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Pancreatic Ductal AdenocarcinomaPhase 1NCT05432193

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)

A Phase 1 study testing [Ga-68]-PNT6555 and [Lu-177]-PNT6555 in people with Pancreatic Ductal Adenocarcinoma and Colorectal Cancer, run by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[Ga-68]-PNT6555 and [Lu-177]-PNT6555
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesin 2 countries
Study dates
13 Jul 2022to 2 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (>18 years) male and female patients
  • 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.
  • Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
  • The patient has read, understood, and signed the written informed consent form(s)
  • 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
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  • 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)
  • Laboratory values at initial screening and also within three days prior to dosing of [Lu-177]-PNT6555:
  • Platelets greater than 120,000/ mm^3 at dosing. Transfusions allowed, but not for first dose
  • Neutrophils greater than 1500cells/mm^3
  • Hemoglobin:
  • Greater than 8.0 g/dL (only in Canada)
  • Greater than 8.5 g/dL (only in US)
  • Liver Chemistries:
  • ALT and AST < 2.5 x ULN or < 5 x ULN for patients with liver metastases
  • Bilirubin < 2 mg/dL (<34.2 µmol/L); patients with Gilbert's syndrome are permitted if bilirubin is < 3 mg/dL (< 51.3 µmol/L) (only in Canada).
  • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN); Total bilirubin ≤ 3 ULN is acceptable if a patient has Gilbert's provided that direct bilirubin ≤ 1.5 ULN (only in US)
  • Normal PT(secs) and aPTT(sec); normal INR (ratio). Patients taking anticoagulants must be in therapeutic range
  • Glomerular filtration rate defined as creatinine clearance >60 ml/min/1.73 m2 based on Cockcroft-Gault formula
  • Life expectancy of at least 6 months per investigator judgement
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1
  • Patients must have previously received treatment for their underlying disease and have no potentially curative options available
  • Positive [Ga-68]-PNT6555 PET/CT scan, defined as at least 50% of lesions with an SUVmax of 1.5 times or greater the SUVmean of the liver

Who cannot join

  • Patient has metastatic brain disease
  • 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
  • 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
  • Subject has received prior hemi- or total- body radiation
  • Subject has received whole brain radiation
  • History of any grade 4 myelosuppression, or grade 3 myelosuppression requiring more than 6 weeks recovery
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  • History of any kidney dysfunction (e.g., acute kidney failure, acute tubular necrosis (ATN)) for any reason (only in US)
  • Secondary malignancy that may interfere with the safety assessments of this study
  • 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
  • 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)
  • Patient has received any other investigational agents within 4 weeks of starting the study treatment
  • Patient has received systemic anti-cancer therapy:
  • Within 4 weeks or 5 half-lives, whichever is shorter of starting the study treatment; hormone maintenance therapy may be permitted with approval by the medical monitor if the patient is on a stable dose (preferred duration of a stable dose will be 4 weeks) (only in Canada)
  • Patient has received systemic anti-cancer therapy within 4 weeks of starting the study treatment; hormone maintenance therapy may be permitted with approval by the medical monitor if the patient is on a stable dose (preferred duration of a stable dose will be 4 weeks) (only in US)
  • Patient has undergone surgery within 4 weeks of starting the study treatment; exceptions are permitted with approval by Medical Monitor
  • Previous radioligand therapy
  • Previous Adoptive T-Cell Therapy (e.g. CAR-T therapy, TCR therapy, etc.)
  • Prolonged QT, defined as QTc > 470 ms regardless of sex (only in US)
  • In patients who have received prior EBRT, each case should be reviewed by the site Investigators to determine appropriateness of eligibility given potential increased risk for radiation toxicities. In patients who have received a prior course of radiation therapy adjacent to either kidney, the mean kidney dose from EBRT must be available to inform potential risk, otherwise the patient will be ineligible. Patients who have previously exceeded dose limits for critical organs from prior EBRT are ineligible (only in US)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Canada3 sites

  • CHUM - Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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.

Being tested
[Ga-68]-PNT6555, [Lu-177]-PNT6555
Keywords
radioligand therapy, FRONTIER, PNT6555, 177Lu-FAP, 68Ga-FAP, PDAC, CRC, Melanoma, STS, Esophageal cancer, fibroblast activation protein, FAP, FAPi, Lu-177, GA-68, HNSCC, Cholangiocarcinoma
Medical subject headings
Colorectal Neoplasms, Esophageal Neoplasms, Melanoma, Sarcoma, Squamous Cell Carcinoma of Head and Neck, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [Ga-68]-PNT6555Drug

    [Ga-68]-PNT6555 IV administered as imaging agent for PET/CT

  • [Lu-177]-PNT6555Drug

    Patients with FAP-avid disease as determined by the [Ga-68]-PNT6555 screening PET/CT will receive [Lu-177]-PNT6555 at a fixed dose level for up to 6 doses at an interval of 6 weeks between each dose.

Study groups in NCT05432193
Study groupRoleWhat they receive
Dose escalationExperimentalUp to 30 patients with FAP-avid solid tumors.
Receives: Drug: [Ga-68]-PNT6555; Drug: [Lu-177]-PNT6555

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment emergent adverse events

    Occurrence of Treatment emergent adverse events as per CTCAE v5.0

    Measured: From first dose of study drug through end of treatment (~24 weeks)

Secondary outcomes (5)

  1. Adverse events for [Ga-68]-PNT6555

    Occurrence of adverse events for [Ga-68]-PNT6555 as per CTCAE v5.0

    Measured: From first dose of imaging study drug through 7 days post dose

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

    Absorbed dose estimates (Gy) in normal organs for [Lu-177]-PNT6555

    Measured: From first dose of study drug through end of treatment (~24 weeks)

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

    Absorbed dose estimates (Gy) in normal organs for [Ga-68]-PNT6555

    Measured: From first dose of imaging study drug through 7 days post dose

  4. Detection of [Ga-68]-PNT6555 in tumor lesions

    Anatomic distribution of [Ga-68]-PNT6555

    Measured: From first dose of imaging study drug through 7 days post dose

  5. Uptake of [Ga-68]-PNT6555 in tumor lesions

    Maximum and average standardized uptake values of [Ga-68]-PNT6555 in tumor lesions

    Measured: From first dose of imaging study drug through 7 days post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start13 Jul 2022
  3. Primary completion10 Nov 2023
  4. Study completion2 Oct 2024

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432193
Sponsor's protocol ID
PNT6555-01
Status last verified
Jun 2025
First submitted
8 Jun 2022
Last updated
25 Jun 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [Ga-68]-PNT6555 and [Lu-177]-PNT6555 in people with Pancreatic Ductal Adenocarcinoma and Colorectal Cancer, run by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment emergent adverse events (time frame: From first dose of study drug through end of treatment (~24 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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