A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorbus Pharmaceuticals Inc.
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- CRB-701
- Anti-PD-1
Treatment groups
348 Participants
are divided into 15 treatment groups15
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Corbus Pharmaceuticals Inc.
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborator
Source ClinicalTrials.gov