UCI Health Cancer Center — Newport Clinical Trials

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

A011801: The COMPASSHER2 Trials (Comprehensive Use of Nabar Pathologic Response Assessment to Optimize Therapy in Patients must have HER2+ breast cancer with residual disease anti-PD-1 inhibitor Parajuli Mehta Elizabeth Afu Jacqueline Nguyen HER2-Positive Breast Cancer): COMPASSHER2 Residual after NACT Open to accrual (immunotherapy) Nanci Disease (RD), A Double-Blinded, Phase III Randomized Trial No prior treatment with TDM-1 of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

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

J Nguyen 456-6264, D Chang 509-2199 A Chanthapadith 509-2925, K Ghio 456-6528 C Duong 509-2740, B Huynh 509-6233 J Balangue 509-2948, C Lam 509-2718 A Vargas 509-2698, M Tharani 509-2643 E Afu 506-0471, E Khorram 509-2370

August 2021 UCI Health Cancer Center — Newport Clinical Trials

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

UCI 19-66: Randomized, Double-Blind, Phase III Study of resistance to antibody-

Tucatinib or Placebo in Combination with Ado- mediated inhibition using Patients must have history of prior treatment with a taxane Nabar Elizabeth Ashley Parajuli Trastuzumab Emtansine (T-DM1) for Subjects with tyrosine kinase inhibitor and trastuzumab in any setting, separately or in combination. Open to Accrual Nanci Afu Chanthapadith Unresectable Locally-Advanced or Metastatic HER2+ and antibody-based Prior pertuzumab therapy is allowed, but not required. Mehta Breast Cancer therapy

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

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 •For patients enrolling on Phase E portion of the study: Fulvestrant and Abemaciclib in Combination with -Must have resistance to endocrine therapy in metastatic Elizabeth Ashley Parajuli Nabar Copanlisib (FAC) versus Fulvestrant and Abemaciclib Pan-class I PI3K inhibitor setting Suspended Afu Chanthapadith Nanci Alone (FA) for Endocrine-Resistant, Hormone Receptor -No prior treatment w/ CDK 4/6 inhibitor, Fulvestrant, or PI3K Mehta Positive, HER2 Negative Metastatic Breast Cancer inhibitor in metastatic setting -No brain metastasis

Triple Negative Breast Cancer

August 2021 UCI Health Cancer Center — Newport Clinical Trials

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

• Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon with at least 12 lymph nodes Nabar NRG-GI005: Phase II/III Study of Circulating Tumor DNA examined at the time of surgical resection Cho Elizabeth ctDNA as prognostic Zell Kristian Ghio as a Predictive Biomarker in Adjuvant Chemotherapy in • Appropriate for active surveillance (i.e., no adjuvant Open to accrual Jafari Afu biomarker Patients with Stage IIA Colon Cancer (COBRA) chemotherapy) at the discretion of the evaluating oncologist Neumann based on current practice patterns

• Stage 0-III colon or rectal adenocarcinoma treated per SOC S0820: A Double Blind Placebo-Controlled Trial of Nabar Eflornithine: Ornithine with resection alone or in combination with radiation or Eflornithine and Sulindac to Prevent Recurrence of High Cho Elizabeth decarboxylase (ODC) chemotherapy Zell Dorothy Chang Risk Adenomas and Second Primary Colorectal Cancers Open to accrual Jafari Afu inhibitor; Sulindac: COX I/II • Registration within 180-456 (inclusive) days of primary in Patients with Stage 0-III Colon or Rectal Cancer, Mills inhibitor resection Phase III • NED (post-operative colonoscopy)

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

UCI 18-124: Phase 2 Study of Cabozantinib Combined •2nd or 3rd line treatment neumann Elizabeth Cabozantinib and Dayyani Kristian Ghio with Pembrolizumab in Metastatic Gastric and •Progression after at least one line of platinum FU-containing Open to accrual cho Afu Pembrolizumab Gastroesophageal Adenocarcinoma regimen Elquza

Cho • Undergone surgery for stage II or III colorectal cancer with Elquza Elizabeth UCI 20-03: BESPOKE Study of ctDNA Guided Therapy in ctDNA-guided therapy available tissue and whole blood samples Dayyani Baoan Huynh Open to accrual Mills Afu Colorectal Cancer (CRC) after surgery •Using SIGNATERA test, may be recommended for adjuvant Nanci chemotherapy or observation by treating physician Neumann

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

August 2021 UCI Health Cancer Center — Newport Clinical Trials

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

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

Abi-jaoudeh Boyd UCI 19-49: Phase II Study of Cabozantinib Combined •Histologic or radiographic HCC diagnosis Elquza with Ipilimumab/Nivolumab and Transarterial Imagawa Elizabeth Cabozantinib (TKI) + •Child-Pugj A-B7(B7 based on albumin allowed) Dayyani Cindy Duong Chemoembolization (TACE) in Patients with Open to accrual Jutric Afu Ipi/nivo (IO) + TACE •Not a candidate for resection or transplantion Hepatocellular Carcinoma (HCC) Who are not Katrivesis •Must have at least Long Candidates for Curative Intent Treatment Wolf

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

Abi-Jaoudeh Cho •1st line systemic treatment UCI 19-70: A Phase Ib/II, Open-Label, Study of Tivozanib Imagawa Elizabeth •Child Pugh A Dayyani Kristian Ghio in Combination with Durvalumab in Subjects with Tivozanib, durvalumab Open to accrual Jutric Afu • Previous locoregional treatment: wash-out of 28 days prior Untreated Advanced Hepatocellular Carcinoma Neumann to enrollment Wolf

August 2021 UCI Health Cancer Center — Newport Clinical Trials

• Gastric: HER2-, chemotherapy-naïve • CRC (colorectal): microsatellite-stable, received up to 3 prior UCI 19-119: Phase 1/1b Study to Evaluate the Safety systemic chemotherapy regimens Nabar Elizabeth Cindy Duong and Activity of TTX-030 (Anti-CD39) in Combination with TTX-030 (anti-CD39) + Anti- • RCC (renal): previously treated with up to 3 lines of prior Dayyani Cho Open to accrual Afu Jasmine Balangue Budigalimab and/or Chemotherapy in Subjects with PD-1 and/or mFOLFOX6 therapies Neumann 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

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

Neuro Castillo 1p/19q Co-deletion and IDH Mutation. Newly diagnosed and Chow UCI 16-56: Phase II, Single Arm Study Of NOVOTTF-200A Elizabeth ≤ 3 months from surgical diagnosis. Bota Hsu Esterliza Khorram In Bevacizumab-Naive Subjects With Recurrent WHO TTF device Open to accrual Afu Histological evidence of WHO grade III anaplastic glioma or Myung Grade III Malignant Astrocytoma WHO grade II low grade glioma w Turner Heme Trials

A041702: A Randomized Phase III Study of Ibrutinib Plus Nabar Obinutuzumab Versus Ibrutinib Plus Venetoclax and Nanci Elizabeth BTK + BCL2 + CD20 O'Brien Kristen Mueller Obinutuzumab in Untreated Older Patients (>/= 70 Must have newly diagnosed CLL to be eligible. Open to accrual Mahdavi Afu antibody Pinter-Brown years of age) With Chronic Lymphocytic Leukeumia (CLL)

August 2021 UCI Health Cancer Center — Newport Clinical Trials

Correlative Trials

Cho • Archival tumor tissue sample for central lab for MUC17 and Lee UCI 19-55: A Non-Interventional Biomarker Study on the CLDN18.2 testing Elizabeth MUC17 and CLDN18.2 Dayanni Neumann Jasmine Balangue Molecular Evaluation of Archival Tumor Tissue in • Locally advanced or metastatic gastric adenocarcinoma at Open to accrual Afu tissue testing Samarasena Subjects with Gastric Cancer time of enrollment: T2-T4b/N0-3b/M0-M1 Smith • 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 Abi-Jaoudeh Nabar Cappauccini Elizabeth Treatment based on Bota Mehir Tharani EAY131: Molecular Analysis for Therapy Choice Positive for specific mutations Open to accrual Myung Afu mutations Ou Turner Nabar Cappuccini Castillo Hsu Elizabeth S1609: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Bota Mehta Mehir Tharani Immunotherapy Recurrent disease - Rare cancer Open to accrual Afu Tumors Myung Ou Pinter-Brown Turner

August 2021 UCI Health Cancer Center — Newport Clinical Trials

Correlative/Non-Treatment Trial PI Newport Sub-I Newport CRCCRC @ Orange Protocol #/Title Mechanism Primary In/Ex Criteria Status Lane Mehta UCI 17-43: Blood Collection Protocol for Circulating Patients must be female, at least 21 years of age or older, Parajuli Nanci Elizabeth Afu Ashley Chanthapadith Tumor Cells and Circulating Cancer Associated Blood Collection with histolocially confirmed breast cancer and be diagnosed Open to accrual Mahdavi Fibroblasts in Breast Cancer Patients as Stage III or IV. Must not have other active cancers. Tsai

Tumor heterogeneity and Coffey-leis cell atlas delineating Breast Cancer patients irrespective of the Hormonal or Her-2 Kessenbrock Elizabeth UCI 17-05: Understanding Intratumoral Heterogeneity BRCA1-driven breast receptor expression status and across Stages I, II, III and IV Parajuli Lane Chang Shim Open to accrual Afu Using Single Cell RNA Sequencing tumor initiation and who are BRCA 1 positive and will undergo breast or axillary Mehta progression in single cell node biopsy, definite surgery or prophylactic surgery (study police resolution group).

UCI 20-101: Prospective Study to Assess the Role of Must have immunotherapy-naïve histologically, Elquza Elizabeth Plasma Exosomal PD-L1 to Predict Response to Immune Senthil Krissy Ghio Blood Collection radiologically, or cytologically confirmed cancer (e.g. Open to accrual Jakowatz Afu Checkpoint Inhibition in Melanoma and Solid Organ melanoma, HCC, colorectal, appendix or gastric cancer) Malignancies

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

S1904: Cluster Randomized Controlled Trial of Patient Standard Educational Patients must have atypical hyperplasia (AH) or lobular Lane and Provider Decision Support to Increase Materials about Breast carcinoma in situ (LCIS) with no history of invasive breast Mahdavi Elizabeth Chemoprevention Informed Choice Among Women Cancer Lin Ashley Chanthapadith carcinoma or ductal carcinoma in situ (DCIS) Open to accrual Mehta Afu with Atypical Hyperplasia or Lobular Carcinoma In Situ- Risk/Chemoprevention + No prior selective estrogen receptor modulators or aromatase Nanci Making Informed Choices on Incorporating Web Based Decision inhibitor usage Chemoprevention into Care (MiCHOICE) Support Tools

Supportive Care/Diagnostic

Newport PI Newport Sub-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 Elizabeth Treatment of Depression and Temozolomide-Induced treatment with temozolomide TMZ -Patient will receive Bota Myung Esterliza Khorram Antidepressant Open to accrual Afu Nausea and Vomiting (CINV) in Newly-Diagnosed High- temozolomide TMZ therapy as part of their standard Grade Glioma Patients on Temozolomide Therapy treatment.

August 2021