During the course of the study, the monitor will make regular site visits in order to review protocol compliance, examine CRFs and individual subject’s medical records and assure that the study is being conducted according to pertinent regulatory requirements. All CRF entries will be verified with source documentation according to the study monitoring plan . The review of medical records will be done in a manner to assure that patient confidentiality is maintained. 10.2 Curricula Vitae and Financial Disclosure of Investigators All Principal Investigators will be required to provide a current signed and dated curriculum vitae, a completed FDA Form 1572 and a financial disclosure statement to Sponsor , or designee . All Sub- Investigators will be required to provide a current curricul um vitae and a financial disclosure statement to Sponsor or designee . 10.3 Protocol Modifications No modification of the protocol should be implemented without the prior written approval of the Sponsor or the Sponsor’s representative. Any such changes which may affect a patient’s treatment or informed consent, especially those increasing potential risks, must receive prior approval by the IRB/IEC. The exception to this is where modifications are necessary to eliminate an immediate hazard to trial subjec ts, or when the change involves only logistical or administrative aspects of the trial (e.g. , change in monitor, change in telephone number). Other administrative revisions which may impact the clinical portion of a study will be duly reported to the IRB/IEC by the Principal Investigator. 10.4 Publication Policy The publication of the results of the study will be subject to the terms and conditions of the clinical trial agreement between the Sponsor and Investigators. Sponsor approval is required for publicati on of any data from this trial. 11.0 ETHICAL CONSIDERATIONS 11.1 Informed Consent The Investigator will obtain written informed consent from each patient, or their authorized representative, participating in the study. The form must be signed, witnessed and dated. The informed consent form will contain all the Essential Elements of Informed Consent set forth in 21 CFR, Part 50, the European Union Directive 2001/20/EC and its associated Detailed Guidances, European Union GCP Directive 2005/28/EC, the ICH Guideline f or Good Clinical Practice, Section 4.8, and the terms of the Declaration of Helsinki ( 2013). Copies of the signed document should be given to the patient and filed in the Investigator’s study file, as well as the patient’s medical record if in conformance with the institution’s Standard Operating Procedures. 11.2 Institutional Review Board/Independent Ethics Committee The study will not be initiated without approval of the appropriate Institutional Review Board/Independent Ethics Committee (IRB/IEC) and compli ance with all administrative requirements of the governing body of the institution. This protocol, consent procedures, and any amendments must be 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 55 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page approved by the IRB/IEC in compliance with current regulations of the FDA and the European Union as applicabl e and in accordance with ICH/GCPs. A letter of approval will be sent to the Sponsor prior to initiation of the study and when any subsequent modifications are made.