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

Launched by CORBUS PHARMACEUTICALS INC. · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called a Phase 1/2 study, is looking at a new treatment called CRB-701 for adults with solid tumors that express a protein known as nectin-4. The main goal is to find out what the safest and most effective dose of CRB-701 is when used alone, and to see which types of cancer might respond well to this treatment. To participate, individuals must have a confirmed diagnosis of specific advanced or metastatic solid tumors that have not improved after at least one other treatment or for which there are no effective standard options available.

If you join the trial, you will receive CRB-701 through an intravenous (IV) infusion in a clinic. During the study, you will undergo blood tests and imaging scans, like CT or MRI, to monitor how your tumors are responding to the treatment. It's important to note that not everyone can participate; individuals with certain medical conditions, such as uncontrolled brain metastases, severe neuropathy, or significant heart or liver issues, may be excluded. This study is currently recruiting participants, and they welcome people of all genders aged 18 and older who meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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.