NCT07768189 · Corbus Pharmaceuticals Inc.
A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma
(TEMPO-1)
What this study is about
The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life.
View original scientific description
The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are: * What proportion of participants respond to CRB-701 measured using scans (CT or MRI) * What medical problems do participants experience when taking CRB-701. Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease). Participants will: * Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving. * Have a CT or MRI every 6 weeks to measure the effect on their cancer * Complete questionnaires to assess their health status.
Interventions
DRUG
CRB-701
CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)
DRUG
capcitabine
1250 mg/m2 twice daily on days 1-14 of each 21-day cycle
DRUG
Cetuximab (EGFR inhibitor)
400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.
DRUG
Docetaxel
75 mg/m2 as an IV infusion on day 1 of each 21-day cycle or 30 mg/m2 weekly to escalate to 40 mg/m2, if tolerated.
Primary outcome measures
Objective Response Rate (%)
Time frame: Up to 24 months
Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
Overall Survival (months)
Time frame: Approximately 3 years from randomization
Median time to death from any cause
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
- Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent.
- Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.
- ECOG PS of 0-1
- Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation.
- Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment. Signed informed consent
Exclusion criteria
- Persistent CTCAE Grade \>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.
- Significant active or chronic corneal disorders
- Pre-existing Grade ≥2 peripheral neuropathy
- Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results.
- Pregnant or breastfeeding females
Where
- Huntsville, Alabama
- Tucson, Arizona
- Duarte, California
- Los Angeles, California
- Palo Alto, California
- San Diego, California
- San Francisco, California
- Colorado Springs, Colorado
- Newhaven, Connecticut
- Newark, Delaware
- Orlando, Florida
- Tampa, Florida
And 23 more locations — see the full list below.
Collaborators
CSPC Megalith Biopharmaceutical Co.,Ltd.
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 Oct 8, 2026 · Source of record for eligibility and locations