Hematological and no n-hematological ≤ Grade 2 unless considered non -acceptable. 2. Grade 3 self -limited or medically controllable toxicities (e.g., fever without ≥ Grade 3 neutropenia, nausea, vomiting, diarrhea, fatigue). 3. Electrolyte disturbances that are managed to Grade 1 or less with supplemental therapy. A DLT will be considered related to HS- 130/HS -110 treatment unless there is a clear, well-documented, alternative explanation for the AE. AEs that meet the above criteria, but occur after the DLT window of observation will not be defined as DLTs, but will be reported as AEs/Serious Adverse Events (SAEs), as applicable, and will be reviewed across all cohorts during the study to help inform dose escalation decisions. In case of suspicion of a DLT, the Investigator must info rm the Medical Monitor/Sponsor immediately. The DLT will be confirmed by the Medical Monitor/Sponsor and a decision must be taken by the Sponsor regarding if an ad hoc SRC meeting is required. Patients who are tolerating HS-130/HS -110 will not have to dis continue dosing prematurely due to 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 34 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page occurrence of DLTs in another patient in the same cohort, unless decided by the SRC. If requested by the Investigator, depending on the nature of the DLT and patient status, the SRC and the Sponsor may allow a patient to continue with study treatment at a reduced dose. 6.1.3 Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2 D) The definition of MTD will be based upon review of safety data and DLTs corresponding to the first two cycle s of therapy in at least 6 evaluable patients. MTD will be defined as a dose where 0 or 1 out of 6 patients have DLTs. The RP2 D may be equivalent to MTD OR the maximum feasible dose. The dose that is selected after this study for phase 2 evaluation may also be an immunologically active dose ( assessed based on flow cytometry analysis of blood, using immune marker panels of activation and suppression as defined in Section 8.6.1 ). 6.2 Dose Interruptions /Withholding Study drug may be withheld from a patient based on the Investigator‘ s decision in the event of intercurrent illness, adverse event, administrative reasons, or other reasons. If the patient‘s condition subsequently improves, or the situation that resulted in withholding study drug rectifies itself, the Investigator may resu me dosing as soon as possible, unless the delay is more than 2 -weeks. Doses should not be skipped. Dosing should be delayed for any DLT -equivalent toxicity and possible >Grade 2 adverse events considered related to study medicati on. At the I nvestigator’s discretion, dosing may recommence when the toxicity has resolved to G rade 2 or less. Immune related reactions or allergy should resolve t o Grade 1 or less. Treatment will be discontinued if the next cycle cannot be initiated if a TEAE has not resolved (to acceptable grade) after ≤2 weeks. Patients who miss a dose during Cycle 1 and Cycle 2 may be replaced in the study per Section 5.4.2 . The interrup tion and/or missed dose(s) should be recorded. 6.3 Dose Modification One level dose reduction per the dose escalation scheme, for toxicity is allowed. If the toxicity is equivalent to a DLT (see Section 6.1.2 ) then continued treatment at a lower dose level needs approval by the sponsor and/or SRC . 6.4 Concomitant Treatment Patients must not receive any other concurrent anti -cancer therapy, including investigational agents while on study treatment. Unexpected serious adverse reactions , including severe allergic reactions, may be treated according to standard -of-care and institutional practice without limita tions, including antihistamines, corticoste roids, cytokine antagonists, antipyretics and analgesics. 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 35 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page Supportive treatment may include anti -emetic, anti -diarrhea l, anti -pyretic, anti -histamines, analgesics, antibiotics, and blood products . At the discretion of the treating physician, patients may receive anti- histamine prophylaxis according to the standard of care in clinical practice. Local and/or systemic injection reactions may be treated with antihistamines, antipyretics, and/or analgesics in accordance with standard local practice and Investigator’s clinical judgment. For patients with bone metastases requiring medication for treatment and/or prevention of skeletal- related events bisphosphonates are permissible but RANK-ligand inhibitors are prohibited throughout the trial. While on treatment in the study, use of the type of medications specified below should be avoided.