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

NCT06265727 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CRB-701-01
• Study Type: interventional
• Target: 348
• Locations: 7 countries
• Sites: 41

Brief 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.

Conditions

Solid Tumor, Adult

Keywords

nectin-4

Outcome Measures

Primary Outcomes (2)

• Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701

  Occurrence of Dose Limiting Toxicities as defined in the protocol

  21 days

• Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR)

  ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1

  Up to 6 months

Secondary Outcomes (12)

• Parts A, B, & C: To characterize the safety profile of CRB-701

  Up to 6 months

• Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax)

  Approximately 9 weeks

• Maximum observed plasma concentration of free MMAE (Cmax)

  Approximately 9 weeks

• Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR)

  Up to 6 months

• Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax)

  Approximately 9 weeks

Study Arms (15)

Part A Dose Escalation - CRB-701 Dose Level 1

EXPERIMENTAL

CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1

Drug: CRB-701

Part A Dose Escalation - CRB-701 Dose Level 2

EXPERIMENTAL

CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1

Drug: CRB-701

Part A Dose Escalation - CRB-701 Dose Level 3

EXPERIMENTAL

CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1

Drug: CRB-701

Part A Dose Escalation - CRB-701 Dose Level 4

EXPERIMENTAL

CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1

Drug: CRB-701

Part B Dose Optimization: CRB-701 High dose

EXPERIMENTAL

Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1

Drug: CRB-701

Part B Dose Optimization: CRB-701 low dose

EXPERIMENTAL

Selected Low dose of CRB-701, intravenous infusion over 30 mins

Drug: CRB-701

Part C Dose Expansion - Cohort 1

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Drug: CRB-701; Drug: Anti-PD-1

Part C Dose Expansion - Cohort 2

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins

Drug: CRB-701

Part C Dose Expansion - Cohort 3

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Drug: CRB-701; Drug: Anti-PD-1

Part C Dose Expansion - Cohort 4

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins

Drug: CRB-701

Part C Dose Expansion - Cohort 5

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Drug: CRB-701; Drug: Anti-PD-1

Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1

EXPERIMENTAL

Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Drug: CRB-701; Drug: Anti-PD-1

Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1

EXPERIMENTAL

Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Drug: CRB-701; Drug: Anti-PD-1

Part C Dose Expansion - Cohort 6

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins

Drug: CRB-701

Part C Dose Expansion - Cohort 7

EXPERIMENTAL

Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Drug: CRB-701; Drug: Anti-PD-1

Interventions

CRB-701 DRUG

Nectin-4 targeted Antibody Drug Conjugate (ADC)

Part A Dose Escalation - CRB-701 Dose Level 1; Part A Dose Escalation - CRB-701 Dose Level 2; Part A Dose Escalation - CRB-701 Dose Level 3; Part A Dose Escalation - CRB-701 Dose Level 4; Part B Dose Optimization: CRB-701 High dose; Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1; Part B Dose Optimization: CRB-701 low dose; Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1; Part C Dose Expansion - Cohort 1; Part C Dose Expansion - Cohort 2; Part C Dose Expansion - Cohort 3; Part C Dose Expansion - Cohort 4; Part C Dose Expansion - Cohort 5; Part C Dose Expansion - Cohort 6; Part C Dose Expansion - Cohort 7

Anti-PD-1 DRUG

checkpoint inhibitor

Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1; Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1; Part C Dose Expansion - Cohort 1; Part C Dose Expansion - Cohort 3; Part C Dose Expansion - Cohort 5; Part C Dose Expansion - Cohort 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corbus Pharmaceuticals Inc.: lead
• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: collaborator

Study Sites (41)

O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

City of Hope Cancer Center

Duarte, California, 91010, United States

RECRUITING

Moores Cancer Centre at UC San Diego Health

San Diego, California, 92037, United States

RECRUITING

Helen Diller Family Comprehensive Cancer Center - UCSF

San Francisco, California, 94115, United States

RECRUITING

Rocky Mountain Cancer Centres

Denver, Colorado, 80218, United States

ACTIVE NOT RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Cancer Specialists

Orlando, Florida, 32806, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Hope and Healing Cancer Center

Hinsdale, Illinois, 60521, United States

ACTIVE NOT RECRUITING

Dana-Faber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Nebraska Hematology Oncology

Lincoln, Nebraska, 68506, United States

ACTIVE NOT RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

ACTIVE NOT RECRUITING

Texas Oncology

Tyler, Texas, 75702, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

ACTIVE NOT RECRUITING

Fred Hutchinson Cancer Center at University of Washington

Seattle, Washington, 98195, United States

RECRUITING

ICM-Val d'Aurelle

Montpellier, 34298, France

RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44085, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Careggi University Hospital

Florence, 50314, Italy

RECRUITING

European Institute of Oncology IRCCS

Milan, 20141, Italy

RECRUITING

Fondazione Policlinico Gemelli, IRCCS

Rome, 00168, Italy

RECRUITING

Centro Richerche Cliniche di Verona

Verona, 37134, Italy

RECRUITING

Institute of Oncology/ARENSIA Exploratory Medicine

Chisinau, MD-2025, Moldova

WITHDRAWN

Aresnsia Research Clinic Bucharest

Bucharest, 22328, Romania

RECRUITING

Aresnsia Research Clinic Cluj-Napoca

Cluj-Napoca, 400015, Romania

RECRUITING

Centrul de Oncologie Sf. Nectarie

Iași, 200347, Romania

RECRUITING

Centrul de Oncologie Euroclinic

Iași, 700106, Romania

RECRUITING

Barcelona IOB Hospital Quironsalud (NEXT)

Barcelona, 08023, Spain

RECRUITING

Vall d-Hebron Institut d'Oncologia

Barcelona, 08035, Spain

RECRUITING

Fundacion Jimenez Diaz (START)

Madrid, 28040, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

University of Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

RECRUITING

University of Cambridge NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Velindre Cancer Centre

Cardiff, CF15 7QZ, United Kingdom

RECRUITING

Leeds University Hospitals NHS Trust

Leeds, LS9 7LP, United Kingdom

RECRUITING

Guy's and St Thomas' Clinical Research Facility

London, SE1 9RT, United Kingdom

RECRUITING

Imperial Experimental Cancer Medicine Centre

London, W12 0NN, United Kingdom

RECRUITING

The Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

University of Liverpool - Clatterbridge Medical Centre

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

RECRUITING

University of Southampton

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Interventions

spartalizumab

Study Officials

• David Pinato, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Ian Hodgson, PhD

  Corbus International Ltd

  STUDY DIRECTOR

• Ari Rosenberg, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Hodgson, PhD

CONTACT

+1 (617) 963-0105; Clinical@Corbuspharma.com

Rodney Carter, BSc

CONTACT

Clinical@Corbuspharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A three part study

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): January 27, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); MO (1); RO (4); GB (9); US (15); FR (4); IT (4)