FDA Grants Designation to Investigational Drug for Head and Neck Cancer

The FDA has granted fast track designation to the investigational drug CRB-701 for recurrent or metastatic head and neck squamous cell carcinoma

The U.S. Food and Drug Administration (FDA) has granted fast track designation to an investigational drug known as CRB-701, potentially offering a new option to patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), according to a news release from Corbus Pharmaceuticals Holdings, Inc.

This designation applies to patients whose cancer has progressed after receiving platinum-based chemotherapy and an anti-PD(L)-1 therapy. Importantly, this is the second fast track designation the FDA has given to CRB-701, as it previously granted one for relapsed or refractory metastatic cervical cancer in 2024.

CRB-701 is a next-generation antibody-drug conjugate (ADC) that specifically targets a protein called Nectin-4, which is commonly found in certain cancers. It uses a cleavable linker and a controlled drug-to-antibody ratio, designed to deliver chemotherapy directly to cancer cells while limiting damage to healthy tissue. According to the news release, the fast track program aims to speed the development and review of treatments for serious diseases where an unmet medical need exists, which means CRB-701 may reach patients more quickly if future studies confirm its benefit.

Understanding the CRB-701 Clinical Trial

CRB-701 is currently being studied in an ongoing phase 1/2 trial for patients with advanced solid tumors that express Nectin-4. The trial is designed to evaluate safety, pharmacokinetics (how the drug moves through the body) and efficacy. Researchers first presented early dose escalation data earlier this year, and new findings on dose optimization will be shared at the European Society for Medical Oncology (ESMO) Congress in October 2025.

The study has three parts, according to information on the trial from clinicaltrials.gov. The first (Part A) tests escalating doses of CRB-701 to determine the maximum tolerated dose. The second (Part B) aims to identify the recommended phase 2 dose (RP2D), both as a single agent and in combination with an anti-PD-1 therapy. The third stage (Part C) will then expand testing in multiple cancer types using the established optimal dose. Patients enrolled receive CRB-701 through an intravenous infusion and undergo scans, blood tests and other assessments to measure how the drug affects their tumors.

To participate, patients must have advanced or metastatic solid tumors known to express Nectin-4 and must have progressed after at least one prior therapy. Certain conditions, such as uncontrolled central nervous system metastases, significant cardiovascular issues or severe neuropathy, can exclude patients from the study.

Head and Neck Cancer: What Patients Should Know

Head and neck cancer is a broad category that includes several cancers starting in areas such as the mouth, throat, voice box, nasal cavity and related structures, according to the Cleveland Clinic. Most are squamous cell carcinomas, which begin in the thin, moist lining of these regions. Treatment typically focuses on controlling the cancer while preserving essential functions like speech, swallowing and facial movement. Detecting and treating the disease early significantly improves the chances of a cure.

Specific subtypes of head and neck cancers include oral cancer, salivary gland cancer, nasal and sinus cancers, and cancers of the throat, tonsils and larynx. In the U.S., rates of tobacco-related head and neck cancers are declining, but HPV-related cases are increasing, especially in people under age 50. Globally, head and neck cancers represent approximately 4.5% of all cancer diagnoses.

With fast track designation and notable early study results, CRB-701 represents a potential new option for patients facing difficult-to-treat head and neck cancers, according to the news release. Additional trial data expected later this year will provide more insight into the drug’s safety and effectiveness.

References

1. “FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma,” by Corbus Pharmaceuticals Holdings, Inc. News release; Sept. 16, 2025.
2. “A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors.” clinicaltrials.gov. https://www.clinicaltrials.gov/study/NCT06265727
3. “Head and Neck Cancer,” by Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/14458-head-and-neck-cancer

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