Status:

RECRUITING

A First-in-Human Study of FID-022 in Solid Tumor Patients

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborating Sponsors:

Florida Cancer Innovation Fund

Conditions:

Pancreatic Cancer

Cancer Cachexia

Eligibility:

All Genders

18+ years

Brief Summary

This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibi...

Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy (e.g.pancreatic ductal adenocarcinoma, acinar cell carcinoma, pancreatic adenosquamous carcinoma, etc.) or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during the screening or early study period.
  • Presentation consistent with resectable, borderline resectable, local, or locally advanced, or metastatic disease
  • May or may not have had surgery
  • Treatment plan likely includes systemic therapy for pancreatic cancer
  • ECOG performance status 0-2
  • Able to tolerate oral intake and not currently receiving enteral or parenteral nutrition
  • Able to read and speak English
  • Able to provide written informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding at the time of enrollment
  • Current use of tube feeding (enteral) or total parenteral nutrition
  • Presence of ascites or other findings suggestive of decompensated disease
  • Evidence or history of bowel obstruction or any gastrointestinal condition that may limit food intake
  • Severe or uncontrolled psychiatric illness (e.g., psychosis, dementia) that would interfere with participation
  • Presence of other uncontrolled intercurrent illnesses (e.g., infection, heart failure, liver failure) that may interfere with protocol adherence

Key Trial Info

Start Date :

October 8 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT07249775

Start Date

October 8 2025

End Date

October 1 2026

Last Update

January 28 2026

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612