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68Ga-FAP-2286 · 1 trial · 1 indication
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D
Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. A confirmed CR or PR is a response that is maintained and documented on a subsequent tumor assessment no less than 28 days after the initial response. For Phase 2, ORR defined as the frequency and percentage of participants with a best confirmed response of CR or PR will be analyzed.
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)
| Arm | Type | Description |
|---|---|---|
| Phase 1: Dose Escalation | EXPERIMENTAL | Up to 30 patients with solid tumors. |
| Phase 2: Specific Solid Tumors | EXPERIMENTAL | Up to 192 participants treated with \[177Lu\]Lu-FAP-2286 in tumor-specific participant groups in monotherapy and in combination with chemotherapy. |
| Name | Type | Description |
|---|---|---|
| 68Ga-FAP-2286 | DRUG | 68Ga-FAP-2286 IV administered as imaging agent for PET scan. |
| 177Lu-FAP-2286 | DRUG | Phase 1: Patients with positive uptake of 68Ga-FAP- 2286 will receive a fixed dose of 177Lu-FAP-2286 IV administered every 6 weeks for a maximum of 6 doses. Doses range between 3.7 and 9.25 GBq (100-250 mCi). Phase 2: Monotherapy: Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D determined in Phase 1 dose escalation in every 4 weeks. Combination therapy: Patients with positive uptake of 68Ga FAP 2286 will receive 177Lu-FAP-2286 based on dose escalation (starting with dose level 1) followed by dose expansion at selected dose. |
Inclusion Criteria: Eligible participants must meet the following inclusion criteria. The criteria below apply to participants enrolling in Phase 1 and Phase 2, unless otherwise specified. 1. Have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Info...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
68Ga-FAP-2286 is an investigational small molecule imaging agent being developed by Novartis AG for solid tumors. It is a gallium-68 labeled radiotracer designed to bind fibroblast activation protein, or FAP, which is expressed in the tumor microenvironment. It is used in PET imaging to visualize FAP-positive tumors.
68Ga-FAP-2286 targets fibroblast activation protein, or FAP, a protein highly expressed in the stroma of many solid tumors. By binding to FAP, the gallium-68 labeled tracer allows positron emission tomography (PET) imaging of FAP-expressing tumor tissue. This targeting approach is being studied for tumor detection and characterization.
68Ga-FAP-2286 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. Novartis is evaluating the agent in oncology, specifically for solid tumors.
68Ga-FAP-2286 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority. The Phase 1 program is currently recruiting participants with advanced solid tumors.
68Ga-FAP-2286 is being studied in the Phase 1 trial NCT04939610, titled "A Study of 177Lu-FAP-2286 in Advanced Solid Tumors." The trial is recruiting and has an estimated enrollment of 222 participants. It is being conducted in the United States, Australia, Canada, France, Italy, and Spain.