First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.
Public ClinicalTrials.gov record NCT06603844. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody Against Integrin avb8, in Patients With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein. Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer. Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy. There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.
Study identification
- NCT ID
- NCT06603844
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 156 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 3, 2024
- Primary completion
- Oct 31, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Jun 2, 2025
2024 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Not yet recruiting |
| SCRI - Arizona Oncology Associates | Tucson | Arizona | 85711 | Not yet recruiting |
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | Not yet recruiting |
| UC San Diego Health - Moores Cancer Center | La Jolla | California | 92093 | Not yet recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 99048 | Not yet recruiting |
| University of California San Francisco | San Francisco | California | 94143 | Not yet recruiting |
| SCRI - Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | Not yet recruiting |
| Advent Health Oncology Hematology | Orlando | Florida | 32804 | Not yet recruiting |
| SCRI- Lake Nona DDU | Orlando | Florida | 32827 | Recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Not yet recruiting |
| SCRI - Minnesota Oncology Hematology | Maple Grove | Minnesota | 55369 | Not yet recruiting |
| Nebraska Hematology Oncology | Lincoln | Nebraska | 68506 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Not yet recruiting |
| University Hospital of Cleveland (Case Western) | Cleveland | Ohio | 44106 | Not yet recruiting |
| SCRI - OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Not yet recruiting |
| SCRI - Nashville | Nashville | Tennessee | 37203 | Recruiting |
| START - San Antonio | San Antonio | Texas | 78229 | Recruiting |
| SCRI- Texas Oncology | Tyler | Texas | 75702 | Not yet recruiting |
| SCRI - Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Not yet recruiting |
| SCRI - Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06603844, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06603844 live on ClinicalTrials.gov.