Is NCT05877430 recruiting in Irvine, CA?

Yes, NCT05877430 is currently recruiting participants at its Irvine, CA location. This metastatic cancer clinical trial is actively enrolling qualified participants.

How do I join the metastatic cancer clinical trial in Irvine?

To join this clinical trial in Irvine, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Irvine clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Cancer Clinical Trial in Irvine, CA

About This Metastatic Cancer Study in Irvine

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,

Sponsor: CJ Bioscience, Inc.

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Irvine?

Yes, this clinical trial (NCT05877430) has an active research site in Irvine, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Cancer Treatment Options in Irvine, CA

If you're searching for metastatic cancer treatment options in Irvine, CA, this clinical trial (NCT05877430) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Irvine research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced metastatic cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic cancer clinical trials near you to find additional studies recruiting in your area.

Metastatic Cancer Clinical Trial in Irvine, CA

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