Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08046033 · 1 trial · 3 indications
Type, incidence, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v 5.0), seriousness, and relatedness of adverse events (AEs).
Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs
To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033
RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 1 intravenously (IV). |
| Part 1: Cohort 2 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 2 IV. |
| Part 1: Cohort 3 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 3 IV. |
| Part 1: Cohort 4 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 4 IV. |
| Part 1: Cohort 5 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 5 IV. |
| Part 1: Cohort 6 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 6 IV. |
| Part 1: Cohort 7 | EXPERIMENTAL | Participants will receive PF-08046033 dose level 7 IV. |
| Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC) | EXPERIMENTAL | PF-08046033: Specified dose IV on specified days |
| Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC) | EXPERIMENTAL | PF-08046033: Specified dose IV on specified days |
| Part 2: Cohort 3 (Cutaneous Melanoma) | EXPERIMENTAL | PF-08046033: Specified dose IV on specified days |
| Name | Type | Description |
|---|---|---|
| PF-08046033 | DRUG | Powder for solution for infusion. |
Inclusion Criteria: 1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma. 2. Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part...
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PF-08046033 is an investigational small molecule oncology drug being developed by Pfizer, Inc. (NYSE: PFE). It is in Phase 1 clinical development for advanced solid tumors, including non-small-cell lung cancer, esophageal cancer, and cutaneous melanoma. It has not been approved by the FDA and remains in clinical testing.
PF-08046033 is being studied in non-small-cell lung cancer as part of a Phase 1 trial in advanced solid tumors. It is investigational and has not been approved for any indication. The study also enrolls patients with esophageal cancer and cutaneous melanoma.
PF-08046033 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the Phase 1 clinical program evaluating the drug in advanced solid tumors.
PF-08046033 is in Phase 1 clinical development. It is an investigational small molecule and has not received FDA approval. The single active trial is currently recruiting participants.
PF-08046033 is being evaluated in one active Phase 1 trial, NCT07519655, titled a Phase 1 Study of PF-08046033 in Advanced Solid Tumors. The trial is recruiting up to 250 participants across the United States, France, Puerto Rico, South Korea, and Spain.
The Phase 1 trial of PF-08046033, NCT07519655, is a controlled study but is not randomized and not double-blind. It is an open-label design enrolling adults 18 years and older with advanced solid tumors, including non-small-cell lung cancer, esophageal cancer, and cutaneous melanoma.