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Clinical Trials in Spain / NCT06265727
Recruiting Phase 1/2

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

NCT06265727 · tracked via the Priya Life Science Spain 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-701 →Anti-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
No
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)

FacilityCityRegionStatus
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.

More Corbus Pharmaceuticals Inc. trials in Spain

A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma Recruiting

Other trials for the same condition

A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours Recruiting
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors Recruiting
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer Recruiting
Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors Active, not recruiting
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Recruiting
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 Spain