Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08046876 · 1 trial · 13 indications
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.
Occurrence of DLTs as defined by the protocol
RDE will be based on cumulative safety, preliminary anti-tumor activity and pharmacokinetics findings
RP2D will be determined based on the cumulative safety, preliminary anti-tumor activity, and pharmacokinetics findings.
RP2D/RDE will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation | EXPERIMENTAL | Different groups of participants will receive different doses and/or schedules of the study drug |
| Part 2 Dose Expansion | EXPERIMENTAL | Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1 |
| Part 2 Dose Optimization | EXPERIMENTAL | Participants will be enrolled to 2 dosing regimens deemed to be safe in Part 1 |
| Part 3 - Combination Cohort 1 | EXPERIMENTAL | Participants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab |
| Part 3 - Combination Cohort 2 | EXPERIMENTAL | Participants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab and carboplatin |
| Part 3 - Combination Cohort 3 | EXPERIMENTAL | Participants with advanced urothelial cancer that has progressed after 1 to 2 prior lines of treatment in the metastatic/recurrent setting will receive PF-08046876 together with cisplatin |
| Part 3 - Combination Cohort 4 | EXPERIMENTAL | Participants with advanced urothelial cancer that has progressed after 1 to 2 prior lines of treatment in the metastatic/recurrent setting will receive PF-08046876 together with carboplatin |
| Part 3 - Combination Cohort 5 | EXPERIMENTAL | Participants with advanced urothelial cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab |
| Name | Type | Description |
|---|---|---|
| PF-08046876 | DRUG | Intravenous administration |
| Pembrolizumab | COMBINATION_PRODUCT | Intravenous administration |
| Cisplatin | COMBINATION_PRODUCT | Intravenous administration |
| Carboplatin | COMBINATION_PRODUCT | Intravenous administration |
Inclusion Criteria: * 18 years of age or older * Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas * Measurable disease * ECOG Performance status 0-1 * Part 1: progression or relapse following standard treatments * Part 2: maximum of 2 prior lines of systemic therapy in th...
| 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 |
PF-08046876 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors, including bladder cancer, urothelial carcinoma, non-small cell lung cancer, head and neck cancer, esophageal cancer, gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma.
PF-08046876 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.
PF-08046876 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. It is currently being evaluated in a Phase 1 study for safety and tolerability in patients with advanced solid tumors.
PF-08046876 is being studied in one active clinical trial, NCT07090499, which is recruiting participants. The trial is a Phase 1 study in people with advanced solid tumors and is enrolling up to 540 participants across the United States, Canada, China, Puerto Rico, Spain, and the United Kingdom.
No alternative names for PF-08046876 have been disclosed. The drug is identified solely by its code name PF-08046876 in clinical trial records and public information.