Study on 177Lu-FAP-2286 for Advanced Solid Tumors

Program Overview

This study is exploring a new treatment, 177Lu-FAP-2286, which targets a protein called FAP found on cancer cells and surrounding tissues. The study is divided into two phases. Phase 1 focuses on finding a safe dose for the treatment in patients with solid tumors that express FAP. Phase 2 evaluates how well the treatment works in patients with pancreatic, non-small cell lung, and breast cancers, both alone and with chemotherapy. Participants will be selected based on imaging tests that show FAP expression in their tumors.

Description

Screening Period:

Before starting the treatment, participants will undergo various tests, including scans and blood tests, to ensure they meet the study requirements. They will also need to provide a sample of their tumor tissue if available. In Phase 1, additional imaging tests will be done.

Treatment Period:

Participants will receive the treatment 177Lu-FAP-2286 through an IV. In Phase 1, the treatment is given every 6 weeks, up to 6 times. In Phase 2, it is given every 4 weeks. Participants will be monitored for safety and how well the treatment is working. The treatment will continue until the maximum number of doses is reached, the cancer progresses, or the participant can no longer tolerate the treatment.

End of Treatment (EOT) Visit:

After the last dose, participants will have a follow-up visit to check their health and the effects of the treatment.

Post-treatment Safety Follow-up:

In Phase 2, participants will have a safety check 6 weeks after their last treatment.

Long-term Follow-up (LTFU) Period:

Participants will continue to have regular health checks every few months for up to 5 years to monitor their safety, disease status, and survival.

Inclusion Criteria:

• Must be 18 years or older.
• Must agree to participate and provide a tumor sample if available.
• Must have good organ function and meet specific health criteria.
• Must have a life expectancy of at least 6 months.
• Must have measurable cancer that meets certain size criteria.
• For Phase 1: Must have advanced solid tumors that have not responded to other treatments.
• For Phase 2: Must have specific types of cancer (pancreatic, non-small cell lung, or breast cancer) that have progressed after previous treatments.

Exclusion Criteria:

• Cannot have other active cancers, except for certain low-risk types.
• Cannot have untreated or symptomatic brain metastases.
• Cannot have received certain cancer treatments recently.
• Cannot have significant heart problems or other serious health issues.
• Cannot be pregnant or planning to become pregnant during the study.
• Cannot have severe infections or other conditions that may interfere with the study.

Eligibility Criteria