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Radiopharmaceutical

FAPi Radioligand Therapy for Solid Cancers (FRONTIER Trial)

Phase 1

Waitlist Available

Research Sponsored by POINT Biopharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, hypopharynx, nasopharynx, and larynx) (only at Canadian sites), Cholangiocarcinoma (only at Canadian sites)

Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug until disease progression (up to approximately 3 years)

Awards & highlights

FRONTIER Trial Summary

This trial will study two different treatments in people with solid tumors that have too much of a protein called FAP. The goal is to find out if they are safe and what the best dose is.

Who is the study for?

Adults with advanced solid tumors (like pancreatic, colorectal, or skin cancer) that resist standard treatments can join this trial. They must have a life expectancy of at least 6 months and be in fairly good health otherwise (ECOG 0-1). Participants need to use two forms of birth control and cannot be pregnant. Those with brain metastases, recent other cancer therapies, severe medical conditions, or certain blood disorders are excluded.Check my eligibility

What is being tested?

[Ga-68]-PNT6555 and [Lu-177]-PNT6555 are being tested for safety and dosage in patients whose tumors over-express FAP. This early-phase study will help find the right dose for Phase 2 trials by gradually increasing amounts given to new groups of patients as safety is confirmed.See study design

What are the potential side effects?

Potential side effects aren't detailed here but may include typical reactions from radioligand therapies such as nausea, fatigue, kidney dysfunction, or myelosuppression (a decrease in bone marrow activity leading to fewer blood cells). The severity can vary based on individual patient factors.

FRONTIER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer has not responded to standard treatments or I cannot receive them.

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I am willing and able to follow the study's treatment and visit schedule.

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Your blood counts, liver function, and kidney function need to be within certain levels. You must have a certain type of scan that shows the cancer in your body. You must have already received treatment for your cancer and have no other options for a cure.

FRONTIER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug until disease progression (up to approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug until disease progression (up to approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until disease progression (up to approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment emergent adverse events

Secondary outcome measures

Adverse events for [Ga-68]-PNT6555

Biodistribution and radiation dosimetry of [Ga-68]-PNT6555 to normal organs.

Biodistribution and radiation dosimetry of [Lu-177]-PNT6555 to normal organs.

+2 more

Other outcome measures

Preliminary efficacy of [Lu-177]-PNT6555 based on change in biomarkers.

Preliminary efficacy of [Lu-177]-PNT6555 based on tumor response.

Radiation dosimetry of [Lu-177]-PNT6555 to tumor lesions.

+2 more

FRONTIER Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose escalationExperimental Treatment2 Interventions

Up to 30 patients with FAP-avid solid tumors.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

POINT BiopharmaLead Sponsor

5 Previous Clinical Trials

604 Total Patients Enrolled

Jessica JensenStudy DirectorPOINT Biopharma

1 Previous Clinical Trials

415 Total Patients Enrolled

Media Library

[Ga-68]-PNT6555 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05432193 — Phase 1

Soft Tissue Sarcoma Research Study Groups: Dose escalation

Soft Tissue Sarcoma Clinical Trial 2023: [Ga-68]-PNT6555 Highlights & Side Effects. Trial Name: NCT05432193 — Phase 1

[Ga-68]-PNT6555 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432193 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this clinical experiment?

"This medical study is enrolling 30 individuals aged 18 to 80 who have colorectal carcinoma. Furthermore, eligibility criteria includes: the use of two acceptable forms of contraception for 31 weeks (females) or 18 weeks (males), adenocarcinoma of the pancreas, high-grade soft tissue sarcoma excluding chordoma, platelet counts over 120 000/ mm^3 at dosing with transfusion allowed except during first dose administration, esophageal cancer in form of squamous cell carcinoma or adenocarcinoma but not gastroesophageal junction cancer, melan"

Answered by AI

What potential hazards are associated with [Ga-68]-PNT6555 for patients?

"As this is an early-phase trial with only minimal data available regarding efficacy and safety, [Ga-68]-PNT6555 received a score of 1."

Answered by AI

Are there any remaining slots available to prospective participants in this experiment?

"The current status of the clinical trial, as per information on clinicaltrials.gov, is actively recruiting participants. This medical experiment was first advertised on July 13th 2022 with the most recent update being September 21st 2022."

Answered by AI

Are there any age restrictions for individuals looking to participate in this trial?

"Adults aged 18 to 80 are eligible for enrollment in this trial. There is also a wealth of research available pertaining to minors and seniors; there are 223 studies on those under the age of 18, and 2010 related to elderly individuals over 65 years old."

Answered by AI

What is the current participant count for this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially posted on July 13th 2022, is actively recruiting for participants. The study aims to recruit a total of 30 patients from 3 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2022. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432193.

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