Patients should have lesions that are safely accessible for biopsy and be willing to provide pre - treatment and on -treatment tissue biopsy. Fine -needle aspiration biopsy is not acceptable. Archival Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 27 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page tumor tissue will be accepted in lieu of fresh biopsy at screening if sample was collected within 6 - months from Cycle 1 Day 1, and the local pathologist confirms that an adequate amount of tissue/tumor cells exist to allow completion of all testing as outlined in the specimen collection manual. 3.