Actively Recruiting
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
Led by Novartis Pharmaceuticals · Updated on 2026-04-23
222
Participants Needed
40
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves. Given the restricted expression profile, FAP is a promising target for peptide-targeted radionuclide imaging and therapeutic agents. Phase 1 of this study is designed to evaluate the safety and establish the recommended intravenous (IV) Phase 2 dose (RP2D) for \[177Lu\]Lu FAP 2286 monotherapy in participants with FAP expressing solid tumors. Phase 2 is designed to evaluate the safety and efficacy of \[177Lu\]Lu FAP 2286 as monotherapy in participants with pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and breast cancer (BC) and in combination with chemotherapy in participants with untreated PDAC or relapsed NSCLC. Participants in both Phase 1 and 2 will be selected for treatment with \[177Lu\]Lu FAP 2286 based on \[68Ga\]Ga FAP 2286 imaging for determining tumor FAP expression.
CONDITIONS
Official Title
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- At least 18 years old when consent is signed
- Agreed to provide fresh or archival tumor tissue if available
- Adequate bone marrow function (ANC 65 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin 65 9 g/dL)
- Adequate liver function (AST and ALT 64 3x upper normal limit or 64 5x if liver metastases; bilirubin 64 1.5x upper normal limit or 64 3x if Gilbert's syndrome; albumin 65 30 g/L; INR 64 1.5x normal; aPTT 64 1.5x normal)
- Adequate kidney function (eGFR 65 60 mL/min)
- ECOG performance status 0 or 1
- Life expectancy of at least 6 months
- Measurable disease by RECIST v1.1 with at least one lesion meeting size criteria
- For Phase 1: advanced/metastatic solid tumor refractory to prior treatments with no satisfactory options
- For Phase 2: specific confirmed pancreatic, lung, or breast cancer types with defined prior treatment and progression criteria
You will not qualify if you...
- Active cancers other than the one being studied unless successfully treated or low-risk tumors
- Symptomatic or untreated brain metastases or leptomeningeal disease
- Recent anticancer treatment within 14 days (28 days for checkpoint inhibitors)
- Prior radiopharmaceutical therapy or extensive radiation to bone marrow or kidney
- Ongoing treatment side effects except alopecia or vitiligo
- Significant uncontrolled heart disease or abnormal heart rhythms
- Severe urinary problems that prevent following radiation safety
- Untreated or active severe HIV infection (controlled HIV allowed)
- Recent surgery unless fully recovered
- Pregnant or breastfeeding women or unwillingness to use effective contraception
- Significant recent weight loss (>10% body weight in 28 days)
- Conditions increasing risk or interfering with study participation
- Inability to complete required imaging
- Known allergy to study drugs
- Severe active infections requiring treatment within 2 weeks
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Trial Site Locations
Total: 40 locations
1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
Hoag Hospital Irvine
Irvine, California, United States, 92618
Actively Recruiting
4
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
5
UCSF Medical Center
San Francisco, California, United States, 94158
Actively Recruiting
6
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Actively Recruiting
8
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
9
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Saint Louis University Hospital
St Louis, Missouri, United States, 63110-2539
Actively Recruiting
13
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
14
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
15
UNC Hospitals
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
16
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Actively Recruiting
17
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
18
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
Univ of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
20
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109-1023
Actively Recruiting
21
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
22
Novartis Investigative Site
Melbourne, Victoria, Australia, 3000
Actively Recruiting
23
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
24
Novartis Investigator Site
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
25
Novartis Investigating Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
26
London Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
27
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
28
Novartis Investigator Site
Montpellier, Cedex 5, France, 34298
Actively Recruiting
29
Novartis Investigator Site
Bordeaux, France, 33000
Actively Recruiting
30
Novartis Investigator Site
Clermont-Ferrand, France, 63011
Actively Recruiting
31
Novartis Investigating Site
Marseille, France, 13385
Actively Recruiting
32
Novartis Investigator Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
33
Novartis Investigative Site
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
34
Novartis Investigating Site
Milan, Italy, 20141
Actively Recruiting
35
Novartis Investigator Site
Naples, Italy, 80131
Actively Recruiting
36
Novartis Investigative Site
A Coruña, Spain, 15006
Actively Recruiting
37
Novartis Investigating Site
Badalona, Spain, 08916
Actively Recruiting
38
Novartis Investigating Site
Madrid, Spain, 28040
Actively Recruiting
39
Novartis Investigating Site
Madrid, Spain, 28041
Actively Recruiting
40
Novartis Investigating Site
Madrid, Spain, 28050
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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