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

NCT06265727 · tracked via the Priya Life Science UK tracker

Sponsor

Corbus Pharmaceuticals Inc.

Phase

Phase 1/2

Started

2024-04-01

Last updated

2026-01-08

Condition(s) studied

Solid Tumor, Adult

Investigational drug(s) / intervention(s)

CRB-701Anti-PD-1

CRB-701: Nectin-4 targeted Antibody Drug Conjugate (ADC)

Anti-PD-1: checkpoint inhibitor

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 — 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) — Up to 6 months
ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1

Trial sites (41)

Facility	City	Region	Status
O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham	Birmingham	Alabama	Recruiting
City of Hope Cancer Center	Duarte	California	Recruiting
Moores Cancer Centre at UC San Diego Health	San Diego	California	Recruiting
Helen Diller Family Comprehensive Cancer Center - UCSF	San Francisco	California	Recruiting
Rocky Mountain Cancer Centres	Denver	Colorado	Active Not Recruiting
Yale Cancer Center	New Haven	Connecticut	Recruiting
Florida Cancer Specialists	Orlando	Florida	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
Hope and Healing Cancer Center	Hinsdale	Illinois	Active Not Recruiting
Dana-Faber Cancer Institute	Boston	Massachusetts	Recruiting
Nebraska Hematology Oncology	Lincoln	Nebraska	Active Not Recruiting
Carolina BioOncology Institute	Huntersville	North Carolina	Active Not Recruiting
Texas Oncology	Tyler	Texas	Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	Active Not Recruiting
Fred Hutchinson Cancer Center at University of Washington	Seattle	Washington	Recruiting
ICM-Val d'Aurelle	Montpellier	France	Recruiting
CHU de Poitiers	Poitiers	France	Recruiting
Institut de Cancerologie de l'Ouest	Saint-Herblain	France	Recruiting
Gustave Roussy	Villejuif	France	Recruiting
Careggi University Hospital	Florence	Italy	Recruiting
European Institute of Oncology IRCCS	Milan	Italy	Recruiting
Fondazione Policlinico Gemelli, IRCCS	Rome	Italy	Recruiting
Centro Richerche Cliniche di Verona	Verona	Italy	Recruiting
Institute of Oncology/ARENSIA Exploratory Medicine	Chisinau	Moldova	Withdrawn
Aresnsia Research Clinic Bucharest	Bucharest	Romania	Recruiting
Aresnsia Research Clinic Cluj-Napoca	Cluj-Napoca	Romania	Recruiting
Centrul de Oncologie Sf. Nectarie	Iași	Romania	Recruiting
Centrul de Oncologie Euroclinic	Iași	Romania	Recruiting
Barcelona IOB Hospital Quironsalud (NEXT)	Barcelona	Spain	Recruiting
Vall d-Hebron Institut d'Oncologia	Barcelona	Spain	Recruiting
Fundacion Jimenez Diaz (START)	Madrid	Spain	Recruiting
Hospital Clinico Universitario de Valencia	Valencia	Spain	Recruiting
University of Birmingham NHS Foundation Trust	Birmingham	United Kingdom	Recruiting
University of Cambridge NHS Foundation Trust	Cambridge	United Kingdom	Recruiting
Velindre Cancer Centre	Cardiff	United Kingdom	Recruiting
Leeds University Hospitals NHS Trust	Leeds	United Kingdom	Recruiting
Guy's and St Thomas' Clinical Research Facility	London	United Kingdom	Recruiting
Imperial Experimental Cancer Medicine Centre	London	United Kingdom	Recruiting
The Christie Hospital	Manchester	United Kingdom	Recruiting
University of Liverpool - Clatterbridge Medical Centre	Metropolitan Borough of Wirral	United Kingdom	Recruiting

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06265727 on ClinicalTrials.gov ↗ ← All trials in the UK