Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women (CTMS# 17-0014)Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women (CTMS# 17-0014)The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in women who are at low risk.NCT00539162Georgia McCann MD

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy iA Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy iThe main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.NCT06824467Georgia McCann 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 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

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

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