Approval Probability
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ML Risk
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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
68Ga-FAP-2286 is an investigational small molecule being studied for use in solid tumors. It is currently in Phase 1 clinical development for the treatment of solid tumors, which are abnormal masses of tissue that can be cancerous or non-cancerous. The drug is being evaluated in a clinical trial setting.
68Ga-FAP-2286 is a small molecule that targets fibroblast activation protein (FAP), which is highly expressed in the stroma of many solid tumors. By binding to FAP, the drug is designed to deliver a therapeutic payload to the tumor microenvironment. This targeting mechanism is being investigated in Phase 1 trials.
68Ga-FAP-2286 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in solid tumors.
68Ga-FAP-2286 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities such as the FDA. The drug is being studied in a Phase 1 trial to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
68Ga-FAP-2286 is being evaluated in a Phase 1 clinical trial with the identifier NCT04939610. This trial is titled 'A Study of 177Lu-FAP-2286 in Advanced Solid Tumors' and is currently recruiting participants. The study is enrolling 222 patients across multiple countries, including the United States, Australia, Canada, France, Italy, and Spain.
68Ga-FAP-2286 and 177Lu-FAP-2286 are related but distinct compounds. 68Ga-FAP-2286 is a diagnostic imaging agent that uses gallium-68 for positron emission tomography (PET) imaging, while 177Lu-FAP-2286 is a therapeutic agent that uses lutetium-177 for targeted radiotherapy. Both target FAP and are being developed by Novartis for solid tumors.