CRB-701 for Throat Cancer

(TEMPO-1 Trial)

Not yet recruiting at 28 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Corbus Pharmaceuticals Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new drug, CRB-701, can treat throat cancer that has returned or spread after previous treatments. CRB-701 is a specialized chemotherapy designed to target cancer cells more precisely. Researchers aim to evaluate its effectiveness compared to standard medicines and assess its safety and impact on quality of life. Individuals with throat cancer affecting the tonsils or throat, who have already undergone chemotherapy and immunotherapy, might be suitable candidates. Participants will visit a clinic every three weeks for treatment and undergo regular scans to monitor progress. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found CRB-701 to be generally safe and well-tolerated. Fewer than 3% of patients stopped treatment due to side effects. Common side effects included eye inflammation, tiredness, hair loss, changes in taste, and low red blood cell count. This safety profile remained consistent across various cancer types, including head and neck cancers. Thus far, CRB-701 appears to be a promising option with manageable side effects.12345

Why do researchers think this study treatment might be promising for throat cancer?

CRB-701 is unique because it introduces a new approach for treating throat cancer by utilizing an innovative active ingredient that specifically targets cancer cells. Unlike traditional treatments like capecitabine, cetuximab, or docetaxel, which have been the mainstays of care, CRB-701 is administered intravenously every three weeks, potentially offering a more convenient dosing schedule. Researchers are particularly excited about CRB-701 because it has the potential to improve outcomes by directly attacking the cancer cells with precision, which could lead to more effective and potentially fewer side effects compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for throat cancer?

Research has shown that CRB-701, one of the treatments studied in this trial, yields promising results for head and neck cancers, including throat cancer. Previous studies found that nearly half of the patients experienced tumor shrinkage, and patients lived longer without disease progression. CRB-701 is a type of targeted chemotherapy known as an antibody-drug conjugate, which delivers the drug directly to cancer cells, potentially reducing harm to healthy cells. These findings suggest that CRB-701 could effectively treat throat cancer, especially for those unresponsive to treatments like platinum-based chemotherapy or immunotherapy. Participants in this trial may receive CRB-701 or an investigator's choice of capecitabine, cetuximab, or docetaxel as monotherapy.678910

Who Is on the Research Team?

CP

Cesar Peres, MD

Principal Investigator

Florida Cancer Specialists and Research Institute and Sarah Cannon Research Institute

PN

Pablo Nenclares, MD

Principal Investigator

Barts & The London NHS Trust

AR

Ari Rosenberg, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults with oropharyngeal (throat) squamous cell cancer who have already been treated with platinum-based chemotherapy or immunotherapy, but whose cancer has come back or not responded. Participants should be healthy enough for more treatment.

Inclusion Criteria

Life expectancy greater than 12 weeks at time of enrollment as per Investigator's assessment
I have at least one tumor that can be measured and has not been treated with radiation.
Signed informed consent
See 3 more

Exclusion Criteria

I have ongoing moderate or severe side effects from past cancer treatments, except hair loss.
I have serious ongoing or current corneal (eye surface) problems.
I have moderate or severe nerve damage symptoms.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive infusions of CRB-701 or standard of care medicines every three weeks until the cancer cannot be measured or is not controlled by the treatment

Up to 2 years
Clinic visits every 3 weeks

Monitoring

Participants undergo CT or MRI every 6 weeks to measure the effect on their cancer and complete health status questionnaires

Up to 2 years
CT/MRI every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Capecitabine
  • Cetuximab
  • CRB-701
  • Docetaxel

Trial Overview

The study compares a new targeted drug called CRB-701 to standard treatments like capecitabine, docetaxel, or cetuximab. Patients are randomly assigned to receive either CRB-701 or one of the usual drugs every three weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CRB-701Experimental Treatment1 Intervention
Group II: Investigator's Choice monotherapyActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corbus Pharmaceuticals Inc.

Lead Sponsor

Trials
9
Recruited
1,800+

CSPC Megalith Biopharmaceutical Co.,Ltd.

Industry Sponsor

Trials
2
Recruited
410+

Citations

Corbus Pharmaceuticals Announces FDA Clearance to Initiate ...

CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) ...

CSPC Pharmaceutical's Nectin-4 Targeting ADC CRB-701 Receives ...

The product previously received Fast Track Designations from the FDA for both head and neck squamous cell carcinoma (HNSCC) and cervical cancer, underscoring ...

Corbus Pharma Reports CRB-701 Clinical Data

Data Comparison: The ESMO25 data from 2025 indicated confirmed objective response rates of 47.6% and 37.5% for CRB-701 in head and neck squamous cell carcinoma ...

8-K

The emerging CRB-701 safety and efficacy data is showing differentiation from other experimental agents in HNSCC, and we are looking forward to continuing ...

EX-99.1

An ongoing Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors

Corbus Pharmaceuticals Reports Updated CRB-701 ...

CRB-701 was generally safe and well tolerated with discontinuation rates below 3%. About 50% of 2L head and neck cancer cases in the U.S. are ...

A phase 1/2 study of the next-generation nectin-4–targeting ...

The safety profile of CRB-701 was broadly consistent with earlier findings: keratitis, fatigue, alopecia, dysgeusia and anemia were the most ...

CRB-701 Shows Antitumor Activity in HNSCC

The safety profile of CRB-701 in patients with HNSCC was consistent with the overall safety population across all tumor types. The most common ...

CRB-701 Compared to Investigator's Choice Therapy in ...

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 ...

FDA Grants Fast Track Designation to CRB-701 in ...

The next-generation ADC, CRB-701, demonstrated an emerging objective response rate of 57% in a subgroup of patients with HNSCC.