UCI Health Cancer Center — Newport Clinical Trials

Breast - Neoadjuvant Newport PI Newport Sub-I CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status

HER-2 monoclonal Mahdavi UCI 14-67: A Phase II Study of Breast Cancer Treatment Using No prior treatment with , , , , Marlisse Ashley antibody Mehta Nabar Weekly Carboplatin + Paclitaxel with + (DS-8201a), or any other investigational Open to accrual Holbrook Chanthapadith VEGF monoclonal Nanci (HER2+) or (HER2-) in the Neoadjuvant Setting anti-HER2, anti-EGFR, or HER2 TKI agent or T-DM1. antibody Coluzzi

Breast - Adjuvant Newport PI Newport Sub-I CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status

S1418: A Randomized, Phase III Trial to Evaluate the Efficacy and Patients must have triple-negative breast cancer and not be Mahdavi Safety of MK-3475 as Adjuvant Therapy for Triple Receptor- planning to recieve adjuvant anti-HER2 or endocrine therapies after Nabar Marlisse Ashley Anti-PD-1 humanized Mehta Negative Breast Cancer with > 1 cm Residual Invasive Cancer or completion of neoadjuvant Open to accrual Nanci Holbrook Chanthapadith monoclonal antibody Positive Lymph Nodes (>pN1mic) After Neoadjuvant Residual disease must be ≥ 1 cm in greatest dimension, and/or have Coluzzi Chemotherapy positive lymph nodes (ypN+) observed on pathologic exam

•Post-menopausal female patients UCI 18-79: A Phase II Clinical Trial on Neo-Adjuvant •Histologically confirmed ER+ Breast Cancer Mahdavi with Fulvestrant in Patients with ER/PR + HER-2 Negative Breast CKD Inhibitor + Marlisse •Patients must have localized recurrence while on adjuvant Parajuli Nabar Linda Vo Cancer who Developed Localized Recurrence While on Adjuvant Neoadjuvant Endocrine Open to accrual Holbrook endocrine therapy Nanci Endocrine Therapy with Molecular Evidence of Endocrine Therapy •Patients must not have inflammatory breast cancer Coluzzi Resistance •No prior treatment with any CDK 4/6 inhibitor and/or Fulvestrant

Marlisse Holbrook (714)509-2803 Ashley Chanthapadith (714)509-2925 Ricardo Avalos (714)509-2495 Cindy Duong (714)509-2740 1 March 2021 UCI Health Cancer Center — Newport Clinical Trials

Breast - Metastatic HER2+ Newport Sub- Newport PI I CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status

resistance to antibody-mediated UCI 19-66: Randomized, Double-Blind, Phase III Study of Mahdavi inhibition using Patients must have history of prior treatment with a taxane Marlisse Tucatinib or Placebo in Combination with Ado-Trastuzumab Parajuli Nabar Linda Vo and trastuzumab in any setting, separately or in combination. Open to Accrual Holbrook Emtansine (T-DM1) for Subjects with Unresectable Locally- Nanci inhibitor and Prior pertuzumab therapy is allowed, but not required. Advanced or Metastatic HER2+ Breast Cancer Coluzzi antibody-based therapy

Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease Mahdavi NRG-BR004: A Randomized, Double-Blind, Phase III Trial of PD-L1 antibody + Marlisse including: de novo metastatic diseas without prior history of Parajuli Nabar Linda Vo Paclitaxel/Trastuzumab/Pertuzumab with or HER2 monoclonal Open to accrual Holbrook HER2-positive BC or locally recurrent or metastatic disease Nanci Placebo in First-Line HER2-Positive Metastatic Breast Cancer antibody following prior therapy for early BC Coluzzi

Breast - Metastatic HER2-

•HER2-, metastatic breast cancer •No more than one chemotherapy line in metastatic setting ETCTN 10287: A Randomized Phase I/II Trial of Fulvestrant •For patients enrolling on Phase E portion of the study: Mahdavi and Abemaciclib in Combination with Copanlisib (FAC) -Must have resistance to endocrine therapy in metastatic Marlisse Pan-class I PI3K Parajuli Nabar Linda Vo versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine- setting Pending Activation Holbrook inhibitor Nanci Resistant, Hormone Receptor Positive, HER2 Negative -No prior treatment w/ CDK 4/6 inhibitor, Fulvestrant, or PI3K Coluzzi Metastatic Breast Cancer inhibitor in metastatic setting -No brain metastasis

Triple Negative Breast Cancer

IgG1 monoclonal Nabar UCI 17-79: Phase 1b/2 study of SGN-LIV1A in combination antbody binding to Nanci Marlisse with for first-line treatment of patients with LIV-1 and linker in •Metastatic or locally-advanced triple-negative breast cancer Parajuli Linda Vo Open to accrual Mahavi Holbrook unresectable locally advanced or metastatic triple-negative lysosomes releasing •Have not previously received therapy for the treatment Coluzzi breast cancer MMAE which prevents cell division.

GI Newport PI Newport Sub-I CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status • Stage 0-III colon or rectal adenocarcinoma treated per SOC Eflornithine: S0820: A Double Blind Placebo-Controlled Trial of with resection alone or in combination with radiation or Ornithine Marlisse Eflornithine and Sulindac to Prevent Recurrence of High Risk chemotherapy Zell Dayyani Dorothy Chang decarboxylase (ODC) Open to accrual Holbrook Adenomas and Second Primary Colorectal Cancers in • Registration within 180-456 (inclusive) days of primary inhibitor; Sulindac: Patients with Stage 0-III Colon or Rectal Cancer, Phase III resection COX I/II inhibitor • NED (post-operative colonoscopy)

Marlisse Holbrook (714)509-2803 Ashley Chanthapadith (714)509-2925 Ricardo Avalos (714)509-2495 Cindy Duong (714)509-2740 2 March 2021 UCI Health Cancer Center — Newport Clinical Trials

Telephone Diet Prior history of rectosigmoid colon or rectal cancer with post- Zell S1820: A Randomized Phase II Trial of the Altering Intake, Modification surgical permanent ostomy or anastomosis. Last date of Marlisse Carmichael Dayyani Marlisse Holbrook Managing Symptoms (AIMS-RC) Intervention for Bowel Coaching (AIMS-RC) treatment for rectal cancer (surgery, chemo, RT) must be at Open to accrual Holbrook Lee Dysfunction in Rectal Cancer Survivors vs Telephone Health least 6 months, but not more than 24 months prior to Education registration

UCI 18-124: Phase 2 Study of Combined with •2nd or 3rd line treatment Zell Marlisse Cabozantinib and Dayyani Gwendolyn Ung Pembrolizumab in Metastatic Gastric and Gastroesophageal •Progression after at least one line of platinum FU-containing Open to accrual Lee Holbrook Pembrolizumab Adenocarcinoma regimen

• Undergone surgery for stage II or III colorectal cancer with Zell Marlisse UCI 20-03: BESPOKE Study of ctDNA Guided Therapy in ctDNA-guided available tissue and whole blood samples Dayyani Gwendolyn Ung Open to accrual Lee Holbrook Colorectal Cancer (CRC) therapy after surgery •Using SIGNATERA test, may be recommended for adjuvant chemotherapy or observation by treating physician

• Part A will enroll G/GEJ adenocarcinoma patients who have received no prior systemic treatment in the locally UCI 20-63: A Phase IIa, Multicenter, Open-Label Study of advanced/metastatic setting (first-line treatment); exclusion: HER2- DKN-01 in Combination with Tislelizumab ± Chemotherapy positive Zell Marlisse DKN-01 + Dayyani Krissy Ghio as First-Line or Second-Line Therapy in Adult Patients with • Part B will enroll patients who received only 1 prior systemic Open to accrual Lee Holbrook tislelizumab + CAPOX Inoperable, Locally Advanced or Metastatic Gastric or treatment, which must consist of a platinum + Gastroesophageal Junction Adenocarcinoma (DisTinGuish) fluoropyrimidine–based therapy (±HER2 therapy if applicable) for locally advanced/metastatic DKK1-high G/GEJ adenocarcinoma (second-line treatment)

UCI 20-77: An Open-Label, Multi-Center Phase I/II Dose Escalation and Expansion Study to Assess the Safety, •2nd or 3rd line treatment Zell Marlisse •Progression after at least one line of trastuzumab and/or Dayyani Cindy Duong Efficacy and of MRG002 in Patients with MRG002 Open to accrual Coluzzi Holbrook platinum/fluorpyrimidine IHC 2-3+/ISH-positive HER2expression, OR HER2-Positive Advanced Solid Tumors and Locally Advanced • IHC 1+, or IHC 2+/ISH-negative HER2 or Metastatic Gastric/Gastroesop

UCI 19-36: A Phase III, Randomized, Double-Blind, Placebo- Controlled, Multi-Center Study of Durvalumab: PD-L1 •HCC with completed curative therapy (resection or ablation) Marlisse Monotherapy or in Combination With Bevacizumab as inhibitor; •Patients must be randomized within 12 weeks of completing Dayyani Lee Krissy Ghio Pending Activation Holbrook Adjuvant Therapy in Patients With Hepatocellular Bevacizumab: VEGF curative therapy Carcinoma Who Are at High Risk of Recurrence After inhibitor •Child-Pugh A5-A6 Curative Hepatic Resection or Ablation (EMERALD-2)

UCI 19-37: A Phase III, Randomized, Double-Blind, Placebo- Controlled, Multicenter Study of Transarterial TACE + Durvalumab: •1st line treament •Imaging confirmed HCC Marlisse Chemoembolization (TACE) in Combination with either PD-L1 inhibitor + Dayyani Lee Krissy Ghio • Child-Pugh A-B7 Open to accrual Holbrook Durvalumab Monotherapy or Durvalumab plus Bevacizumab: VEGF •Vp1 and Vp2 portal vein thrombus allowed •Up Bevacizumab Therapy in Patients with Locoregional inhibitor to 4 TACE treatments allowed in 16-week period Hepatocellular Carcinoma (EMERALD-1)

Marlisse Holbrook (714)509-2803 Ashley Chanthapadith (714)509-2925 Ricardo Avalos (714)509-2495 Cindy Duong (714)509-2740 3 March 2021 UCI Health Cancer Center — Newport Clinical Trials

UCI 19-49: Phase II Study of Cabozantinib Combined with •Histologic or radiographic HCC diagnosis / and Transarterial Zell Marlisse Cabozantinib (TKI) + •Child-Pugj A-B7(B7 based on albumin allowed) Dayyani Cindy Duong Chemoembolization (TACE) in Patients with Hepatocellular Open to accrual Lee Holbrook Ipi/nivo (IO) + TACE •Not a candidate for resection or transplantion Carcinoma (HCC) Who are not Candidates for Curative •Must have at least Intent Treatment

•1st line systemic treatment UCI 20-79: A Phase Ib/II, Open-Label, Multicenter, Stage 1: Atezo/bev vs •Histology/Cytology confirmed locally advance or metastatic Randomized Umbrella Study Evaluating the Efficacy and atezo/bev + and/or unresectable HCC Zell Marlisse Dayyani Cindy Duong Safety of Multiple -Based Treatment tiragolumab vs •Child Pugh A Open to accrual Lee Holbrook Combinations in Patients with Advanced Liver Cancers atezo/bev + •Prior local therapy allowed(required:untreated measurable (Morpheus Liver) tocilizumab lesion or locally treated lesion must have progressed per RECIST

•1st line systemic treatment UCI 19-70: A Phase Ib/II, Open-Label, Study of in Marlisse Tivozanib, •Child Pugh A Lee Lee Krissy Ghio Combination with Durvalumab in Subjects with Untreated Pending Activation Holbrook durvalumab • Previous locoregional treatment: wash-out of 28 days prior Advanced Hepatocellular Carcinoma to enrollment

• Gastric: HER2-, chemotherapy-naïve • CRC (colorectal): microsatellite-stable, received up to 3 UCI 19-119: Phase 1/1b Study to Evaluate the Safety and prior systemic chemotherapy regimens TTX-030 (anti-CD39) + Marlisse Cindy Duong Activity of TTX-030 (Anti-CD39) in Combination with • RCC (renal): previously treated with up to 3 lines of prior Dayyani Nabar Anti-PD-1 and/or Open to accrual Holbrook Jasmine Balangue Budigalimab and/or Chemotherapy in Subjects with therapies Zell mFOLFOX6 Advanced Solid Tumors • HNSCC (head/neck): progression after checkpoint inhibitors • mCRPC (prostate): disease progression on recent prior systemic regimen, at least 2 prior systemic therapies

UCI 19-120: An Open-Label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, , Irinotecan liposome + •First line systemic metastatic pancreatic adenocarcinoma Marlisse 5-Fluorouracil/Leucovorin versus Nab-Paclitaxel Plus Dayyani Dayyani Jasmine Balangue oxaliplatin + 5-FU vs •Initial diagnosis of metatastic disease must have occurred Open to accrual Holbrook Gemcitabine in Subjects Who Have Not Previously Received Gem + Abraxane within < 6 from screening. Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

Neuro

1p/19q Co-deletion and IDH Mutation. Newly diagnosed and UCI 16-56: Phase II, Single Arm Study Of NOVOTTF-200A In Marlisse ≤ 3 months from surgical diagnosis. Bota Bota Drew Richard Bevacizumab-Naive Subjects With Recurrent WHO Grade III TTF device Open to accrual Holbrook Histological evidence of WHO grade III anaplastic glioma or Malignant Astrocytoma WHO grade II low grade glioma w

Heme Trials

Marlisse Holbrook (714)509-2803 Ashley Chanthapadith (714)509-2925 Ricardo Avalos (714)509-2495 Cindy Duong (714)509-2740 4 March 2021 UCI Health Cancer Center — Newport Clinical Trials

UCI 19-31: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of (MMB) versus Danazol PMF diagnosis, Symptomatic, defined as a MFSAF TSS of ≥ 10 (DAN) in Symptomatic, Anemic Subjects with Primary units assessed by a single MFSAF v4.0 assessment at Marlisse Selective inhibitor of Fleischman Fleischman Cody Slicker Myelofibrosis (PMF), Post- (PV) screening visit, anemic, Previously treated, with an approved Open to accrual Holbrook JAK1, JACK2 Myelofibrosis, or Post Essential Thrombocythemia (ET) JAK inhibitor for PMF or Post-PV/ET MF for ≥ 90 days, or ≥ 28 Myelofibrosis who were Previously Treated with JAK days of JAK inhibitor Inhibitor Therapy

ECOG-EA9161: A Randomized Phase III Study of the BCL2 inhibitor + BTK Must have newly diagnosed CLL according to the NCI/IWCLL Marlisse Addition of Venetolax to and O'Brien Fleischman Blake Johnson inhibitor +anti-CD20 criteria or SLL according to the WHO criteria. Age ≥ 18 years Open to accrual Holbrook versus Ibrutinib and Obinutuzumab in Untreated Younger monoclonal antibody and < 70. Patients with Chronic Lymphocytic Leukemia (CLL)

A041702: A Randomized Phase III Study of Ibrutinib Plus Marlisse Obinutuzumab Versus Ibrutinib Plus and BTK + BCL2 + CD20 O'Brien Brem Blake Slicker Must have newly diagnosed CLL to be eligible. Open to accrual Holbrook Obinutuzumab in Untreated Older Patients (>/= 70 years of antibody age) With Chronic Lymphocytic Leukeumia (CLL)

Correlative Trials

• Archival tumor tissue sample for central lab for MUC17 and UCI 19-55: A Non-Interventional Biomarker Study on the MUC17 and CLDN18.2 testing Dayyani Marlisse Dayanni Jasmine Balangue Molecular Evaluation of Archival Tumor Tissue in Subjects CLDN18.2 tissue • Locally advanced or metastatic gastric adenocarcinoma at Open to accrual Zell Holbrook with Gastric Cancer testing time of enrollment: T2-T4b/N0-3b/M0-M1 • See: UCI 19-56 for companion interventional study

Basket Trials

Newport PI Newport Sub-I CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status Marlisse Treatment based on Bota Bota Ricardo Avalos EAY131: Molecular Analysis for Therapy Choice Positive for specific mutations Open to accrual Holbrook mutations Bota Marlisse S1609: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Bota Mehir Tharani Immunotherapy Recurrent disease - Rare cancer Open to accrual Pinter-Brown Holbrook Tumors

Marlisse Holbrook (714)509-2803 Ashley Chanthapadith (714)509-2925 Ricardo Avalos (714)509-2495 Cindy Duong (714)509-2740 5 March 2021 UCI Health Cancer Center — Newport Clinical Trials

Correlative/Non-Treatment Trial PI Newport Sub-I Newport CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status Coluzzi UCI 17-43: Blood Collection Protocol for Circulating Tumor Patients must be female, at least 21 years of age or older, Nabar Marlisse Parajuli Linda Vo Cells and Circulating Cancer Associated Fibroblasts in Breast Blood Collection with histolocially confirmed breast cancer and be diagnosed Open to accrual Nanci Holbrook Cancer Patients as Stage III or IV. Must not have other active cancers. Mahdavi tumor heterogeneity and cell atlas Breast Cancer patients irrespective of the Hormonal or Her-2 Marlisse UCI 17-05: Understanding Intratumoral Heterogeneity Using delineating BRCA1- receptor expression status and across Stages I, II, III and IV Parajuli CRCs Only Chang Shim Open to accrual Holbrook Single Cell RNA Sequencing driven breast tumor who are BRCA 1 positive and will undergo breast or axillary initiation and node biopsy, definite surgery or prophylactic surgery (study progression in single group).

Positive SARS CoV-2 test within 14 days . C urrently Coluzzi undergoing treatment for cancer or had been within the past Nabar Marlisse NCICOVID: NCI COVID-19 in Cancer Patients Study O'Brien Carmen Lam n/a 6 weeks(includling chemotherapy, immunotherapy, Open to accrual Nanci Holbrook (NCCAPS): A Longitudinal Natural History Study monoclonal antibody therapy, target therapy, endocrine Mahdavi therapy, radiation therapy) or has rece

Supportive Care/Diagnostic

Newport Sub- Newport PI I CRC CRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status UCI 18-83: Pilot Study of Mirtazapine for the Dual Histologically confirmed diagnosis of glioma -No prior Marlisse Treatment of Depression and Temozolomide-Induced treatment with temozolomide TMZ -Patient will receive Bota Bota Ricardo Avalos Antidepressant Open to accrual Holbrook Nausea and Vomiting (CINV) in Newly-Diagnosed High- temozolomide TMZ therapy as part of their standard Grade Glioma Patients on Temozolomide Therapy treatment.

Marlisse Holbrook (714)509-2803 Ashley Chanthapadith (714)509-2925 Ricardo Avalos (714)509-2495 Cindy Duong (714)509-2740 6 March 2021