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.

• 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.

• 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.

• DS3201-324, A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors, (NCT06244485), Daiichi Sankyo

• A012301: LoTam, A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer, (NCT06671912), Alliance for Clinical Trials in 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.

• DB1303-O-1001, A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors, (NCT05150691), DualityBio, Inc.

• EIK1003-001, A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors, (NCT06253130), Eikon Therapeutics

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc

• DS3201-324, A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors, (NCT06244485), Daiichi Sankyo

• Beamion BCGC-1, A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread, (NCT06324357), Boehringer Ingelheim

• DS3201-324, A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors, (NCT06244485), Daiichi Sankyo

• D702FC00001, A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03), (NCT06627647), AstraZeneca

• Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment, (NCT06151574), Boehringer Ingelheim

• TROPION-Lung14, A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer, (NCT06350097), AstraZeneca

• TROPION-Lung12, A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features, (NCT06564844), AstraZeneca

• PREDAPT-2, A Multicenter Cancer Biospecimen Collection Study (NCT04510129), Cofactor Genomics, Inc. This study is non-interventional. For more information, please contact a Sharp Clinical Trials Specialist at (858) 939-4030 or ClinicalOncologyResearch@sharp.com.

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc

• 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

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc

• 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

• EvoPAR-Prostate02, A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy, (NCT06952803), AstraZeneca

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

• Beamion BCGC-1, A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread, (NCT06324357), Boehringer Ingelheim

• EIK1003-001, A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors, (NCT06253130), Eikon Therapeutics

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc

• PREDAPT-2, A Multicenter Cancer Biospecimen Collection Study (NCT04510129), Cofactor Genomics, Inc. This study is non-interventional. For more information, please contact a Sharp clinical trials specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.

• 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.