Radiopharmaceutical

[Ga-68]-PNT6555 for Soft Tissue Sarcoma

Jewish General Hospital, Montréal, Canada
Targeting 7 different conditions[Ga-68]-PNT6555 +1 morePhase 1RecruitingResearch Sponsored by POINT Biopharma

Study 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.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Colorectal Cancer
  • Skin Cancer
  • Bile Duct Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Pancreatic Cancer
  • Esophageal Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have an advanced or spreading solid tumor that does not respond to the usual treatment, there is no approved treatment available, or you choose not to undergo the standard treatment.
Select...
You have already received treatment for your illness, and there are no more treatments that can cure your condition.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment2 Interventions
Up to 30 patients with FAP-avid solid tumors.

Find a site

Who is running the clinical trial?

POINT BiopharmaLead Sponsor
3 Previous Clinical Trials
563 Total Patients Enrolled
Jessica JensenStudy Director
POINT 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](https://www.withpower.com/clinical-trials/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
~4 spots leftby Dec 2023