Phase 1 Clinical Trial of Avasopasem in Patients with Metastatic Hormone Receptor Positive Breast Cancer with Progression on a CDK 4/6 Inhibitor and Hormonal TherapyPhase 1 Clinical Trial of Avasopasem in Patients with Metastatic Hormone Receptor Positive Breast Cancer with Progression on a CDK 4/6 Inhibitor and Hormonal TherapyThis is a single institution, non-randomized, phase 1 with a dose expansion clinical trial investigating the addition of a novel agent, Avasopasem (GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger).ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoA Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoThis is a Phase 3 open-label, active-control, 2:1 randomized study with parallel assignment of PDS0101 plus pembrolizumab (referred to as ‘the investigational arm’) vs pembrolizumab alone (referred to as ‘the control arm’) in immune checkpoint inhibitor (ICI) naïve subjects with first line unresectable recurrent and/or metastatic (R/M) HPV16-positive HNSCC with a CPS ≥ 1.NCT06790966Devi Meyyappan MD

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast CancerVIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast CancerThis is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.NCT06757634Virginia Kaklamani, MD, DSc

Phase II Trial of Zanzalintinib (XL-092) in Combination with Durvalumab plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)Phase II Trial of Zanzalintinib (XL-092) in Combination with Durvalumab plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)Phase II trial evaluating the combination of XL-092 with durvalumab and tremelimumab in unresectable HCC. This phase II trial design will be preceded by a safety lead in of 9-12 patients.NCT06698250Sukeshi Patel Arora, MD

A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid TumorsA Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid TumorsPart 1 (dose escalation): to evaluate the safety and tolerability of SIM0505 and determine the maximum tolerated dose (MTD)NCT06792552Daruka Mahadevan, MD, PhD

NRG-GI011, A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100) NRG-GI011, A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100) NRG-GI011 (LAP100) is a Phase III randomized trial assessing the addition of dose-escalated radiotherapy to chemotherapy in LAPC.NCT06958328

A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients with Advanced or Metastatic Solid Tumors A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients with Advanced or Metastatic Solid Tumors This is a phase Ia/Ib, open-label, dose-escalation and dose-expansion study designed to evaluate BSI-082 monotherapy and combined therapy with Trastuzumab deruxtecan (T-DXd) in patients with locally advanced or metastatic solid tumors.ClinicalTrials.gov registration not requiredJohn Sarantopoulos MD

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid TumorsA Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid TumorsDose-Escalation Part (Part 1)Primary Objectives:•To assess the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the maximum tolerated dose (MTD) of YL217 in patients with advanced solid tumorsBackfill Part (Part 2)Primary Objectives:•To further evaluate the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the recommended dose(s) for expansion (RDE(s)) of YL217 in patients with advanced solid tumorsDose-Expansion Part (Part 3)Primary Objectives:•To further evaluate the efficacy of YL217 at the RDE(s) in patients with the selected advanced solid tumors such as colorectal adenocarcinoma, gastric, esophageal or gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma•To determine the recommended phase 2 dose (RP2D) of YL217NCT06859762Sukeshi Patel Arora, MD

MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684 is being developed for treatment of solid tumors. This basket study of MK-5684 isdesigned to assess the safety, tolerability, and preliminary efficacy of MK-5684 in selectedadvanced solid tumor indications.ClinicalTrials.gov registration not requiredSaba Shaikh, MD