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Recruiting NCT07213791

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

Phase I Interventional Ovarian Neoplasms Breast Neoplasms Pancreatic Intraductal Neoplasms Colorectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4337713.
Who it may be relevant to
Registry conditions: Ovarian Neoplasms, Breast Neoplasms, Pancreatic Intraductal Neoplasms, Colorectal Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, Germany, Japan, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

Overview

This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.

Interventions

  • Drug LY4337713
    Administered IV.

Primary outcome measures

  • Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities [Time frame: Cycle 1 (28 days)]
  • Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) [Time frame: Baseline through imaging follow-up, up to 5 years]
Secondary outcome measures (8)
  • Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs [Time frame: Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)]
  • Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713 [Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)]
  • Phase 1a: PK: Area Under the Concentration Time Curve (AUC) of LY4337713 [Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)]
  • Phase 1a: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) [Time frame: Baseline through imaging follow-up, up to 1 year]
  • Phase 1a: Number of Participants with Best Overall Response (BOR) [Time frame: Baseline through imaging follow-up, up to 1 year]
  • Phase 1a and 1b: Duration of Response (DOR) [Time frame: Baseline through imaging follow-up, up to 5 years]
  • Phase 1a and 1b: Time to Response (TTR) [Time frame: Baseline through imaging follow-up, up to 1 year]
  • Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR) [Time frame: Baseline through imaging follow-up, up to 1 year]

Eligibility criteria

Inclusion criteria

  • Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
  • Must have histologically or cytologically confirmed diagnosis of one of the following:
  • Adenocarcinoma of the pancreas
  • Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer
  • HER2-positive breast cancer
  • Triple negative breast cancer (TNBC)
  • Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)
  • Other solid tumors
  • Gastric cancer (adenocarcinoma)
  • Colorectal cancer (CRC)
  • Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
  • Cholangiocarcinoma
  • Must have received prior treatments as indicated below:
  • Phase 1a
  • Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.
  • HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4/6 inhibitor.
  • HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).
  • TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.
  • Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.
  • Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
  • Phase 1b:
  • Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.
  • Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
  • Measured creatinine clearance ≥60 milliliters per minute (mL/min)

Exclusion criteria

  • Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
  • Have significant cardiovascular disease
  • Have prolongation of the corrected QTcF >470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)
  • Have evidence of ongoing and untreated urinary tract obstruction
  • Had previous hemi- or total-body radiation.
  • Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \[CAR-T therapy, T-cell receptor \[TCR\] therapy, etc.)
  • Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 20 centers
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Stanford University Medical Center — Stanford
  • Biogenix Molecular, LLC — Miami
  • Moffitt — Tampa
  • Indiana University (IU) School of Medicine — Indianapolis
  • United Theranostics — Glen Burnie
  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • … and 12 more centers
Netherlands · 6 centers
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL) — Amsterdam
  • Amsterdam UMC - Locatie VUmc — Amsterdam
  • Erasmus MC — GE Rotterdam
  • Maastricht University Medical Center — Maastricht
  • Stichting Radboud Universitair Medisch Centrum — Nijmegen
  • Universitair Medisch Centrum Utrecht — Utrecht
Japan · 2 centers
  • National Cancer Center Hospital East — Chiba
  • Kyoto University Hospital — Kyoto
China · 1 center
  • Fudan University Zhongshan Hospital — Shanghai
Germany · 1 center
  • Universitaetsklinikum Essen — Essen

Identifiers

NCT: NCT07213791 · 27513 · J6K-OX-JSFA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗