A Study of 177Lu-FAP-2286 in Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

July 30, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2028

Conditions
Solid Tumor
Interventions
DRUG

68Ga-FAP-2286

68Ga-FAP-2286 IV administered as imaging agent for PET scan.

DRUG

177Lu-FAP-2286

"Phase 1:~Patients with positive uptake of 68Ga-FAP- 2286 will receive a fixed dose of 177Lu-FAP-2286 IV administered every 6 weeks for a maximum of 6 doses. Doses range between 3.7 and 9.25 GBq (100-250 mCi).~Phase 2:~Monotherapy: Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D determined in Phase 1 dose escalation in every 4 weeks.~Combination therapy: Patients with positive uptake of 68Ga FAP 2286 will receive 177Lu-FAP-2286 based on dose escalation (starting with dose level 1) followed by dose expansion at selected dose."

Trial Locations (23)

3000

RECRUITING

Novartis Investigative Site, Melbourne

3004

RECRUITING

Novartis Investigative Site, Melbourne

5000

RECRUITING

Novartis Investigative Site, Adelaide

10032

RECRUITING

Columbia University Medical Center, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

15232

RECRUITING

UPMC Hillman Cancer Center, Pittsburgh

27514

RECRUITING

UNC Hospitals, Chapel Hill

32224

RECRUITING

Mayo Clinic, Jacksonville

33136

RECRUITING

University of Miami Hospital and Clinics, Miami

35233

RECRUITING

UAB Comprehensive Cancer Center, Birmingham

48201

RECRUITING

Karmanos Cancer Institute, Detroit

52242

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

55905

RECRUITING

Mayo Clinic, Rochester

60637

RECRUITING

University of Chicago Medical Center, Chicago

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

84112

RECRUITING

Univ of Utah, Huntsman Cancer Institute, Salt Lake City

90095

RECRUITING

University of California Los Angeles (UCLA), Los Angeles

92618

RECRUITING

Hoag Hospital Irvine, Irvine

94158

RECRUITING

UCSF Medical Center, San Francisco

63110-2539

RECRUITING

Saint Louis University Hospital, St Louis

97239-3098

RECRUITING

Oregon Health and Science University, Portland

98109-1023

RECRUITING

Fred Hutchinson Cancer Center, Seattle

H4A 3J1

RECRUITING

Novartis Investigative Site, Montreal

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY