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

LS0386, Clinical and Epidemiological Studies in Lymphoma (CTMS#18-0162)LS0386, Clinical and Epidemiological Studies in Lymphoma (CTMS#18-0162)The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.NCT02736357Adolfo "Enrique" Diaz Duque, MD, MS

S2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreS2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreThis clinical trial aims to validate the results observed in I-SPY2 and will test if adding durvalumab to neoadjuvant chemotherapy can increase pCR rates, shift residual cancer burden to lower values and improve invasive breast cancer free survival in early-stage HRpositive MP2 cancers.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

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.

A First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell MalignanciesA First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell MalignanciesM22-716 is a Phase 1, FIH, open-label, dose escalation, dose expansion, biomarker/pharmacodynamic (PD) study of ABBV-319 in participants with relapsed or refractory (R/R) B-cell malignancies.NCT05512390Daruka Mahadevan, MD, PhD

A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid TumorsA Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid TumorsTo evaluate the safety, tolerability, MTD and the RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available.ClinicalTrials.gov registration not requiredDaruka Mahadevan, MD, PhD

An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors (PROSPER)An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors (PROSPER)This is an open-label, Phase 1/2, dose escalation, dose expansion and cohort expansion study to evaluate the safety, tolerability, PK, PD and clinical activity of FMC-376 in participants with locally advanced unresectable or metastatic solid tumors which harbor KRAS G12C mutation.NCT06244771Daruka Mahadevan, MD, PhD

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

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

A Multi-center, Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of YL205 in Patients with Advanced Solid TumorsA Multi-center, Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of YL205 in Patients with Advanced Solid TumorsThis is a multi-center, open-label, Phase I/II clinical study of YL205. This study includes: Phase I dose escalation and backfill, and Phase II dose expansion. It is to evaluate the safety and tolerability of YL205 in patients with advanced solid tumors who have experienced treatment failure of existing standard therapies, have no standard treatment options, are currently not suitable for standard treatments, or cannot benefit from other approved therapies in dose escalation, and will backfill patients in certain tolerable dose levels to further evaluate the efficacy and safety of YL205.NCT06459973Daruka Mahadevan, MD, PhD