Study termination. 5.4.1 Withdrawn Subjects When a patient is removed from the study, the Investigator will clearly document the reason in the medical record and complete the appropriate case report form describing the reason for discontinuation. In addition, every effort should be made to complete the appropriate assessments listed in Section 7.4. Patients lost to follow -up will be withdrawn from the study . Patients will be declared “lost to follow -up” if the last contact date has exceeded two years, and /or the site has documented three attempts to contact the patient by telephone and/or certified letter to last known address. 5.4.2 Replacement of Subjects Patients who discontinue due to t oxicity (related to study drug) during the 4 -week DLT window of observation of Cycle 1 and Cycle 2 , or who do not receive all doses due to toxicity in Cycle 1 and Cycle 2 , will not be replaced. Patients who discontinue or who do not receive at least two combination doses of HS-130/ HS-110 for any reason other than toxicity during Cycle 1 and 2 will be replaced. Note, that all patients who enrolled in the study will be included in assessment of DLT per Section 6.1.2 . 5.5 Study Stopping Criteria If any of the following occur, administration of HS -130/HS -110 will be temporarily or permanently stopped, pending a review by the Safety Review Committee . During that time, no drug can be administered to any patient, until a decision is made . • Any Death (o ther than progressive disease) that is at least possibly related to the study agent(s) • Occurrence of two or more grade 4 events that are at least possibly related to the study agent(s) 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 30 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page Conditions that may warrant trial termination are listed in Section 4.5 . 5.6 Noncompliance All instances of protocol deviations will be recorded according to the study specific monitoring plan. 6.0 TREATMENT OF SUBJECTS 6.1 Drug Preparation and Administration Both HS-130 and HS -110 drug product s will be administered via intradermal injections /re-injections based on the dose levels as defined in the dose escalation scheme (Section 6.1.1 ) on Day 1 of each cycle. If any serious adverse reaction occurs these may be treated per institutional practice, as noted in Section 6.4 Concomitant Medication. The HS-130 final drug product is packaged in single- dose vials as fully -diluted frozen liquid filled under aseptic conditions in 1.2 mL cryovials, containing 0.6 mL suspension of 2 x 10 7 cells/mL (targeted) in a cryopreservative buffer, with a final formulation of 0.567% sodium chloride, 0.5% human serum albumin (HSA) , 0.007% sodium bicarbonate, 6% pentastarch, and 5% dimethyl sulfoxide ( DMSO ). HS-110 ( viagenpumatucel -L) is packaged in single -dose vials as fully -diluted frozen liquid filled under aseptic conditions in 1.2 mL c ryovials, containing 0.6 mL suspension of 2 x 107 cell/mL (targeted) in a cryopreservative buffer, with a final formulation of 0.567% sodium chloride, 0.5% HSA, 0.007% sodium bicarbonate, 6% pentastarch, and 5% DMS O. Each patient will be administered up to a total of 10 spatially divided intradermal injections/re -injections of ≤ 0.14 mL per i njection, depending on the required HS -130 and HS -110 dose levels. HS-130 will be injected first, and a period of no less than 2 minutes , but no more than 5 minutes , should elapse before administering HS -110. HS -110 must be injected into the same exact lo cation as the HS -130 injections (re - injected sites). There are some dose levels (3, 5, 6, and 7) where the number of HS-110 injections will exceed the number of HS -130 injections. In these cases, after all HS-130 sites have been re -injected, the HS-110 may be administered in a new spatially divided injection site. At each cycle, the injection region will alternate between the left shoulder and right shoulder. T he HS - 130 and HS -110 injections will all be administered into the designated injection region for that cycle (left shoulder or right shoulder) to increase volume distribution and enhance antigen presentation to lymph node regions. 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 31 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page Table 1: HS-130/HS -110 Dose Administration Guidelines Volume (mL) per Injection Dose Level Study Drug Total mL Injection #1 Injection #2 Injection #3 Injection #4 Injection #5 Injection #6 Injection #7 -1 HS-130 0.02 0.02 HS-110 0.06 0.06 1 HS-130 0.04 0.04 HS-110 0.10 0.10 2 HS-130 0.10 0.10 HS-110 0.10 0.10 3 HS-130 0.10 0.10 HS-110 0.22 0.12 0.10 4 HS-130 0.18 0.10 0.08 HS-110 0.22 0.12 0.10 5 HS-130 0.18 0.10 0.08 HS-110 0.44 0.12 0.12 0.10 0.10 6 HS-130 0.36 0.12 0.12 0.12 HS-110 0.44 0.12 0.12 0.10 0.10 7 HS-130 0.36 0.12 0.12 0.12 HS-110 0.86 0.14 0.12 0.12 0.12 0.12 0.12 0.12 Drug product s will be supplied to clinical sites via shipments in liquid nitrogen dry-shipper units, which will be validated to maintain cryogenic temperatures for up to 10 days. Upon arrival, the product s will be transferred to controlled liquid nitrogen storage at the clinical site in the liquid nitrogen vapor phase until ready for preparation.