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

UCI 14-67: A Phase II Study of Breast Cancer Treatment Using Mahdavi No prior treatment with , , , , Jacqueline Ashley Weekly Carboplatin + Paclitaxel with + HER-2 monoclonal antibody Mehta Nabar deruxtecan (DS-8201a), or any other investigational Open to accrual Nguyen Chanthapadith Trastuzumab (HER2+) or (HER2-) in the VEGF monoclonal antibody Nanci anti-HER2, anti-EGFR, or HER2 TKI agent or T-DM1. Neoadjuvant Setting 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 Patients must have triple-negative breast cancer and not be Mahdavi and Safety of MK-3475 as Adjuvant Therapy for Triple planning to recieve adjuvant anti-HER2 or endocrine therapies after Nabar Jacqueline Ashley Anti-PD-1 humanized Mehta Receptor-Negative Breast Cancer with > 1 cm Residual completion of neoadjuvant Open to accrual Nanci Nguyen Chanthapadith monoclonal antibody Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Residual disease must be ≥ 1 cm in greatest dimension, and/or have Coluzzi Neoadjuvant Chemotherapy positive lymph nodes (ypN+) observed on pathologic exam

A011801: The COMPASSHER2 Trials (Comprehensive Use of Mahdavi Pathologic Response Assessment to Optimize Therapy in Patients must have HER2+ breast cancer with residual disease after Nabar Ashley anti-PD-1 inhibitor Parajuli TBD HER2-Positive Breast Cancer): COMPASSHER2 Residual NACT Open to accrual Nanci Chanthapadith (immunotherapy) Disease (RD), A Double-Blinded, Phase III Randomized Trial of No prior treatment with TDM-1 Coluzzi 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 Mahdavi with Fulvestrant in Patients with ER/PR + HER-2 Ashley CKD Inhibitor + Neoadjuvant •Patients must have localized recurrence while on adjuvant Parajuli Nabar TBD Negative Breast Cancer who Developed Localized Recurrence Open to accrual Chanthapadith Endocrine Therapy endocrine therapy Nanci While on Adjuvant Endocrine Therapy with Molecular •Patients must not have inflammatory breast cancer Coluzzi 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 J Baclig 509-2759 June 2021 1 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- Mahdavi Tucatinib or Placebo in Combination with Ado- mediated inhibition using Patients must have history of prior treatment with a taxane and Ashley Parajuli Nabar TBD (T-DM1) for Subjects with inhibitor trastuzumab in any setting, separately or in combination. Prior Open to Accrual Chanthapadith Nanci Unresectable Locally-Advanced or Metastatic HER2+ and antibody-based pertuzumab therapy is allowed, but not required. Coluzzi 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 Ashley of Paclitaxel/Trastuzumab/Pertuzumab with PD-L1 antibody + HER2 including: de novo metastatic diseas without prior history of Parajuli Nabar TBD Open to accrual Chanthapadith 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 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 •For patients enrolling on Phase E portion of the study: Mahdavi Fulvestrant and Abemaciclib in Combination with -Must have resistance to endocrine therapy in metastatic Ashley Temporarily Closed Parajuli Nabar TBD Copanlisib (FAC) versus Fulvestrant and Abemaciclib Pan-class I PI3K inhibitor setting Chanthapadith to Accrual Nanci Alone (FA) for Endocrine-Resistant, Hormone Receptor -No prior treatment w/ CDK 4/6 inhibitor, Fulvestrant, or PI3K Coluzzi Positive, HER2 Negative Metastatic Breast Cancer inhibitor in metastatic setting -No brain metastasis

Triple Negative Breast Cancer

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

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 J Baclig 509-2759 June 2021 2 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 ctDNA as prognostic Zell Dayyani TBD Kristian Ghio as a Predictive Biomarker in Adjuvant Chemotherapy in • Appropriate for active surveillance (i.e., no adjuvant Suspended biomarker Lee Patients with Stage IIA Colon Cancer (COBRA) chemotherapy) at the discretion of the evaluating oncologist based on current practice patterns

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

Prior history of rectosigmoid colon or rectal cancer with post- Telephone Diet Zell S1820: A Randomized Phase II Trial of the Altering Intake, surgical permanent ostomy or anastomosis. Last date of Modification Coaching Carmichael Dayyani TBD Ana Vargas Managing Symptoms (AIMS-RC) Intervention for Bowel treatment for rectal cancer (surgery, chemo, RT) must be at Open to accrual (AIMS-RC) vs Telephone Lee 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 Combined •2nd or 3rd line treatment Zell Cabozantinib and Dayyani TBD Kristian Ghio with Pembrolizumab in Metastatic Gastric and •Progression after at least one line of platinum FU-containing Open to accrual Lee Pembrolizumab Gastroesophageal Adenocarcinoma regimen

• Undergone surgery for stage II or III colorectal cancer with Zell UCI 20-03: BESPOKE Study of ctDNA Guided Therapy in ctDNA-guided therapy available tissue and whole blood samples Dayyani TBD Baoan Huynh Open to accrual Lee Colorectal Cancer (CRC) 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 UCI 20-63: A Phase IIa, Multicenter, Open-Label Study of received no prior systemic treatment in the locally DKN-01 in Combination with Tislelizumab ± advanced/metastatic setting (first-line treatment); exclusion: HER2- positive Zell Chemotherapy as First-Line or Second-Line Therapy in DKN-01 + tislelizumab + Dayyani TBD Kristian Ghio • Part B will enroll patients who received only 1 prior systemic Open to accrual Lee Adult Patients with Inoperable, Locally Advanced or CAPOX 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)

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 J Baclig 509-2759 June 2021 3 UCI Health Cancer Center — Newport Clinical Trials

GI

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

UCI 19-36: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of •HCC with completed curative therapy (resection or ablation) Durvalumab: PD-L1 Monotherapy or in Combination With Bevacizumab as •Patients must be randomized within 12 weeks of completing Dayyani Lee TBD Kristian Ghio inhibitor; Bevacizumab: Open to accrual Adjuvant Therapy in Patients With Hepatocellular curative therapy VEGF inhibitor Carcinoma Who Are at High Risk of Recurrence After •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 •1st line treament TACE + Durvalumab: PD-L1 •Imaging confirmed HCC Chemoembolization (TACE) in Combination with either Dayyani Lee TBD Kristian Ghio inhibitor + Bevacizumab: • Child-Pugh A-B7 Open to accrual Durvalumab Monotherapy or Durvalumab plus VEGF inhibitor •Vp1 and Vp2 portal vein thrombus allowed Bevacizumab Therapy in Patients with Locoregional •Up to 4 TACE treatments allowed in 16-week period Hepatocellular Carcinoma (EMERALD-1)

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

•1st line systemic treatment UCI 20-79: A Phase Ib/II, Open-Label, Multicenter, •Histology/Cytology confirmed locally advance or metastatic Randomized Umbrella Study Evaluating the Efficacy and Stage 1: Atezo/bev vs and/or unresectable HCC Zell Dayyani TBD Cindy Duong Safety of Multiple Immunotherapy-Based Treatment atezo/bev + tiragolumab vs •Child Pugh A Open to accrual Lee Combinations in Patients with Advanced Liver Cancers atezo/bev + tocilizumab •Prior local therapy allowed(required:untreated measurable (Morpheus Liver) 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 Tivozanib •Child Pugh A Lee Lee TBD Kristian Ghio in Combination with Durvalumab in Subjects with Tivozanib, durvalumab Open to accrual • Previous locoregional treatment: wash-out of 28 days prior to Untreated Advanced Hepatocellular Carcinoma enrollment

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 J Baclig 509-2759 June 2021 4 UCI Health Cancer Center — Newport Clinical Trials

GI

• Gastric: HER2-, chemotherapy-naïve • CRC (colorectal): microsatellite-stable, received up to 3 prior UCI 19-119: Phase 1/1b Study to Evaluate the Safety and systemic chemotherapy regimens Cindy Duong 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 Nabar TBD Open to accrual Jasmine Balangue Budigalimab and/or Chemotherapy in Subjects with PD-1 and/or mFOLFOX6 therapies Zell 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 Oxaliplatin, 5-Fluorouracil/Leucovorin versus Nab- Dayyani Dayyani TBD Jasmine Balangue oxaliplatin + 5-FU vs Gem + •Initial diagnosis of metatastic disease must have occurred Open to accrual Paclitaxel Plus Gemcitabine in Subjects Who Have Not Abraxane within < 6 from screening. Previously Received 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 3 months from surgical diagnosis. Bota Bota TBD Mehir Tharani In Bevacizumab-Naive Subjects With Recurrent WHO TTF device Open to accrual Histological evidence of WHO grade III anaplastic glioma or Grade III Malignant Astrocytoma WHO grade II low grade glioma w

Heme Trials

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

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 J Baclig 509-2759 June 2021 5 UCI Health Cancer Center — Newport Clinical Trials

Correlative Trials

• Archival tumor tissue sample for central lab for MUC17 and UCI 19-55: A Non-Interventional Biomarker Study on the CLDN18.2 testing Dayyani MUC17 and CLDN18.2 Dayanni TBD Jasmine Balangue Molecular Evaluation of Archival Tumor Tissue in • Locally advanced or metastatic gastric adenocarcinoma at Open to accrual Zell tissue testing Subjects with Gastric Cancer 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 Treatment based on Bota Bota TBD Mehir Tharani EAY131: Molecular Analysis for Therapy Choice Positive for specific mutations Open to accrual mutations Bota S1609: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Bota TBD Mehir Tharani Immunotherapy Recurrent disease - Rare cancer Open to accrual Pinter-Brown Tumors

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 J Baclig 509-2759 June 2021 6 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 Patients must be female, at least 21 years of age or older, with Nabar Parajuli TBD Ashley Chanthapadith Tumor Cells and Circulating Cancer Associated Blood Collection histolocially confirmed breast cancer and be diagnosed as Open to accrual Nanci Fibroblasts in Breast Cancer Patients Stage III or IV. Must not have other active cancers. Mahdavi

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

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

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

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 Treatment of Depression and Temozolomide-Induced treatment with temozolomide TMZ -Patient will receive Bota Bota TBD Joanne Baclig Antidepressant Open to accrual Nausea and Vomiting (CINV) in Newly-Diagnosed High- temozolomide TMZ therapy as part of their standard Grade Glioma Patients on Temozolomide Therapy treatment.

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 J Baclig 509-2759 June 2021 7