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A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: CRB-701 (drug), Anti-PD-1 (drug)
How long the study runs: Study runs about 33 months (dates as stated)
About the drug or intervention: CRB-701 — drug: Nectin-4 targeted Antibody Drug Conjugate (ADC) · Anti-PD-1 — drug: checkpoint inhibitor
Patient visit burden: Not specified by the sponsor

In plain English

This early-stage study (Phase 1/2) is testing a new drug called CRB-701 in adults with certain advanced solid tumours (cancers) that carry a protein called nectin-4. The tumours must have grown worse after all suitable standard treatments, or no standard treatment with proven benefit is available. The study is funded by Corbus Pharmaceuticals Inc.

Who can take part

Adults with a confirmed diagnosis of certain advanced or spread (metastatic) solid tumours that show nectin-4, which have got worse after all suitable treatments, or where no standard treatment with proven benefit exists.
In Part C of the study, people with head and neck squamous cell cancer (HNSCC — a type of head and neck cancer) may join as their first treatment.

Who may not be able to

Cancer that has spread to the brain or spinal cord and is active or not controlled.
A history of other solid tumours besides the ones being studied.
Heart problems or events in the past 6 months.
Existing nerve damage (neuropathy) that is Grade 2 or worse.
Poorly controlled diabetes, a high HbA1C blood test (8% or more), or known diabetic nerve damage.
An active eye disease at the start of the study.
Long-term severe liver disease or scarring of the liver (cirrhosis).
Lung inflammation (interstitial lung disease or pneumonitis) within 6 months of starting study treatment.
Other significant health problems.

What taking part involves

• Not stated — ask the trial team.

Time commitment: Not stated — ask the trial team. The trial data does not say how long the study lasts or how many hospital visits are needed.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 348
Started: 2024-04-01
Last checked: 2026-01

Plain English Summary

What is this study?

• Testing a new treatment for solid tumor, adult
• Phase1/Phase2 - 348 participants
• The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4

Who can take part?

• Ages 18 Years and over
• Diagnosed with solid tumor, adult

Where?

• Birmingham - University of Birmingham NHS Foundation Trust
• Cambridge - University of Cambridge NHS Foundation Trust
• Cardiff - Velindre Cancer Centre
• Leeds - Leeds University Hospitals NHS Trust
• +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.

More detail

This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4. Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT. Part B will evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors. During Part C, the recommended dose level of CRB-701 for further exploration defined in Part B will explore CRB-701 alone or combined with anti-PD-1 in up to seven separate cohorts of participants with advanced tumors known to express Nectin-4.

Solid Tumor, Adult

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Who cannot take part

✗Active of uncontrolled CNS metastases
✗History of solid tumors other than the diseases under study
✗History of and/or current cardiovascular events or conditions in the previous 6 months
✗Pre-existing \>/= Grade 2 neuropathy
✗red blood cell level A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy

See the full criteria

Inclusion Criteria: * Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy. Exclusion Criteria: * Active of uncontrolled CNS metastases * History of solid tumors other than the diseases under study * History of and/or current cardiovascular events or conditions in the previous 6 months * Pre-existing \>/= Grade 2 neuropathy * Hemoglobin A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy * Active ocular disease at baseline * Chronic severe liver disease or live cirrhosis * Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study * Other significant cormorbidities.