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 being developed for the treatment of Non-Small-Cell Lung cancer. It is currently being studied in a Phase 1 clinical trial for advanced solid tumors, including Non-Small-Cell Lung, Esophageal Cancer, and Cutaneous Melanoma.
PF-08046033 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.
PF-08046033 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the drug in advanced solid tumors.
PF-08046033 is being studied in a Phase 1 clinical trial with the identifier NCT07519655. This trial is recruiting 250 participants with advanced solid tumors, including Non-Small-Cell Lung cancer, Esophageal Cancer, and Cutaneous Melanoma, at sites in the United States, Puerto Rico, and South Korea.
No alternative names for PF-08046033 have been identified. The drug is known by its development code PF-08046033 and is being studied under this name in clinical trials.