Cancer clinical trials

More people are living longer thanks to successful cancer treatments resulting from clinical trials. Before new treatments are introduced to patients, they are first studied in the laboratory.

Once preliminary research indicates the possible benefits of a new treatment, clinical trials go through three phases. Phase 1 tests for safety, Phase 2 tests for effectiveness, and Phase 3 tests for both safety and effectiveness in a larger group of patients.

Only after a new treatment passes all three clinical trial phases is it then cleared for general use. All approved cancer treatments available today began as clinical trials.

High-level patient care — Participants receive close monitoring and guidance by clinical trial coordinators and their oncologist.

Access to promising new treatments — Participants may receive a treatment that will be more effective than the standard treatment, and unavailable outside of a clinical trial.

Better treatments — Participants help expand researchers' knowledge and determine whether new treatments will improve outcomes for future patients with cancer.

There may be some costs associated with participating in a trial. Most patients are responsible for copays and deductibles as they would be if they were receiving treatment outside of a clinical trial. The research team will discuss any possible costs with you prior to enrolling.

Ask your doctor if any study at Sharp may be appropriate for you. Your doctor should explain the criteria for trial eligibility, including the stage of cancer being studied; how results will be evaluated; and the potential benefits and risks, such as side effects or other health impacts.

You will receive an informed consent form outlining the purpose of the clinical trial and the risks involved. If there is anything on the form that you do not understand, ask your doctor before signing.

During a clinical trial, you will be monitored and observed closely. If at any time you or your doctor believes the treatment is not in your best interest, you can leave the study.

• A071701, Genomically-guided Treatment Trial in Brain Metastases (NCT03994796), Alliance for Clinical Trials in Oncology

• SHCGBM-003, Evaluation of Claudin-18.2 receptor expression in Glioblastoma Patients. This study is non-interventional. For more information, please contact a Sharp clinical trials specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.

• D8531C00002, CAMBRIA-1: A Phase III, Open-Label, Randomized Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence (NCT05774951), AstraZeneca

• SDX-0103, Amelia-1: This is a Phase 1b/2, open-label, parallel-arms pilot study in post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy, (NCT05455619), SynDevRx, Inc.

• RGX-202-001, A Phase 1 Study of RGX-202-01 (Ompenaclid), a Small Molecule Inhibitor of the Creatine Transporter SLC6a8, as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies With Select Expansion Cohorts, (NCT03597581), Inspirna, Inc.

• CRDF-004/Z0101001, A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation, (NCT06106308), Cardiff Oncology

• MCLA-158-CL01, A Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors, (NCT03526835), Merus N.V.

• D9078C00001, A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9) (NCT05221840), AstraZeneca

• FF10832-PEM-201, A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors, (NCT05318573), Fujifilm Pharmaceuticals

• FALCON, Ethnicity and Lung Cancer Survival: A Test of the Hispanic Sociocultural Hypothesis, University of Arizona. This study is not a clinical trial and is only observational. For more information, please contact a Sharp clinical trials specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.

• BGB-3111-308, MAHOGANY: A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma, (NCT05100862), BeiGene

• S2000, A Randomized Phase 2 Trial Of Encorafenib + Binimetinib + Nivolumab Vs Ipilimumab + Nivolumab In Brafv600-Mutant Melanoma with Brain Metastases (NCT04511013), Southwest Oncology Group

• CA057-001, A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1, (NCT05519085), Bristol Myers Squibb/Celgene

• NRG GU009, Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*), *Prostate RNA Expression/Decipher To Individualize Concurrent Therapy with Radiation, (NCT04513717), NRG Oncology

• NRG GU010, Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score/ Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE), (NCT05050084), NRG Oncology

• A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01), (NCT06120491), AstraZeneca

• FF10832-PEM-201, A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors, (NCT05318573), Fujifilm Pharmaceuticals

• REC-4881-221, A Phase II, Open label study of REC-4881 in participants with unresectable locally advanced or metastatic cancer with AXIN1 or APC mutation, (NCT06005974), Recursion Pharmaceuticals, Inc.

• EAY191, Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial, (NCT05564377), NCI

• DF1001-001, A Phase I/II, first-in-human, multipart, open-label, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of DF1001 in patients with locally advanced or metastatic solid tumors, and expansion in selected indications (NCT04143711), Dragonfly Therapeutics

• MCLA-128-CL01, A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors (eNRGy) (NCT02912949), Merus

• PREDAPT-2, A Multicenter Cancer Biospecimen Collection Study (NCT04510129), Cofactor Genomics, Inc.

• ES2021-05, Specimen Collection Study to Evaluate Biomarkers in Subjects with Cancer, Exact Sciences Corporation. This study is non-interventional. For more information, please contact a Sharp clinical trials specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.