Solid Tumor, AdultPhase 1/2NCT06265727
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
A Phase 1/2 study testing CRB-701 and Anti-PD-1 in people with Solid Tumor, Adult, run by Corbus Pharmaceuticals Inc. at 41 sites in 7 countries.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- CRB-701 and Anti-PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 1 Apr 2024to 27 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Chronic severe liver disease or live cirrhosis
- Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
- Other significant cormorbidities.
Trial locations and contacts
41 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Rodney Carter, BSc contact
41 sites in 7 countries
United States15 sites, 10 recruiting
- Recruiting
O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham
Birmingham, Alabama, 35294
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Dana-Faber Cancer Institute
Boston, Massachusetts, 02215
Rodney Carter
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Rodney Carter, Clinical@corbuspharma.com
- Active, not recruiting
Rocky Mountain Cancer Centres
Denver, Colorado, 80218
- Recruiting
City of Hope Cancer Center
Duarte, California, 91010
Rodney Carter, Clinical@corbuspharma.com
- Active, not recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Active, not recruiting
Hope and Healing Cancer Center
Hinsdale, Illinois, 60521
- Active, not recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
- Active, not recruiting
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Florida Cancer Specialists
Orlando, Florida, 32806
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Moores Cancer Centre at UC San Diego Health
San Diego, California, 92037
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Helen Diller Family Comprehensive Cancer Center - UCSF
San Francisco, California, 94115
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Fred Hutchinson Cancer Center at University of Washington
Seattle, Washington, 98195
- Recruiting
Texas Oncology
Tyler, Texas, 75702
Rodney Carter, Clinical@corbuspharma.com
United Kingdom9 sites, 9 recruiting
- Recruiting
University of Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Rodney Carter, clinical@corbuspharma.com
- Recruiting
University of Cambridge NHS Foundation Trust
Cambridge, CB2 0QQ
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Velindre Cancer Centre
Cardiff, CF15 7QZ
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Leeds University Hospitals NHS Trust
Leeds, LS9 7LP
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Guy's and St Thomas' Clinical Research Facility
London, SE1 9RT
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Imperial Experimental Cancer Medicine Centre
London, W12 0NN
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
The Christie Hospital
Manchester, M20 4BX
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
University of Liverpool - Clatterbridge Medical Centre
Metropolitan Borough of Wirral, CH63 4JY
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
University of Southampton
Southampton, SO16 6YD
Rodney Carter, clinical@corbuspharma.com
France4 sites, 4 recruiting
- Recruiting
ICM-Val d'Aurelle
Montpellier, 34298
Rodney Carter, clinical@corbuspharma.com
- Recruiting
CHU de Poitiers
Poitiers, 86000
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Institut de Cancerologie de l'Ouest
Saint-Herblain, 44085
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Gustave Roussy
Villejuif, 94805
Rodney Carter, clinical@corbuspharma.com
Italy4 sites, 4 recruiting
- Recruiting
Careggi University Hospital
Florence, 50314
Rodney Carter, clinical@corbuspharma.com
- Recruiting
European Institute of Oncology IRCCS
Milan, 20141
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Fondazione Policlinico Gemelli, IRCCS
Rome, 00168
Carter, clinical@corbuspharma.com
- Recruiting
Centro Richerche Cliniche di Verona
Verona, 37134
Rodney Carter, clinical@corbuspharma.com
Romania4 sites, 4 recruiting
- Recruiting
Aresnsia Research Clinic Bucharest
Bucharest, 22328
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Aresnsia Research Clinic Cluj-Napoca
Cluj-Napoca, 400015
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Centrul de Oncologie Sf. Nectarie
Iași, 200347
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Centrul de Oncologie Euroclinic
Iași, 700106
Rodney Carter, clinical@corbuspharma.com
Spain4 sites, 4 recruiting
- Recruiting
Barcelona IOB Hospital Quironsalud (NEXT)
Barcelona, 08023
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Vall d-Hebron Institut d'Oncologia
Barcelona, 08035
Rodney Carter, clinical@corbuspharma.com
- Recruiting
Fundacion Jimenez Diaz (START)
Madrid, 28040
Rodney Carter, Clinical@corbuspharma.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Rodney Carter, Clinical@corbuspharma.com
Moldova1 site
- Withdrawn
Institute of Oncology/ARENSIA Exploratory Medicine
Chisinau, MD-2025
About this study
Official title: A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors
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.
Read the detailed description
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- CRB-701, Anti-PD-1
- Keywords
- nectin-4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRB-701Drug
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1Drug
checkpoint inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation - CRB-701 Dose Level 1 | Experimental | CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: CRB-701 |
| Part B Dose Optimization: CRB-701 low dose | Experimental | Selected Low dose of CRB-701, intravenous infusion over 30 mins Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: CRB-701; Drug: Anti-PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 6 months
Secondary outcomes (12)
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
Measured: Up to 6 months
Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax)
Maximum observed plasma concentration of total ADC after single and multiple doses
Measured: Approximately 9 weeks
Maximum observed plasma concentration of free MMAE (Cmax)
Maximum observed plasma concentration of free MMAE after single and multiple doses
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Approximately 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Apr 2024
- Primary completion16 Jan 2027 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A three part study
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pinato, MD, Principal investigator, Imperial College LondonIan Hodgson, PhD, Study director, Corbus International LtdAri Rosenberg, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265727
- Sponsor's protocol ID
- CRB-701-01
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06265727
- Acronym / sponsor ID
- CRB-701-01
- Conditions
- Solid Tumor, Adult
- Keywords
- nectin-4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 16 Jan 2027 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 15
- Model description
- A three part study
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation - CRB-701 Dose Level 1 | Experimental | Drug: CRB-701CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1 |
| Part A Dose Escalation - CRB-701 Dose Level 2 | Experimental | Drug: CRB-701CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1 |
| Part A Dose Escalation - CRB-701 Dose Level 3 | Experimental | Drug: CRB-701CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1 |
| Part A Dose Escalation - CRB-701 Dose Level 4 | Experimental | Drug: CRB-701CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1 |
| Part B Dose Optimization: CRB-701 High dose | Experimental | Drug: CRB-701Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1 |
| Part B Dose Optimization: CRB-701 low dose | Experimental | Drug: CRB-701Selected Low dose of CRB-701, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 1 | Experimental | Drug: CRB-701, Drug: Anti-PD-1Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part C Dose Expansion - Cohort 2 | Experimental | Drug: CRB-701Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 3 | Experimental | Drug: CRB-701, Drug: Anti-PD-1Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part C Dose Expansion - Cohort 4 | Experimental | Drug: CRB-701Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 5 | Experimental | Drug: CRB-701, Drug: Anti-PD-1Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1 | Experimental | Drug: CRB-701, Drug: Anti-PD-1Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1 | Experimental | Drug: CRB-701, Drug: Anti-PD-1Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part C Dose Expansion - Cohort 6 | Experimental | Drug: CRB-701Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 7 | Experimental | Drug: CRB-701, Drug: Anti-PD-1Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRB-701Nectin-4 targeted Antibody Drug Conjugate (ADC) | Drug | 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-1checkpoint inhibitor | Drug | 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 |
Primary outcome
Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701
Time frame: 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)
Time frame: Up to 6 months
ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1
12 secondary outcomes
Parts A, B, & C: To characterize the safety profile of CRB-701
Time frame: Up to 6 months
Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax)
Time frame: Approximately 9 weeks
Maximum observed plasma concentration of free MMAE (Cmax)
Time frame: Approximately 9 weeks
Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR)
Time frame: Up to 6 months
Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax)
Time frame: Approximately 9 weeks
Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax)
Time frame: Approximately 9 weeks
Time to reach Cmax of free MMAE (Tmax)
Time frame: Approximately 9 weeks
Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax)
Time frame: Approximately 9 weeks
Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax)
Time frame: Approximately 9 weeks
Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC)
Time frame: Approximately 9 weeks
Total Area Under the plasma concentration-time curve of free MMAE (AUC)
Time frame: Approximately 9 weeks
Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC)
Time frame: Approximately 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodney Carter, BSc contact
David Pinato, MD principal investigator
Imperial College London
Ian Hodgson, PhD study director
Corbus International Ltd
Ari Rosenberg, MD principal investigator
University of Chicago
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRB-701 and Anti-PD-1 in people with Solid Tumor, Adult, run by Corbus Pharmaceuticals Inc. at 41 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, United Kingdom, France, Italy, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Hodgson, PhD (+1 (617) 963-0105, Clinical@Corbuspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.