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

NCT05877430 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CJB-101-01
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

NSCLC; HNSCC; Melanoma; Metastatic Cancer; Advanced Solid Tumor; Advanced Cancer

Keywords

Live Biotherapeutic Product; Keytruda; CJRB-101; metastatic; Immune checkpoint inhibitor; Pembrolizumab; CJB-101-01; anti-PD1; anti-PDL1

Outcome Measures

Primary Outcomes (2)

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

  Assessed per CTCAE v5.0

  Maximum 2 years

• [Phase 2] Efficacy

  ORR

  Maximum 2 years

Secondary Outcomes (8)

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

  Maximum 2 years

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

  Maximum 2 years

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

  Maximum 2 years

• Objective Response Rate (ORR)

  Maximum 2 years

• Disease Control Rate (DCR)

  Maximum 2 years

Study Arms (1)

CJRB-101 with pembrolizumab

EXPERIMENTAL

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.

Drug: CJRB-101; Drug: Pembrolizumab injection

Interventions

CJRB-101 DRUG

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.

CJRB-101 with pembrolizumab

Pembrolizumab injection DRUG

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

CJRB-101 with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CJ Bioscience, Inc.: lead

Study Sites (4)

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Melanoma; Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hyun Kim

CONTACT

+82-2-6078-3456; clinical.development@cj.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: May 26, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-08

Locations

KR (2); US (2)