Please note that pre- treatment and/or post -treatment tissue samples will only be collected if it poses limited risk to the patient. 9.0 STATISTICS Demographic data and disease -related characteristics will be summarized using descriptive statistics (count and percent, mean, median, standard deviation, minimum, maximum). Continuous variables will be presented by n, mean, median, standard deviation and range (min and max) as appropriate. Data will be presented by each dose cohort . All patient data, efficacy and safety data will be summarized. 9.1 Analysis Populations Safety Evaluable Population: All patients who received at least 1 dose of the study treatment . Efficacy Evaluable Population : All patients with pre- treatment measurable disease by RECIST 1.11, who had at least one radiological assessment after pre -treatment or discontinued study treatment early due to disease progression. 9.2 Endpoints 9.2.1 Primary • Safety and Tolerability: number of patients with TEAEs, SAEs, DLTs. 9.2.2 Secondary • Best overall response (CR, PR, SD) , overall survival, PFS per RECIST 1.1 1. 9.2.3 Exploratory • Immunological effect assessed by evaluating proportions of natural killer (NK) and T cell subsets for levels of activation, memory and exhaustion using flow cytometry . • Bioinformatics analysis of overexpressed CTAs and shared antigen expression with HS -110. • Immune reactivation response to HS-110 CTA -induced secretion of cytokines (e.g. by ELISPOT). 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 53 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page • Changes in pro -inflammatory serum cytokines and chemokines, as well as non -specific inflammatory markers (e.g. C -reactive protein). • Genomic, immunohistochemical and proteomic analysis of pre-treatment and on -treatment biopsy (collected from patients within 5 -14 days after 2nd dose of HS -130/HS -110) for exploratory biomarker analysis. • Immunologically active dose based on flow cytometry analysis of blood, using immune marker panels of activation and suppression as defined in Section 8.6.1 . 9.3 Safety Safety will be assessed by means of physical examination, weight, vital signs, performance status, laboratory evaluations (hematology, biochemistry , cytokines and chemokines ), electr ocardiogram (ECG) , and recording of concurrent illness/therapy and treatment-emergent adverse events. CTCAE version 5 will be used to grade all toxicities. Patients will also be monitored for any clinical symptoms associated with elevated cytokines levels. All related adverse events will be monitored until resolution. Patients will be monitored for safety and concomitant medications throughout the study. Safety data will be summarized for the safety evaluable population. These data will include AEs and laboratory parameters. Adverse event terms will be coded using the most current version of Medical Dictionary for Drug Regulatory Activities (MedDRA ®). 9.4 Efficacy Assessment of tumor response will be performed according to RECIST 1 .11. Patients will be evaluated after every 8 -week s ± 1-week for tumor response. Best overall response (CR, PR, SD) , OS and P FS will be dete rmined for each patient. 9.5 Exploratory/Other Studies Separate reports will be generated for the bioinformatics analysis of archived/fresh tissue samples, immune reactivation, changes in pro -inflammatory cytokines/ chemokines, and exploratory biomarker analysis of patient pre- treatment and on -treatment tumor tissue samples . 9.6 Sample Size This is an exploratory trial and therefore no sample size calculations have been performed. The number of pat ients (13 - 30 patients) is based on the planned n umber of dose escalation cohor ts required to identify the RP2D (defined as MTD or the highest feasible dose ). Based on response observed in patients at different dose levels and/or in patients with a particular tumor type, the study protocol may be amended to allow for cohort expansion of patients with specific characteristics. 10.0 QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES 10.1 Monitoring of the Study and Regulatory Compliance The Sponsor , or designee, will make an initiation site visit to each institution to review the protocol and its requirements with the Investigator(s), inspect the drug storage area, fully inform the Investigator of his/her responsibilities and the procedures for assuring adequate and correct documentation. During the 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 54 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page initiation site v isit, the case report forms (CRFs) will be reviewed. O ther pertinent study materials will also be reviewed with the Investigator’s research staff.