3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-Affinity Natural Killer (HaNK) Cell Therapy With Adenoviral And Yeast-Based Vaccines To Induce T-Cell Responses In Subjects With Advanced, Unresectable, And Untransplantable HCC [NCT03563170]

Main Inclusion Criteria:
  • Histologically-confirmed advanced, unresectable and untransplantable HCC
  • Have at least 1 measurable lesion of ≥ 1.0 cm
  • Child-Pugh class A only

2.025: NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using A Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects With Previously Treated Cancer [NCT03552718]

Main Eligibility Criteria:
  • Histologically-confirmed solid cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
  • Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple- negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.

3.013: Phase I Study Of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) In Subjects With Unresectable Locally Advanced Or Metastatic HER2- Expressing (IHC 1+/2+/3+) Cancer [NCT02751528]

Main Eligibility Criteria:
  • Histologically confirmed unresectable locally advanced or metastatic cancer that expresses HER2 (IHC 1+, 2+, or 3+), derived from the most recent metastatic biopsy sample available.
  • Concurrent hormone therapy is permitted.
  • Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
  • Subjects cannot have ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
  • Subjects cannot have concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.

3.014: A Phase I Trial Of ABI-011 Administered Weekly In Patients With Advanced Solid Tumors Or Lymphomas [NCT02582827]

Main Inclusion Criteria:
  • Cytologically or histologically-confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
  • During the dose-escalation phase, measurable or non-measurable disease as defined by RECIST criteria Version 1.1.

3.028: Open-Label, Phase 1 Study Of HaNKTM For Infusion In Subjects With Metastatic Or Locally Advanced Solid Tumors [NCT03027128]

Main Inclusion Criteria:
  • Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy.
  • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
  • Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed.

3.036: A Phase 2 Study Of AMG 337 In Subjects With Advanced Or Metastatic Solid Tumors That Overexpress MET Or Harbor MET Exon 14 Skipping (METex14del) Mutations [NCT03147976]

Main Inclusion Criteria:
  • Histologically confirmed, unresectable locally advanced or metastatic solid tumor that overexpresses tumor MET (MET protein expression ≥ 1,000 attomole/μg of tumor tissue, as determined by quantitative proteomics with mass spectrometry [cohort 1]) or harbor METex14del mutations resulting in MET exon 14 skipping (as determined by DNA sequencing and confirmed with RNA sequencing [cohort 2]).
  • Have measurable disease evaluable in accordance with RECIST Version 1.1.