FCS Driving Global Progress in Cancer Care Discoveries

Thirteen Researchers Present Cutting-Edge Studies At 2025 ASCO® Annual Meeting

2025 ASCO® Annual Meeting abstracts featuring FCS research: 516, 2515, 2536 3000, 3009, 3010, 3011, 3030, 3033, 3041, 3042, 3124, 3151, 3517, 3553, 3579, 4006, 5502, 5503, 5523, 5551, 5599, 6024, 8519, 8589, 8598, e23219, e23550, TPS517, TPS1141, TPS3175, TPS5618, TPS8124, TPS8663

Fort Myers, Fla., May 29, 2025 – Findings from 34 clinical research studies conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) are among the groundbreaking scientific advances in cancer care that will be featured as oncology professionals from around the world gather this week at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago.

Thirteen physicians and leaders from the statewide practice will present the outcomes of early and late-phase clinical trials concluded during the past year at three FCS Phase 1 Drug Development Units and FCS clinics throughout Florida.

Research conducted at FCS is made possible through valuable relationships with Sarah Cannon Research Institute, one of the world’s leading clinical research organizations, and Paradigm Health, an AI-enabled clinical trial matching and recruitment platform.

FCS President & Managing Physician Lucio N. Gordan, MD said, “Our robust research program sets us apart from other community oncology practices and is a cornerstone of our mission to deliver convenient access to world-class cancer care.”

“The research findings being presented span new approaches alongside cutting-edge targeted therapies,” said FCS Director of Drug Development Manish R. Patel, MD. “We continue to uncover scientific knowledge that is advancing precision oncology and enhancing outcomes for multiple cancer types, including rare and advanced forms of the disease.”

The following FCS principal investigators are first authors of five abstracts that will be presented throughout the meeting:

• Manish R. Patel, MD
  • First-in-human (FIH) phase 1 study of CUSP06, a cadherin-6 (CDH6)-directed antibody-drug conjugate (ADC), in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors
  • ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update.
• Cesar Augusto Perez, MD, FCS director of drug development, Lake Nona Drug Development Unit
  • First-in-human study of BG-C9074, a B7-H4-targeting ADC in patients with advanced solid tumors: Preliminary results of the dose-escalation phase
• Judy Wang, MD, FCS associate director of drug development, Sarasota Drug Development Unit
  • Efficacy and safety results of a multi-center phase I study of utidelone capsule, a novel oral microtubule inhibitor, in advanced solid tumor patients
  • An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors

The following FCS principal investigators have co-authored 31 additional abstracts and publications of research results and other clinical findings featured throughout the annual meeting:

• Barry Berman, MD, MS
  • E7386 study 102: Global dose-expansion cohort of E7386 + lenvatinib (LEN) in patients (pts) with advanced endometrial cancer (aEC) that progressed on platinum-based chemotherapy (chemo) and an anti-PD-(L)1 immunotherapy (IO).
• Lowell Hart, MD, FACP
  • Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age
• Lucio N. Gordan, MD; Josh Eaves, FCS chief development & strategy officer; Kiana Mehring, FCS senior director, strategic partnerships – managed care
  • National Comprehensive Cancer Network guideline compliance in an oncology value-based care program serving Medicare members.
• Maen Hussein, MD, FCS medical director, value-based care
  • LODESTAR: A single-arm phase II study of rucaparib in solid tumors with pathogenic germline or somatic variants in homologous recombination repair genes
  • Depth of response and progression-free survival in patients with advanced ALK-positive non–small-cell lung cancer treated with lorlatinib.
  • TIGOS-LS, an open-label, randomized study of BMS-986489 vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer.
• Bradley Monk, MD, FCS medical director of late-phase clinical research
  • Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses

* Also published in the Annals of Oncology

• Patient-reported outcomes (PROs) in locally advanced cervical cancer (LACC): Insights from the OUTBACK trial.
• miRNA(s) expression as predictive biomarkers in recurrent/metastatic cervical cancer: The NRG Oncology/GOG-0240 NIH Cancer Moonshot.
• Impact of disease progression on health-related quality of life (HRQOL): Updated results from the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line (1L) maintenance therapy in patients with newly diagnosed advanced ovarian cancer (aOC).
• TroFuse-020/GOG-3101/ENGOT-cx20: A phase 3, randomized, active-controlled, open-label, multicenter study comparing sacituzumab tirumotecan monotherapy vs treatment of physician’s choice as second-line treatment for recurrent or metastatic cervical cancer.
• Ultrasensitive detection and tracking of circulating tumor DNA to predict relapse and survival in patients with locally advanced cervical cancer: phase III CALLA trial analyses
• Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3, randomised, controlled, open-label trial (Published in The Lancet)

• Manish R. Patel, MD
  • Safety and efficacy of ADG126 (an anti-CTLA-4 masking antibody) in combination with pembrolizumab: Updated results of phase 1b/2 study in advanced MSS CRC
• Ivor Percent, MD
  • Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)
• Cesar Augusto Perez, MD
  • DB-1310, a HER3-targeted ADC, in pts with advanced solid tumors: Preliminary results from the phase 1/2a trial.
  • Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001).
  • BMS-986504 in patients (pts) with advanced solid tumors with homozygous MTAP deletion (MTAP-del): Clinical update and first report of pharmacokinetics (PK) and pharmacodynamic (PD) analyses from CA240-0007.
  • Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial.
  • Phase 1 study of zavondemstat (TACH101), a first-in-class KDM4 inhibitor, in patients with advanced solid tumors: Results on safety, pharmacokinetics, and anti-tumor activity.
  • Vilastobart (XTX101), a tumor-activated, Fc-enhanced anti–CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with MSS CRC
  • Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
• Alexander Philipovskiy, MD, PhD
  • Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients
  • Preclinical and phase 1/2 data of the CHK1 inhibitor BBI-355 in development for esophageal and gastric cancers (EGC) with EGFR or FGFR2 amplifications
  • A phase 1/2 open-label, multicenter, first-in-human study of the safety, tolerability, pharmacokinetics, and antitumor activity of BH-30643 in adult subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations (SOLARA).
• Judy Wang, MD
  • Initial phase 1 dose escalation data for emiltatug ledadotin (Emi-Le), a novel B7-H4-directed dolasynthen antibody-drug conjugate
  • Final results of a phase 1 study of EP0031, a next generation selective RET inhibitor (SRI) in patients with SRI naïve or pretreated advanced RET-altered tumors.
  • Emiltatug ledadotin (Emi-Le): A B7-H4-directed dolasynthen antibody-drug conjugate (ADC) being investigated in phase 1 dose expansion in patients with triple negative breast cancer who received at least one prior topoisomarase-1 inhibitor ADC.
  • A phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of the first-in-class cyclin A/B RxL inhibitor CID-078, an orally bioavailable, cell-permeable macrocycle
  • Artificial intelligence (XGBoost) in predicting outcomes among CAR-T therapy patients: The impact of malnutrition and comorbidities using the National Inpatient Sample (2020-2022).
• Faye Yin, MD
  • Artificial intelligence (XGBoost) in predicting outcomes among CAR-T therapy patients: The impact of malnutrition and comorbidities using the National Inpatient Sample (2020-2022).
  • Survival of malignant peripheral nerve sheath tumor of the trachea, mediastinum, and other respiratory organs: Analysis of SEER database

“Our pioneering research and late-phase trials are transforming clinical practice,” said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. “Every discovery sharpens our ability to deliver more precise, effective treatments.”

FCS Chief Executive Officer Nathan H. Walcker said, “The ASCO® annual meeting showcases the top research of the year from around the globe and FCS is proud to again be recognized at the forefront of shaping the future of cancer care.”

All abstracts and presentations are available to view at ASCO® 2025 Annual Meeting.

The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care.