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

Part of paid clinical trials in Irvine, California.

Sponsor
CJ Bioscience, Inc.
Study ID
NCT05877430
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Pembrolizumab injection — DRUG
    200 mg given by intravenous (IV) infusion once every 3 weeks

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Aug 2024
Primary completion
Jul 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CJRB-101 with pembrolizumab
    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.

Primary Outcome Measure

[Phase 1&2] Tolerability and Safety: Incidence of Adverse Events [ Time Frame: Maximum 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Misako Nagasaka, MD, PhD
University of PittsburghPittsburghPennsylvania15260
Diwakar Davar, MD

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