What side effects are associated with this type of intervention?

Common treatments for Soft Tissue Sarcoma (STS) include chemotherapy agents like doxorubicin and ifosfamide, targeted therapies such as pazopanib, and radiolabeled compounds. Chemotherapy often results in side effects like myelosuppression, alopecia, mucosal inflammation, and gastrointestinal issues. Targeted therapies, including antiangiogenic agents like pazopanib, can cause hypertension, hypothyroidism, and diarrhea. Radiolabeled compounds, similar to [Ga-68]-PNT6555 and [Lu-177]-PNT6555, may lead to radiation-related side effects such as fatigue, nausea, and potential damage to surrounding tissues. It is essential to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's needs.

What prior FDA approvals exist?

FDA-approved treatments for soft tissue sarcoma include pazopanib, a tyrosine kinase inhibitor targeting VEGF, which has shown efficacy in advanced cases. Additionally, eribulin mesylate has been approved for patients with advanced liposarcoma and leiomyosarcoma. While there is no direct mention of radiolabeled compounds targeting FAP over-expression like [Ga-68]-PNT6555 and [Lu-177]-PNT6555, these approvals highlight the ongoing exploration of targeted therapies in soft tissue sarcoma.

What other types of research exist?

Promising alternatives to [Ga-68]-PNT6555 and [Lu-177]-PNT6555 for Soft Tissue Sarcoma patients include [68Ga]/[90Y]FAPI-46, which targets fibroblast activation protein (FAP) and has shown high radiochemical purity and stability. Additionally, [64Cu]-PSMA-ALB-89, a PSMA-targeting PET radioligand, has demonstrated favorable in vivo stability and tissue distribution, making it a potential candidate for further optimization and clinical translation.

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Radiopharmaceutical

FAPi Radioligand Therapy for Solid Cancers (FRONTIER Trial)

Phase 1

Waitlist Available

Research Sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

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

Must not have

Subject has received prior hemi- or total- body radiation

Subject has received whole brain radiation

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new drugs on patients with specific solid tumors that have high levels of a protein called FAP. The goal is to see if these drugs are safe and to find the best dose for future studies. The drugs work by targeting the FAP protein on the cancer cells.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to half or all of my body.

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I have undergone whole brain radiation.

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My partner is pregnant, breastfeeding, or we plan to conceive during the study or within 18 weeks after the last dose.

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My cancer has spread to my brain.

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I have had kidney problems in the past.

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I have never had severe bone marrow suppression.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment emergent adverse events

Secondary study objectives

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 study objectives

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Soft Tissue Sarcoma (STS) include chemotherapy, surgery, and radiation therapy. Chemotherapy uses drugs to target and kill rapidly dividing cancer cells, while surgery involves the physical removal of the tumor. Radiation therapy employs high-energy particles to destroy cancer cells. Targeted radiotherapies, such as those using radiolabeled compounds like [Ga-68]-PNT6555 and [Lu-177]-PNT6555, focus on delivering radiation directly to cancer cells that over-express specific proteins like FAP, thereby minimizing damage to healthy tissues. This targeted approach is crucial for STS patients as it can enhance treatment efficacy and reduce side effects, improving overall outcomes.

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