Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07519655 | Phase 1 Study of PF-08046033 in Advanced Solid Tumors | PHASE1 | RECRUITING | 250 | — | — | Apr 8, 2026 | Jul 14, 2029 | Apr 23, 2026 | 6 | United States, Puerto Rico |
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...