Patient-derived organoid model and circulating tumor cells for treatment response of lung cancer Patient-derived organoid model and circulating tumor cells for treatment response of lung cancer Create a living biobank of PDOs from Stage I-III lung cancer patients.NCT03655015Josephine Taverna, MD

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 Phase 1 Study of IM-1021 In Participants with Advanced MalignanciesA Phase 1 Study of IM-1021 In Participants with Advanced MalignanciesTo evaluate the safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors. To determine the recommended dose(s) and schedule(s) of IM-1021 for further development.ClinicalTrials.gov registration not requiredDaruka Mahadevan, MD, PhD

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

Phase III Randomized Study Testing Non-inferiority of Short-course Ultra-hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) For Stage II-IIIB, Extremity, Resectable Soft Tissue SarcomaPhase III Randomized Study Testing Non-inferiority of Short-course Ultra-hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) For Stage II-IIIB, Extremity, Resectable Soft Tissue SarcomaWe propose a clinical trial comparing standard radiation (RT-25) to ultra-hypofractionated radiation (UHRT-5). If negative, this trial would stop participants from being treated, as many are, with an inferior regimen. If positive, this trial would establish a new standard of careClinicalTrials.gov registration not requiredEva Galvan MD

Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
The first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator's patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.NCT03799523Eva Galvan MD