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A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

ConditionsAdvanced/Metastatic Solid TumorsBladder CancerUrothelial CarcinomaAdvanced Non-Small Cell Lung CancerCarcinoma, Non Small Cell LungCarcinoma, Squamous Cell of Head and NeckHead and Neck CancerEsophageal CancerGastroesophageal Junction AdenocarcinomaEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaPancreatic AdenocarcinomaPancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.

The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas

Measurable disease

ECOG Performance status 0-1

Disqualifiers

Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )

Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion

Pulmonary disease meeting protocol exclusion

Other unacceptable abnormalities as defined by protocol

Trial design

Design model

Sequential

Treatments tested in this trial

  • PF-08046876

    Drug

    Intravenous administration

  • Pembrolizumab

    Combination product

    Intravenous administration

  • Cisplatin

    Combination product

    Intravenous administration

  • Carboplatin

    Combination product

    Intravenous administration

Treatment groups

540 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1 Dose EscalationExperimental treatment 1 intervention
Group B: Part 2 Dose ExpansionExperimental treatment 1 intervention
Group C: Part 2 Dose OptimizationExperimental treatment 1 intervention
Group D: Part 3 - Combination Cohort 1Experimental treatment 2 interventions
Group E: Part 3 - Combination Cohort 2Experimental treatment 3 interventions
Group F: Part 3 - Combination Cohort 3Experimental treatment 2 interventions
Group G: Part 3 - Combination Cohort 4Experimental treatment 2 interventions
Group H: Part 3 - Combination Cohort 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation

AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.

Time frame
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
2

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy

Occurrence of DLTs as defined by the protocol

Time frame
Baseline to end of DLT evaluation period
3

Part 1: Recommended Monotherapy Dose for Expansion

RDE will be based on cumulative safety, preliminary anti-tumor activity and pharmacokinetics findings

Time frame
Baseline to 30 days post last study drug administration
4

Part 2: Recommended Monotherapy Phase 2 Dose

RP2D will be determined based on the cumulative safety, preliminary anti-tumor activity, and pharmacokinetics findings.

Time frame
Baseline to 30 days post last study drug administration

Secondary outcomes

1

Objective Response Rate (ORR)

ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Time frame
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
2

Duration of Response (DOR)

DOR as defined per RECIST 1.1.

Time frame
From the date of the first objective response to the date of disease progression or death (approximately 2 years)
3

Progression Free Survival (PFS)

PFS as defined per RECIST 1.1.

Time frame
From Baseline to date of first disease progression or death (approximately 2 Years)
4

Overall Survival (OS)

OS defined as the time until death due to any cause.

Time frame
From baseline to up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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