Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FPI-2053 · 1 trial · 7 indications
Frequency, duration, and severity of AEs, DLTs, and changes in clinical, laboratory, and ECG parameters compared to baseline
Changes in uptake of \[111In\]-FPI-2107 and projected RAD of \[225Ac\]-FPI-2068 by imaging following the administration of varying doses of FPI-2053
Estimates of residence time and absorbed radiation doses to the whole body, organs, and selected regions of interest for \[111In\]-FPI-2107 and \[225Ac\]-FPI-2068.
Changes in uptake of \[111In\]-FPI- 2107 and projected RAD of \[225Ac\]-FPI-2068 by imaging following the administration of varying doses of FPI-2053
| Arm | Type | Description |
|---|---|---|
| Dose Exploration and Dose Escalation | EXPERIMENTAL | The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation FPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of \[225Ac\]-FPI-2068. \[225Ac\]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A. |
| Name | Type | Description |
|---|---|---|
| FPI-2053 | DRUG | FPI-2053 is a bispecific antibody that targets EGFR and cMET |
| [111In]-FPI-2107 | DRUG | \[111In\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053. Participants will have a fixed dose of \[111In\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053). |
| [225Ac]-FPI-2068 | DRUG | \[225Ac\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053. Participants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period. |
Key Inclusion Criteria: Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable. Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tole...
| 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 |
FPI-2053 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development as a potential oncology therapy.
FPI-2053 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.
FPI-2053 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.
FPI-2053 is being studied in a Phase 1 dose-escalation trial with the identifier NCT06147037. The trial is active but not recruiting and has an enrollment of 13 participants.
FPI-2053 is being studied in patients with advanced solid tumors, including metastatic colorectal carcinoma, head and neck squamous cell carcinoma, non-small cell lung cancer, pancreatic ductal adenocarcinoma, gastric cancer, and renal cell carcinoma.
The FPI-2053 clinical trial is being conducted in the United States and Canada. The study enrolls adults aged 18 years and older.