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CRB-601 monoclonal antibody

Phase 1

Solid Tumor | Small molecule | Oncology |Corbus Pharmaceuticals Holdings, Inc.|Last Updated: Jun 3, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment156

FDA Designations

No designations recorded

Clinical trial landscape

CRB-601 monoclonal antibody · 1 trial · 1 indication

Phase 1 1
NCT06603844First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.Solid Tumor
RECRUITING156 Analytics
PHASE1RECRUITING
First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurance of Dose-limiting toxicities
28 days
Characterize the safety of CRB-601 in combination anti-PD(L)1 therapy
6 months

Incidence of treatment emergent adverse events and clinically significant changes in laboratory parameters, ECG, vital signs and physical exam findings over treatment duration

To evaluate the efficacy of CRB-601 in terms of DCR when administered in combination with anti-PD(L)-1
6 months

Disease Control Rate (Complete Responses plus Partial Responses plus Stable Disease for at least 4 months as determined by the Investigator using RECIST 1.1.

Secondary Endpoints

To evaluate the preliminary antitumor activity of CRB-601 in combination with anti-PD(L)1 therapy
6 months
To characterize the PK profile of CRB-601
28 Days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Dose 1 CRB-601 monotherapyEXPERIMENTALDose 1 of CRB-601 (3mg/Kg) administered intravenously every two weeks
Part A: Dose 2 of CRB-601 monotherapyEXPERIMENTALDose 2 of CRB-601 (10mg/Kg) administered intravenously every two weeks
Part A: Dose 3 of CRB-601 monotherapyEXPERIMENTALDose 3 of CRB-601 (30mg/Kg) administered intravenously every two weeks
Part B/Cohort 1: Dose level (low) CRB-601 in combination with anti-PD(L)-1EXPERIMENTALDose (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed as per label.
Part B/Cohort 2: Dose level (high) CRB-601 in combination with anti-PD(L)-1EXPERIMENTALHigh dose CRB-601 (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label.
Part B/Expansion: Dose level (defined in Part B/ Safety Le) CRB-601 in combination with anti-PD(L)-1EXPERIMENTALDose (defined in Part B/ Safety Lead-In) or CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label.
Part C - Low dose CRB-601 in combination with anti-PD(L)-1EXPERIMENTALParticipants will receive a low dose of CRB-601 (defined in Part A \&B) in combination with standard of care dose of anti-PD(L)-1 therapy.
Part C - High dose CRB-601 in combination with anti-PD(L)-1EXPERIMENTALParticipants will receive a high dose of CRB-601 (defined in Part A \&B) in combination with standard of care dose of anti-PD(L)-1 therapy.

Interventions

NameTypeDescription
CRB-601 monoclonal antibodyDRUGCRB-601
Anti-PD-1 monoclonal antibodyDRUGAnti-PD(L)-1 used as per label
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available. * Measurable disease on imaging as assessed by RECIST 1.1 Eastern Coopera...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Recent Changes (Last 90 Days)

MEDIUMAug 1, 2026NCT06603844Phase: PHASE1/PHASE2 → PHASE1
MEDIUMAug 1, 2026NCT06603844Phase: PHASE1/PHASE2 → PHASE1
MEDIUMAug 1, 2026NCT06603844Phase: PHASE1/PHASE2 → PHASE1

Frequently asked questions about CRB-601 monoclonal antibody

What is CRB-601 monoclonal antibody used for?

CRB-601 monoclonal antibody is an investigational drug being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, with an ongoing first-in-human study evaluating its safety and tolerability in patients with advanced solid tumors.

Who makes CRB-601 monoclonal antibody?

CRB-601 monoclonal antibody is being developed by Corbus Pharmaceuticals Holdings, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol CRBP. The company is conducting clinical trials for this investigational oncology asset.

What phase is CRB-601 monoclonal antibody in?

CRB-601 monoclonal antibody is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to evaluate the drug in patients with advanced solid tumors.

What clinical trials is CRB-601 monoclonal antibody in?

CRB-601 monoclonal antibody is being studied in a Phase 1 clinical trial with the identifier NCT06603844. This first-in-human study is recruiting patients with advanced solid tumors in the United States and United Kingdom, with a planned enrollment of 156 participants.

Is CRB-601 monoclonal antibody the same as CRB-601-01?

CRB-601 monoclonal antibody is the drug being studied in the clinical trial titled 'First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.' The trial name refers to the drug as CRB-601-01, which appears to be the same investigational agent.