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PF-08046033

Phase 1

Non-Small-Cell Lung | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

PF-08046033 · 1 trial · 3 indications

Phase 1 1
NCT07519655Phase 1 Study of PF-08046033 in Advanced Solid TumorsNon-Small-Cell Lung
RECRUITING250 Analytics
PHASE1RECRUITING
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Non-Small-Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Type, incidence and severity of participants with adverse events (AEs)
From the first day through 30-37 days after the last study treatment, up to approximately 1 year

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 of participants with laboratory abnormalities
From the first day through 30-37 days after the last study treatment, up to approximately 1 year

Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities

Number of participants with dose modifications
From the first day through 30-37 days after the last study treatment, up to approximately 1 year

Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs

Incidence of dose-limiting toxicities (DLTs)
From the first day through 30-37 days after the last study treatment, up to approximately 1 year

To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033

Recommended dose and schedule of PF-08046033 for expansion (RDE)
Up to 1 year

RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings

Secondary Endpoints

Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator
Up to 3 years
Duration of response (DOR) using RECIST v1.1 as assessed by investigator
Up to 3 years
Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator
Up to 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Cohort 1EXPERIMENTALParticipants will receive PF-08046033 dose level 1 intravenously (IV).
Part 1: Cohort 2EXPERIMENTALParticipants will receive PF-08046033 dose level 2 IV.
Part 1: Cohort 3EXPERIMENTALParticipants will receive PF-08046033 dose level 3 IV.
Part 1: Cohort 4EXPERIMENTALParticipants will receive PF-08046033 dose level 4 IV.
Part 1: Cohort 5EXPERIMENTALParticipants will receive PF-08046033 dose level 5 IV.
Part 1: Cohort 6EXPERIMENTALParticipants will receive PF-08046033 dose level 6 IV.
Part 1: Cohort 7EXPERIMENTALParticipants will receive PF-08046033 dose level 7 IV.
Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)EXPERIMENTALPF-08046033: Specified dose IV on specified days
Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)EXPERIMENTALPF-08046033: Specified dose IV on specified days
Part 2: Cohort 3 (Cutaneous Melanoma)EXPERIMENTALPF-08046033: Specified dose IV on specified days

Interventions

NameTypeDescription
PF-08046033DRUGPowder for solution for infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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...

Countries:United StatesPuerto RicoSouth Korea
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non-Small-Cell Lung")

Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07519655lastUpdatePostDate: changed
LOWAug 17, 2026NCT07519655lastUpdatePostDate: changed
LOWAug 17, 2026NCT07519655lastUpdatePostDate: changed
LOWJul 22, 2026NCT07519655lastUpdatePostDate: changed
LOWJul 22, 2026NCT07519655lastUpdatePostDate: changed

Frequently asked questions about PF-08046033

What is PF-08046033 used for?

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.

Who makes PF-08046033?

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.

What phase is PF-08046033 in?

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.

What clinical trials is PF-08046033 in?

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.

Is PF-08046033 the same as any other drug?

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.