A Phase 3 interventional study of CRB-701 and capcitabine in Oropharyngeal Carcinoma (OPC), sponsored by Corbus Pharmaceuticals Inc.. Recruiting at 111 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Corbus Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
Belgium, Canada, France, Germany, Hungary, Italy, Portugal, Romania, South Korea, Spain, Taiwan
Among 233 studies in Oropharyngeal Neoplasms with a site in United States — 61 open to participants now, 96 under way, 10 of them phase 3. Oropharyngeal Neoplasms · United States.
Among the 233 studies in Oropharyngeal Neoplasms with a site in United States, this one is the 22nd largest by planned enrollment of the 188 interventional ones, is one of 8 that started in 2026, is one of 13 in phase 3, reaches primary completion later than 49 of the 95 other live ones, and was the 229th registered.
369 studies on the registry are indexed under Oropharyngeal Neoplasms; 103 are open to participants now.
This study's planned enrollment of 260 is above the median of 52 across 265 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →61 of the 233 studies in Oropharyngeal Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 89 Oropharyngeal Neoplasms studies recruiting now, 76 (85%) set no upper age limit and 5 (6%) stop at 75 or younger; 0 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →233 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 8 started in 2026.
Median enrollment 42 across the 188 interventional studies, 185 across the 35 observational. Of the 120 that completed or were terminated, 53 (44%) have results posted.
21 of 233 have an industry lead sponsor. The 10 most frequent:
Corbus Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Corbus Pharmaceuticals Inc. has 1 study filed under Oropharyngeal Neoplasms — fewer than ten, so there is no comparison to draw.
33 of the studies in Oropharyngeal Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT05050162Phase 3NRG OncologyComparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer | 2027-02-09 |
| NCT02215265Phase 3Lisette NixonPost-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS) | 2027-10 |
| NCT06747390Ryan CareyIntratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery | 2026-11-01 |
| NCT04609280University of Maryland, BaltimoreSelective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110) | 2026-12 |
Among the 233 studies in Oropharyngeal Neoplasms with a site in United States, from their registry updates:
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:
Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease).
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3.6mg/Kg CRB-701 administered intravenously Q3W.
Drug: CRB-701
Investigator's choice of capecitabine, cetuximab or docetaxel
Drug: capcitabine · Drug: Cetuximab (EGFR inhibitor) · Drug: Docetaxel
CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)
1250 mg/m2 twice daily on days 1-14 of each 21-day cycle
400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.
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.
Objective Response Rate (%)
Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
Time frame: Up to 24 months
Overall Survival (months)
Median time to death from any cause
Time frame: Approximately 3 years from randomization
Progression Free Survival (Months)
Median time to radiographic progression per RECIST 1.1 as assessed by BICR
Time frame: up to 24 months from randomization
Duration of Response (Months)
Duration of response to intervention as measured by RECIST 1.1 and assessed by BICR
Time frame: Up to approximately 2 years
Change in baseline in EORTC QLQ-C30 functional and symptom scales
Change from baseline in functional and symptom scales on the EORTC QLQ-C30 questionnaire. All individual functions and symptoms are measured on a scale ranging 1-4. In the functional scales a higher score represents better functioning and health. With the symptom scales a higher score represents a more severe symptom and poor health. A total score of 0-100 is derrived from the raw scores with a higher score indicating better health
Time frame: up to approximately 2 years
Objective Response Rate (%)
Proportion of participants that respond to treatment by RECIST 1.1 assessed by Investigator
Time frame: Up to approximate 2 years
Time to Response (days)
Median time to response as measured by RECIST 1.1 and asssessed by BICR
Time frame: up to approx 2 years
Time to Response (days)
Time to response as measured by RECIST v 1.1 as assessed by Investigator
Time frame: up to approximately 2 years
Number of participants experiencing a treatment emergent adverse events
Total number of participant experiencing adverse events per treatment group irrespective of relationship to study treatment.
Time frame: Up to approximately 2 years
Number of participants experiencing a serious treatment emergent adverse event
Number of participants who experienced a serious treatment emergent adverse events per treatment group irrespective of relationship to treatment.
Time frame: Up to approximately 2 years
Number of participants that had a treatment modification due to an adverse event
Number of participants that had a treatment modification due to an adverse event per treatment arm. Dose modifications include dose reductions and treatment delays.
Time frame: Up to approx. 2 years
Number of participants who discontinued study treatment due to a treatment emergent adverse event
Number of participants who discontinued study treatment due to a treatment adverse event per treatment group, irrespective of relationship to the study treatment.
Time frame: Up to approximately 2 years
Showing the first 100 of 111 sites across 14 countries. Choose a country and city above to see the rest.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2027, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
Belgium, Canada, France, Germany, Hungary, Italy, Portugal, Romania, South Korea, Spain, Taiwan
Belgium, Canada, France, Germany, Hungary, Italy, Portugal, Romania, South Korea, Spain, Taiwan
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sutantatug Envedotin
Corbus Pharmaceuticals Inc.