Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.
The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.
The study has two parts:
In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.
Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.
Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.
Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).
Participants must have measurable disease.
Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
Disqualifiers
Participants with known clinically active central nervous system (CNS) metastases.
Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.
Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.
Untreated clinically significant thromboembolic disease.
Trial design
Design model
Sequential
Treatments tested in this trial
PF-08046033
DrugPowder for solution for infusion.
Treatment groups
250 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Part 1: Cohort 1Experimental treatment 1 intervention
Group B: Part 1: Cohort 2Experimental treatment 1 intervention
Group C: Part 1: Cohort 3Experimental treatment 1 intervention
Group D: Part 1: Cohort 4Experimental treatment 1 intervention
Group E: Part 1: Cohort 5Experimental treatment 1 intervention
Group F: Part 1: Cohort 6Experimental treatment 1 intervention
Group G: Part 1: Cohort 7Experimental treatment 1 intervention
Group H: Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)Experimental treatment 1 intervention
Group I: Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)Experimental treatment 1 intervention
Group J: Part 2: Cohort 3 (Cutaneous Melanoma)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Type, incidence and severity of participants with adverse events (AEs)
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).
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 1 year2
Type, incidence, and severity of participants with laboratory abnormalities
Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 1 year3
Number of participants with dose modifications
Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 1 year4
Incidence of dose-limiting toxicities (DLTs)
To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 1 yearSecondary outcomes
1
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator
Objective response defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1, from the date of first dose until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurs first.
Time frame
Up to 3 years2
Duration of response (DOR) using RECIST v1.1 as assessed by investigator
DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.
Time frame
Up to 3 years3
Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.
Time frame
Up to 3 years4
Overall survival (OS) using RECIST v1.1 as assessed by investigator
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame
Up to 3 years Source ClinicalTrials.gov