What side effects are associated with this type of intervention?

Common treatments for solid tumors, including radiolabeled agents like FAP-2286, can cause side effects such as nausea, vomiting, fatigue, and bone marrow suppression. Chemotherapy often leads to hair loss, mucositis, and increased infection risk. Targeted therapies may cause skin rashes, hypertension, and liver dysfunction, while immunotherapies can result in immune-related adverse events like colitis, pneumonitis, and endocrinopathies.

What prior FDA approvals exist?

FDA approvals for the treatment of solid tumors have included various targeted therapies and immunotherapies. For instance, drugs like pembrolizumab and nivolumab, which are immune checkpoint inhibitors, have been approved for multiple solid tumors. Additionally, radiolabeled agents such as Lutetium Lu 177 dotatate have been approved for targeting specific receptors on tumor cells, similar to the investigational Radiolabeled FAP-2286, which targets FAP on cancer-associated fibroblasts. These treatments aim to improve detection and therapeutic outcomes in metastatic cancer.

What other types of research exist?

Promising alternatives to Radiolabeled FAP-2286 for imaging metastatic cancer in solid tumors include 68Ga-PSMA PET/CT, which is highly effective in prostate cancer, and 18F-fluciclovine PET/CT, which is used for detecting recurrent prostate cancer. Additionally, FDG-PET combined with immune checkpoint inhibitors is being explored for monitoring treatment response in cancers such as melanoma.

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FAP-2286 Imaging for Cancer

Phase 1

Recruiting

Led By Thomas Hope, MD

Research Sponsored by Thomas Hope

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer.

Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging dye that helps doctors see cancer spread in patients with various solid tumors. The dye sticks to a specific protein in cancer cells and lights up on scans.

Who is the study for?

This trial is for adults with solid tumors, including specific cancers like breast, pancreatic, prostate, bladder, or colon cancer. Participants may be at initial high-risk stages or post-treatment with a risk of recurrence. They must understand and sign consent.

What is being tested?

The trial tests new imaging agents (68Ga- and 64Cu-FAP-2286) that bind to proteins often found in solid tumors. It aims to see how well these tracers can detect metastatic cancer using PET scans in various patient groups.

What are the potential side effects?

Potential side effects are not detailed but may include reactions related to the injection of radiolabeled agents used for PET imaging such as discomfort at the injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is one of the following types: breast, pancreatic, sarcoma, prostate (castrate-resistant), bladder, or colon.

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My scans show cancer has spread to other parts or bones.

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My cancer has not spread to other parts of my body or bones.

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My cancer is confirmed by lab tests and is not one of the previously mentioned types.

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I am 18 years old or older.

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My cancer is in the head and neck or bladder, confirmed by a pathology report.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Therapeutic procedure

Positron-Emission Tomography

Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Participants without metastatic disease (Cohort 3)Experimental Treatment3 Interventions

Participants without metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if if clinically indicated.

Group II: Participants with metastatic disease (Cohort 2)Experimental Treatment3 Interventions

Participants with metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if clinically indicated.

Group III: CLOSED - 68Ga-Dosimetry population (Cohort 1a)Experimental Treatment2 Interventions

PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FAP-2286. Contrast may be administered if clinically indicated.

Group IV: CLOSED - 64Cu-Dosimetry population (Cohort 1b)Experimental Treatment2 Interventions

PET imaging will begin 60±15 minutes, 240±30 minutes after injection,and 24±2 hours after injection of 64Cu-FAP-2286. Contrast may be administered if clinically indicated.

0 / 6Eligibility 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 solid tumors often involve targeted therapies and immunotherapies. Radiolabeled agents like FAP-2286 bind to specific proteins such as Fibroblast Activation Protein (FAP) on cancer-associated fibroblasts, allowing for precise imaging and targeted treatment of metastatic cancer. Tyrosine kinase inhibitors block signals that promote tumor cell growth and survival, while immunotherapies enhance the body's immune response against cancer cells. These approaches are significant for solid tumor patients as they provide more personalized and effective treatment options with potentially fewer side effects compared to traditional chemotherapy.

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