NCT06265727 · Corbus Pharmaceuticals Inc.
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
What this study is about
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.
View original scientific description
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 when used alone? 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 on its own.
Interventions
DRUG
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
DRUG
Anti-PD-1
checkpoint inhibitor
Primary outcome measures
Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701
Time frame: 21 days
Occurrence of Dose Limiting Toxicities as defined in the protocol
Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR)
Time frame: Up to 6 months
ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1
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
- Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed following at least one line of therapy or have no other standard therapy with proven clinical benefit.
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.
Where
- Birmingham, Alabama
- Duarte, California
- San Diego, California
- San Francisco, California
- Denver, Colorado
- New Haven, Connecticut
- Orlando, Florida
- Chicago, Illinois
- Hinsdale, Illinois
- Boston, Massachusetts
- Lincoln, Nebraska
- Huntersville, North Carolina
And 3 more locations — see the full list below.
Collaborators
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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 Jan 8, 2026 · Source of record for eligibility and locations