NCT06603844 · Corbus Pharmaceuticals Inc.
First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.
What this study is about
The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others.
View original scientific description
The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein.
Interventions
DRUG
CRB-601 monoclonal antibody
CRB-601
DRUG
Anti-PD-1 monoclonal antibody
Anti-PD(L)-1 used as per label
Primary outcome measures
Occurance of Dose-limiting toxicities
Time frame: 28 days
Characterize the safety of CRB-601 in combination anti-PD(L)1 therapy
Time frame: 6 months
Incidence of treatment emergent adverse events and clinically significant changes in laboratory parameters, ECG, vital signs and physical exam findings over treatment duration
To evaluate the efficacy of CRB-601 in terms of DCR when administered in combination with anti-PD(L)-1
Time frame: 6 months
Disease Control Rate (Complete Responses plus Partial Responses plus Stable Disease for at least 4 months as determined by the Investigator using RECIST 1.1.
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
- Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available.
- Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.
- Life expectancy of more than 12 weeks.
- Adequate hematologic and end-organ function.
Exclusion criteria
- History of solid tumor malignancies other than the disease under study within 3 years of study enrollment
- History of and/or current cardiovascular events or conditions
- Chronic severe liver disease or liver cirrhosis
- Systemic autoimmune disease
- Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes.
- Interstitial lung disease within 6 months of study enrollment.
- Active or persistent infection
- Other conditions that in the opinion of the Investigat
Where
- Birmingham, Alabama
- Tucson, Arizona
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Denver, Colorado
- Orlando, Florida
- Chicago, Illinois
- Maple Grove, Minnesota
- Lincoln, Nebraska
- Durham, North Carolina
- Cleveland, Ohio
And 6 more locations — see the full list below.
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 Jun 3, 2025 · Source of record for eligibility and locations