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

Conditions

• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Metastatic Sarcoma
• Pancreatic Cancer
• Sarcoma

Eligibility Criteria

Sex

ALL

Age

15 Years - N/A

Healthy Volunteers

Not accepted

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,

Study Details

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).

Key Dates

Start date

Aug 31, 2025

Status verified

Jul 2025

Primary completion

Nov 30, 2025

Completion

Apr 30, 2026

Study Design

Enrollment

26 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Experimental Part 1
  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).
• Experimental: Experimental Part 2
  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).

Primary Outcome Measure

Primary Part 1 Biodistribution of 64Cu-LNTH-1363S [ Time Frame: 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. ]

Central Contacts

• Eryn Bagley
  978-671-8886
  [email protected]

Locations (5)

Find similar trials in Duarte, CA

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