NCT05877430 · CJ Bioscience, Inc.
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
What this study is about
Study CJB-101-01 will be conducted at multiple centers in the USA and Republic of Korea as an where both patients and doctors know the treatment given safety and preliminary effectiveness study of CJRB-101 in combination with pembrolizumab in subjects with selected types of advanced or metastatic cancer.
View original scientific description
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.
Interventions
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.
DRUG
Pembrolizumab injection
200 mg given by intravenous (IV) infusion once every 3 weeks
Primary outcome measures
[Phase 1&2] Tolerability and Safety: Incidence of Adverse Events
Time frame: Maximum 2 years
Assessed per CTCAE v5.0
[Phase 2] Efficacy
Time frame: Maximum 2 years
ORR
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 receive
Where
- Irvine, California
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 20, 2024 · Source of record for eligibility and locations