Maximum 2 years
Secondary Duration Of Response (DOR) Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1. Maximum 2 years
Secondary Progression Free Survival (PFS) Antitumor effect is assessed through tumor image and tumor lesion per RECIST v1.1. Maximum 2 years
Secondary Overall survival (OS) Maximum 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT03979872 - Risk Information and Skin-cancer Education for Undergraduate Prevention N/A
Recruiting NCT04986748 - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Recruiting NCT05077137 - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy Phase 1
Active, not recruiting NCT02721459 - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma Phase 1
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT05839912 - Excision of Lymph Node Trial (EXCILYNT) (Mel69) N/A
Recruiting NCT04971499 - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma Phase 1/Phase 2
Recruiting NCT05263453 - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation Phase 2
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06413680 - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies Phase 1/Phase 2
Completed NCT03348891 - TNF in Melanoma Patients Treated With Immunotherapy N/A
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03171064 - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment Phase 2
Not yet recruiting NCT05539118 - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma Phase 1/Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn NCT02854488 - Yervoy Pregnancy Surveillance Study