Summary
The purpose of this study is to evaluate the safety and tolerability of an investigational drug called KZR-261 when given via intravenous (IV) infusion for advanced solid tumor cancer. In Part 1 of the study, increasing doses of KZR-261 will be given to assess the safety and tolerability of KZR-261 for future research. Part 2 of the study will start to examine possible early anti-cancer activity of KZR-261 in patients who have certain types of cancers, such as melanoma, prostate cancer, colon cancer, mesothelioma (cancer of the lining of the lungs), or other organs. KZR-261 is an inhibitor of protein secretion, which means it blocks the release of proteins from inside both cancer and normal cells. The protein secretion pathway is being studied as a potential anti-cancer mechanism.
Inclusion Criteria
- Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system [CNS] neoplasms), defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered to result in reasonable clinical benefit).
- Disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the Investigator's judgement likely to result in clinical benefit, or if such therapy has been refused by the subject. Documentation of the reason must be provided for subjects who have not received a standard therapy likely to result in clinical benefit.
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
- Adequate baseline hematologic and organ function.
Study Location(s)
- Cedars-Sinai Cancer at Beverly Hills (THO)
- Cedars-Sinai Cancer at SOCC
- Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
More about this Clinical Trial
Full Title
KZR-261-101: A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies