GI ONCOLOGY CLINICAL TRIALS AT UCDAVIS

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1 G ONCOLOGY CLNCAL TRALS AT UCDAVS Version: DECEMBER 2017 Please contact us with any questions or any potential clinical patients Edward Kim, MD/PhD pager: May Cho, MD pager:

2 PANCREAS adjuvant borderline locally (1st line) (2nd line) (2nd line and any stage Sensitivity to Oxaliplatin-Based Chemotherapy CCHO Pilot Study of Kernel-Based Dynamic 18F- Fludeoxyglucose Positron Emission Tomography (KBD FDG-PET) for Detection of Residual Disease in Patients with Borderline Resectable Pancreatic Adenocarcinoma Treated with Chemotherapy A Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas CanStem111P - A Phase Study of BB-608 plus nab- Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma. SWOG S Randomized Phase Study of 2nd Line FOLFR versus Modified FOLFR with PARP nhibitor ABT-888 (Veliparib) (NSC ) in Metastatic Pancreatic Cancer M A Multi-Center, Phase 1, Open Label, Dose Escalation Study of ABBV-428, an mmunotherapy in Subjects with Ph A Phase Study of Selumetinib (AZD6244) for the Treatment of Advanced Pancreas Cancer harboring KRAS G12R Mutations PAYLOAD RRx A Phase, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination with rinotecan in Metastatic or Advanced Cancer patients Without Life- Prolonging Therapies of Demonstrated Clinical Benefit PH-87: Phase Clinical Trial of VX-970 in Combination With the Topoisomerase nhibitor rinotecan in Patients With SM08502-ONC-01: A Phase 1, Open-Label, Dose- Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects with DART - Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors CCHO PAnDORA:Pancreatic ADenocarcinoma Organoids as a model system for correlative science ReseArch SBRT Napabucasin (BB-608) - STAT3 ABT PARP ABBV anti- CD40 and antimesothelin Selumetinib - MEK kinase pathway nivolumab/ipil umumab (SV 12/21/17) - currently in dose escalation SRC/RB borderline resectable borderline resectable - FOLFRNOX candidates untreated - gem/nab-paclitaxel candidate - 2nd line (excludes prior irinotecanbased therapy) pancreatic with KRAS G12R mutation irinotecan - UGT1A1 6/6 only rare pancreatic tumor histologies - NOT adenocarcinoma any patient undergoing biopsy or surgery Edward Kim Emily Schwab Edward Kim

3 COLORECTAL Adjuvant locally rectal (1st line) (2nd line and (chemo-naïve or chemorefractory) Sensitivity to Oxaliplatin-Based Chemotherapy A Randomized std adj chemo alone or combined with Atezo in stage MS high colon cancer NRG-G002 - A Phase Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer NRG-G004 - A Phase study of mfolfox6/bev with or without Atezolizumab or Atezolizumab monotherapy in 1st line treatment of patients with dmmr colorectal cancer PAYLOAD RRx A Phase, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination with rinotecan in Metastatic or Advanced Cancer patients Without Life- Prolonging Therapies of Demonstrated Clinical Benefit DART - Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors Atezolizumab (PDL1) FOLFOX x4m -> chemort -> s urgery Atezolizumab (PDL1) PH-87 - Phase Clinical Trial of VX-970 in Combination With the Topoisomerase nhibitor rinotecan in Patients With Advanced Solid kinase Tumors S1613- A randomized study of pertuzumab and Trastuzumab(TP) compared to Cetuximab and irinotecan (CETR) in colorectal cancer with HER2 amplification SM08502-ONC-01: A Phase 1, Open-Label, Dose- Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects with Advanced Solid Tumors UCDCC#241: Gastrointestinal Cancer Research Program-001: Advanced Colorectal Cancer Pathway protocol Pertuzumab and Trastuzumab pathway SRC in Jan SRC RB SRC/RB stage colon cancer with MS High Stage / locally rectal cancer stage V colon cancer with MS High irinotecan small bowel adenocarcinoma, squamous colorectal/small bowel, neuroendocrine carcinoma, undifferentiated - have to first screen through NC- MATCH stage V colorectal cancer with HER2 amplication before anti EGFR therapy any newly diagnosed patient (cohort A) or chemorefractory (cohort B) Heather Melanson Barbara Kavinsky

4 HCC and Biliary HCC HCC - 2nd Line after Sorafenib regis try Sensitivity to Oxaliplatin-Based Chemotherapy A 5-Year Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma KEYNOTE A Phase Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma pembrolizumab (PD-1) HCC pa ti ents Rad or Path confirmed - Progress ed or intolerant to Sorafenib - Child Pugh A only Chung Heng (Peter) Liu Unresectable or cholangio or GB - 1st line b HALO A Phase 1b, Randomized, Open- Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Hyaluronan- High (HA-high) Subjects with Previously Untreated, Unresectable, Locally Advanced, or Metastatic ntrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma atezolizumab (PDL-1) and PEGPH20 (hyaluronidase) (SV 12/15/17) untreated locally unresectable or intra-, extraheptic, and gallbladder. Gem cis candidate. cholangio or GB PAYLOAD RRx A Phase, Open- Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination with rinotecan in Metastatic or Advanced Cancer patients Without Life- Prolonging Therapies of Demonstrated Clinical Benefit PH-87: Phase Clinical Trial of VX-970 in Combination With the Topoisomerase nhibitor rinotecan in Patients With SM08502-ONC-01: A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects with kinase pathway SRC/RB irinotecan - UGT1A1 6/6 only / PMT4979g: An Open-label, Phase /, Dose- Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients with Locally Advanced or Metastatic Solid Tumors GDC P3K 2nd line LA or with PK3CA mutation unresectable cholangiocarci noma - 2nd or 3rd line NC A Randomized Phase 2 Study of Atezolizumab in Combination with Cobimetinib versus Atezolizumab Monotherapy in Participants with Unresectable Cholangiocarcinoma DART - Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors atezolizumab (PDL1 ) and Cobimetinib (MEK ) approved by UCD G DWG CRB temporarily 2nd/3rd line cholangiocarcionma cholangiocarcinoma

5 Esophageal and Gastric Sensitivity to Oxaliplatin-Based Chemotherapy GEJ/gastric 2nd/3rd Line b HALO A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined with Pembrolizumab in Subjects with Selected Hyaluronan-High Solid Tumors pembrolizumab (PD-1) and PEGPH20 (hyaluronidase) No more than 2 lines of therapy - if HER2+ progressed on herceptin - BOMARKER HA-high only gastric / PMT4979g: An Open-label, Phase /, Dose- Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients with Locally Advanced or Metastatic Solid Tumors GDC P3K 2nd line LA or with PK3CA mutation (2nd line and DART - Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors PH-87: Phase Clinical Trial of VX-970 in Combination With the Topoisomerase nhibitor rinotecan in Patients With SM08502-ONC-01: A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects with LYC A Phase 1/2A, Multicenter, Open-Label Study of LYC in Adult Subjects with Locally Advanced or Metastatic Cancer kinase pathway LYC T-cell activator SRC/RB squamous gastric or neuroendocrine carcinoma, undifferentiated adenocarcinoma of G track Gastric and Esophageal, 2nd, 3rd or 4th line, prior PD1 allowed Linh Dang-Chu