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FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)

NCT05432193•POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult (\>18 years) male and female patients
•2. Females of childbearing potential and males and their female partner(s) of childbearing potential must use two acceptable forms of contraception, one being a barrier method, during the study and also for 31 weeks (females) or 18 weeks (males) after last study drug administration.
•3. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
•4. The patient has read, understood, and signed the written informed consent form(s)
•5. Advanced or metastatic solid tumor that is refractory to standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy:
•* Adenocarcinoma of the Pancreas
•* High grade Soft Tissue Sarcoma (excluding Chordoma)
•* Esophageal Cancer (Squamous Cell Carcinoma or Adenocarcinoma, excluding Gastroesophageal Junction Cancer at US sites only)
•* Colorectal Cancer
•* Melanoma Skin Cancer
+18 more criteria

Exclusion Criteria

•1. Patient has metastatic brain disease
•2. Women who are pregnant, lactating, or planning to attempt to become pregnant during the study or within 31 weeks after last administration of study drug
•3. Males with female partners who are pregnant, lactating or planning to attempt to become pregnant during this study or within 18 weeks after last administration of study drug
•4. Subject has received prior hemi- or total- body radiation
•5. Subject has received whole brain radiation
•6. History of any grade 4 myelosuppression, or grade 3 myelosuppression requiring more than 6 weeks recovery
•7. History of any kidney dysfunction (e.g., acute kidney failure, acute tubular necrosis (ATN)) for any reason (only in US)
•8. Secondary malignancy that may interfere with the safety assessments of this study
•9. Patient has any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while on the study or that could confound discrimination between disease- and study treatment-related toxicities
•a. Or the patient has persistent NCI-CTCAE version 5.0 Grade ≥ 2 toxicity due to prior cancer therapy. Permitted exceptions include Grade 2 neuropathy, alopecia, endocrinopathy with replacement therapy, and anemia (only in US)
+9 more criteria

Locations (4)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Key Dates

Start Date

July 13, 2022

Primary Completion Date

November 10, 2023

Completion Date

October 2, 2024

Last Updated

June 25, 2025

Enrollment

ACTUAL participants

Conditions

Pancreatic Ductal AdenocarcinomaColorectal CancerEsophageal CancerMelanoma (Skin)Soft Tissue SarcomaHead and Neck Squamous Cell CarcinomaCholangiocarcinoma

Interventions

[Ga-68]-PNT6555

DRUG

[Lu-177]-PNT6555

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors