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CRB-601 for Advanced Solid Tumors

This study is testing a new treatment called CRB-601, combined with an existing immunotherapy (anti-PD-1 monoclonal antibody), for people with advanced solid tumors. You might be eligible if your cancer has progressed after other treatments or if there are no other standard treatments available. CRB-601 works by targeting a protein called avb8 integrin, which is found on some cancers. Researchers want to find out how safe CRB-601 is, what dose works best, and if it can help shrink tumors or stop them from growing. They will be looking at side effects, how much CRB-601 is in your blood, and how your cancer responds over 6 months.

Study design
This is a first-in-human study with a planned enrollment of 156 participants. It is an interventional study, meaning participants will receive the study treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate safety and treatment effects for at least 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06603844

First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Corbus Pharmaceuticals Inc.
~156 participants
Updated 2025-06-03 on ClinicalTrials.gov
What's tested:CRB-601 monoclonal antibodyAnti-PD-1 monoclonal antibody

At a glance

Recruiting sites
4 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurance of Dose-limiting toxicities
Measured over 28 days
+2 more outcomes measured

Conditions

Solid Tumor

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Solid Neoplasm

NCT06603844

Where you'd take part

This study runs at 26 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advent Health Oncology Hematology

    Orlando, Floridastudy coordinator listed

    Not yet recruiting

  • Beatson West of Scotland Cancer Center

    Glasgow, United Kingdomstudy coordinator listed

    Not yet recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Not yet recruiting

  • Duke Cancer Center

    Durham, North Carolinastudy coordinator listed

    Not yet recruiting

  • Edinburgh Cancer Research Centre

    Edinburgh, United Kingdomstudy coordinator listed

    Not yet recruiting

  • Guys and St Thomas NHS Foundation Trust

    London, United Kingdomstudy coordinator listed

    Not yet recruiting

  • Nebraska Hematology Oncology

    Lincoln, Nebraskastudy coordinator listed

    Recruiting

  • SCRI - Arizona Oncology Associates

    Tucson, Arizonastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeff Clarke, MD · PRINCIPAL_INVESTIGATOR · Duke University, NC, USA
  • Christian Ottensmeier, MD · PRINCIPAL_INVESTIGATOR · Liverpool University, UK
  • Dominic Smethurst, MD · STUDY_DIRECTOR · Corbus Pharmaceuticals Inc.

Who to contact

Ian Hodgson, PhD
[email protected]
617-963-0100
Email the study team

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Eligibility criteria

Inclusion

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 Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.
Life expectancy of more than 12 weeks.
Adequate hematologic and end-organ function.

Exclusion

History of solid tumor malignancies other than the disease under study within 3 years of study enrollment
History of and/or current cardiovascular events or conditions
Chronic severe liver disease or liver cirrhosis
Systemic autoimmune disease
Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes.
Interstitial lung disease within 6 months of study enrollment.
Active or persistent infection
Other conditions that in the opinion of the Investigator would compromise the outcomes of the study.

What this trial measures

  • Occurance of Dose-limiting toxicities28 days
  • Characterize the safety of CRB-601 in combination anti-PD(L)1 therapy6 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)-16 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.