64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

NCT06298916 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FAPi-1301
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

Conditions

Metastatic Sarcoma; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Colorectal Cancer; Sarcoma

Keywords

FAPi; Imaging; 64Cu-LNTH-1363S

Outcome Measures

Primary Outcomes (3)

• Primary Part 1 Biodistribution of 64Cu-LNTH-1363S

  Time Activity Curves (TACs) describing percentage of the injected activity versus time will be derived for selected organs and tumor lesions and absorbed radiation doses of 64Cu-LNTH-1363S in critical organs (e.g., kidneys, liver) will be estimated.

  During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.

• Primary Part 1 - Optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S

  Optimal dose (radioactivity) and imaging time window will be determined by using image quality scores from blinded central reviews. Each patient will receive 8 ± 1 mCi of 64Cu-LNTH-1363S. The raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with lower injected activities (6 mCi and 4 mCi).

  During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.

• Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression

  Correlation of 64Cu-LNTH-1363S biodistribution with FAP expression by IHC (SUVmean and SUVmax vs IHC score) and compare to circulating FAP in blood as analyzed by ELISA method.

  Post surgery tissue collection to end of study

Secondary Outcomes (4)

• Secondary Parts 1 and 2 Safety and Tolerability

  Part1: From IP administration until the Day 7 (± 1 day) telephone follow up. Part 2: From time of IP administration to until post-surgery IHC sample collection.

• Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma

  From Day 1 until the end of the Scheduled Surgery: IHC sample collection

• Secondary Part 1 and Part 2 Cardiac Safety

  Continuous ECG monitoring at Visit 2

• Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer

  From start of Part 2 to 6 patients enrolled with qualifying imaging

Other Outcomes (2)

• Exploratory Part 1 and Part 2

  From post study intervention administration imaging in each patient (0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours in Part 1 and 2 timepoints in Part 2) to the end of the study].

• Correlation between LRRC15 IHC and FAP expression

  Availability of tumor tissue will be assessed at Screening visit.

Study Arms (2)

Experimental Part 1

EXPERIMENTAL

6 patients will receive 8 ± 1 mCi (\~90 μg mass dose) of the 64Cu-LNTH-1363S on Day 1 in the Intervention Period (raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with 6 mCi and 4 mCi 64Cu injected activities).

Combination Product: 64Cu-LNTH-1363S

Experimental Part 2

EXPERIMENTAL

First 6 evaluable patients will receive the optimal radioactivity determined in Part 1. The remaining 14 evaluable patients will receive either the optimal radioactivity determined in Part 1 (if the sum of the average image quality scores of the first 6 patients is higher or equal to 10.5), or 8 ± 1 mCi (if the sum of the average image quality scores of the first 6 patients is less than 10.5).

Combination Product: 64Cu-LNTH-1363S

Interventions

64Cu-LNTH-1363S COMBINATION_PRODUCT

64Cu-LNTH-1363S, is a highly selective, high affinity FAP inhibitor (FAPi) that is radiolabeled with Copper-64 (64Cu) for PET/CT Imaging,

Experimental Part 1; Experimental Part 2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if all of the following criteria apply:
• Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \<18 years must weigh at least 55 kg.
• Patients with suspected FAP-expressing metastatic sarcoma.
• Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).
• Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.
• Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
• Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
• Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.
• Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \<18 years must weigh at least 55 kg.
• Patients must have histological, pathological, and/or cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.
• Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).
• Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.
• Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
• Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
• Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.

You may not qualify if:

• Patients are excluded from the study if any of the following criteria apply:
• Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.
• Known pregnancy or breastfeeding.
• Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
• Patients participating in another clinical trial at the time of screening for this study.
• Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.
• Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
• History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \> 450 milliseconds) or taking medication known to cause QT/QTc prolongation.
• A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
• Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.
• Evidence of metastatic or advanced, inoperable disease.
• Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.
• Known pregnancy or breastfeeding.
• Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
• Patients participating in another clinical trial at the time of screening for this study.

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

RECRUITING

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

Stanford Hospital & Clinics

Stanford, California, 94305, United States

RECRUITING

BAMF Health, Inc.

Grand Rapids, Michigan, 49503, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Eryn Bagley

CONTACT

978-671-8886; clinicaltrials@lantheus.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Metastatic Sarcoma Part 2: Non-metastatic sarcoma or gastrointestinal tract (GIT) cancer (esophageal, gastric, pancreatic, colorectal cancer)

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-07

Locations

US (5)