Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)This is a Phase 3, global, multicenter, randomized, open-label study.ClinicalTrials.gov registration not requiredVirginia Kaklamani, MD, DSc

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY FOR LNCB74, A B7-H4 TARGETED ANTIBODY DRUG CONJUGATE, AS MONOTHERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORSA PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY FOR LNCB74, A B7-H4 TARGETED ANTIBODY DRUG CONJUGATE, AS MONOTHERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORSThe first-in-human clinical study will be a Phase 1, multicenter, open-label, multiple dose, two-part study of LNCB74 that will include Dose Escalation (Part 1) and Dose Expansion/Optimization (Part 2). The objectives of this study will be to determine the safety and tolerability, define the maximum tolerated dose (MTD), maximal administered dose (MAD) and/or the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of LNCB74 in participants with advanced or metastatic solid tumors.ClinicalTrials.gov registration not requiredDaruka Mahadevan, MD, PhD

Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-Cell Lymphoma (DLBCL) Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-Cell Lymphoma (DLBCL) This study is an investigator-initiated, phase I, single arm, open label clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome, defined as an NCCN-IPI score of 2 or higher.NCT06977711Adolfo "Enrique" Diaz Duque, MD, MS

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that START-001 is a two-part, open label, FIH Phase 1/2 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of STAR0602 as a monotherapy in subjects with advanced solid tumors. ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI 4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI 4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)This is a single-arm, phase II study of patients with advanced HCC with Child-Pugh B cirrhosis who are eligible for first-line treatment with T300+D.ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

Phase 2 clinical trial entitled A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) Phase 2 clinical trial entitled A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of radiation therapy (RT) and concurrent temozolomide (TMZ) chemotherapy for patients with newly diagnosed glioblastoma (GB).NCT04752813Andrew Brenner, MD, PhD

A Phase 1a/1b Study of the PI3a:RSS Breaker BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial) A Phase 1a/1b Study of the PI3a:RSS Breaker BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial) First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with trastuzumab in patients with advanced solid tumors.ClinicalTrials.gov registration not requiredVirginia Kaklamani, MD, DSc

Metabolic kinetic phenotyping to predict cachexia and health outcomes in response to chemoradiation in patients with Head & Neck CancerMetabolic kinetic phenotyping to predict cachexia and health outcomes in response to chemoradiation in patients with Head & Neck CancerFifteen patients with advanced H&N cancer who will receive chemoradiation therapy as first line treatment will be studied (as weight loss is expected). The cancer patients will be recruited at the UT Health Mays Cancer Center (MCC) in San Antonio with testing to be performed at the Barshop Institute. The cancer group will be compared to 15 control subjects, recruited at CTRAL (Center for Translational Research on Aging and Longevity) in College Station, who are age/sex/BMI matched and with no active or historic cancer diagnosis based on extensive medical screening.ClinicalTrials.gov registration not requiredSherri Cervantez, MD

NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED SRS (FSRS) FOR INTACT BRAIN METASTASES NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED SRS (FSRS) FOR INTACT BRAIN METASTASES NRG-BN013 is an unblinded, randomized phase III trial to determine if the time to local failure is significantlylonger with FSRS compared to SRS in patients with intact brain metastasis.NCT06500455Eva Galvan MD

A Multicenter Phase 1 Study to Determine the Safety and Efficacy of Multiple Doses at Defined Intervals of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Administered via Intraventricular Catheter for Any Primary Solid Tumor Cancer with LepA Multicenter Phase 1 Study to Determine the Safety and Efficacy of Multiple Doses at Defined Intervals of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Administered via Intraventricular Catheter for Any Primary Solid Tumor Cancer with LepThis is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD/MFD for a given dose, interval duration, and number of doses.ClinicalTrials.gov registration not requiredAndrew Brenner, MD, PhD