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

Summary

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.

Eligibility

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 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 Criteria:

* 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.

Conditions2

Locations20 sites

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