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

Condition(s) studied

Investigational drug(s) / intervention(s)

CRB-601 monoclonal antibody: CRB-601

Anti-PD-1 monoclonal antibody: Anti-PD(L)-1 used as per label

Study 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

Primary outcome measure(s)

• 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.

Trial sites (26)

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