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| Name | Class |
|---|---|
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | INDUSTRY |
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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.
This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4.
Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT.
Part B will evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors.
During Part C, the recommended dose level of CRB-701 for further exploration defined in Part B will explore CRB-701 alone or combined with anti-PD-1 in up to seven separate cohorts of participants with advanced tumors known to express Nectin-4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Dose Escalation - CRB-701 Dose Level 1 | Experimental | CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1 |
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| Part A Dose Escalation - CRB-701 Dose Level 2 | Experimental | CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1 |
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| Part A Dose Escalation - CRB-701 Dose Level 3 | Experimental | CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1 |
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| Part A Dose Escalation - CRB-701 Dose Level 4 | Experimental | CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1 |
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| Part B Dose Optimization: CRB-701 High dose | Experimental | Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1 |
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| Part B Dose Optimization: CRB-701 low dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRB-701 | Drug | Nectin-4 targeted Antibody Drug Conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A, B, & C: To characterize the safety profile of CRB-701 | Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v5.0 after single or multiple doses of CRB-701 or single and multiple doses of CRB-701 and an anti-PD-(L)1 therapy | Up to 6 months |
| Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ian Hodgson, PhD | Contact | +1 (617) 963-0105 | Clinical@Corbuspharma.com | |
| Rodney Carter, BSc | Contact | Clinical@Corbuspharma.com |
| Name | Affiliation | Role |
|---|---|---|
| David Pinato, MD | Imperial College London | Principal Investigator |
| Ian Hodgson, PhD | Corbus International Ltd | Study Director |
| Ari Rosenberg, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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A three part study
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Selected Low dose of CRB-701, intravenous infusion over 30 mins |
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| 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 |
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| Part C Dose Expansion - Cohort 2 | Experimental | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
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| 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 |
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| Part C Dose Expansion - Cohort 4 | Experimental | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
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| 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 |
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| 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 |
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| 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 |
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| Part C Dose Expansion - Cohort 6 | Experimental | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
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| 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 |
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| Anti-PD-1 | Drug | checkpoint inhibitor |
|
Maximum observed plasma concentration of total ADC after single and multiple doses |
| Approximately 9 weeks |
| Maximum observed plasma concentration of free MMAE (Cmax) | Maximum observed plasma concentration of free MMAE after single and multiple doses | Approximately 9 weeks |
| Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR) | DCR is the sum of percentage of participants meeting the definition of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 4 months using RECIST 1.1 | Up to 6 months |
| Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax) | Maximum observed plasma concentration of free MMAE after single and multiple doses | Approximately 9 weeks |
| Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax) | The amount of time to reach Cmax after single and multiple dose administration of CRB-701 (Total ADC) | Approximately 9 weeks |
| Time to reach Cmax of free MMAE (Tmax) | The amount of time to reach Cmax after single and multiple dose administration of free MMAE | Approximately 9 weeks |
| Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax) | The amount of time to reach Cmax after single and multiple dose administration of Tab | Approximately 9 weeks |
| Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax) | Maximum observed plasma concentration of free MMAE after single and multiple doses | Approximately 9 weeks |
| Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC) | Maximum observed plasma concentration of free MMAE after single and multiple doses | Approximately 9 weeks |
| Total Area Under the plasma concentration-time curve of free MMAE (AUC) | Area under the plasma concentration versus time curve after single and multiple dose administration of free MMAE | Approximately 9 weeks |
| Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC) | Area under the plasma concentration versus time curve after single and multiple dose administration of Tab | Approximately 9 weeks |
| University of Chicago |
| Principal Investigator |
| City of Hope Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| Moores Cancer Centre at UC San Diego Health | Recruiting | San Diego | California | 92037 | United States |
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| Helen Diller Family Comprehensive Cancer Center - UCSF | Recruiting | San Francisco | California | 94115 | United States |
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| Rocky Mountain Cancer Centres | Active, not recruiting | Denver | Colorado | 80218 | United States |
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Florida Cancer Specialists | Recruiting | Orlando | Florida | 32806 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Hope and Healing Cancer Center | Active, not recruiting | Hinsdale | Illinois | 60521 | United States |
| Dana-Faber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Nebraska Hematology Oncology | Active, not recruiting | Lincoln | Nebraska | 68506 | United States |
| Carolina BioOncology Institute | Active, not recruiting | Huntersville | North Carolina | 28078 | United States |
| Texas Oncology | Recruiting | Tyler | Texas | 75702 | United States |
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| Virginia Cancer Specialists | Active, not recruiting | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Center at University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
| ICM-Val d'Aurelle | Recruiting | Montpellier | 34298 | France |
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| CHU de Poitiers | Recruiting | Poitiers | 86000 | France |
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| Institut de Cancerologie de l'Ouest | Recruiting | Saint-Herblain | 44085 | France |
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| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
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| Careggi University Hospital | Recruiting | Florence | 50314 | Italy |
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| European Institute of Oncology IRCCS | Recruiting | Milan | 20141 | Italy |
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| Fondazione Policlinico Gemelli, IRCCS | Recruiting | Rome | 00168 | Italy |
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| Centro Richerche Cliniche di Verona | Recruiting | Verona | 37134 | Italy |
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| Institute of Oncology/ARENSIA Exploratory Medicine | Withdrawn | Chisinau | MD-2025 | Moldova |
| Aresnsia Research Clinic Bucharest | Recruiting | Bucharest | 22328 | Romania |
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| Aresnsia Research Clinic Cluj-Napoca | Recruiting | Cluj-Napoca | 400015 | Romania |
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| Centrul de Oncologie Sf. Nectarie | Recruiting | Iași | 200347 | Romania |
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| Centrul de Oncologie Euroclinic | Recruiting | Iași | 700106 | Romania |
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| Barcelona IOB Hospital Quironsalud (NEXT) | Recruiting | Barcelona | 08023 | Spain |
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| Vall d-Hebron Institut d'Oncologia | Recruiting | Barcelona | 08035 | Spain |
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| Fundacion Jimenez Diaz (START) | Recruiting | Madrid | 28040 | Spain |
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| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
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| University of Birmingham NHS Foundation Trust | Recruiting | Birmingham | B15 2TH | United Kingdom |
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| University of Cambridge NHS Foundation Trust | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
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| Velindre Cancer Centre | Recruiting | Cardiff | CF15 7QZ | United Kingdom |
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| Leeds University Hospitals NHS Trust | Recruiting | Leeds | LS9 7LP | United Kingdom |
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| Guy's and St Thomas' Clinical Research Facility | Recruiting | London | SE1 9RT | United Kingdom |
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| Imperial Experimental Cancer Medicine Centre | Recruiting | London | W12 0NN | United Kingdom |
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| The Christie Hospital | Recruiting | Manchester | M20 4BX | United Kingdom |
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| University of Liverpool - Clatterbridge Medical Centre | Recruiting | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
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| University of Southampton | Recruiting | Southampton | SO16 6YD | United Kingdom |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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