A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08098488 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS.
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08098488) in people with advanced solid tumors (cancer that cannot be removed with surgery or has spread to other parts of the body). PF-08098488 is being studied as a possible treatment for certain types of cancer. These include non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, and esophageal cancer. This study will also help researchers learn how the study medicine moves through and affects the body.
This study is seeking adults who:
- Have advanced non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, or esophageal cancer.
- Have received at least 1 previous treatment for their cancer.
- Have cancer that has grown, returned, or is no longer responding to available treatments.
All participants in this study will receive PF-08098488 as an IV infusion (given directly into a vein) at the study clinic. Researchers will study different dose levels and dosing schedules to find the dose that is safe and may work best. Participants will be monitored closely during treatment, especially after their first infusion. They may continue receiving the study medicine as long as their cancer is not getting worse and they are tolerating treatment.
The study includes a screening period of up to 28 days. Participants will have regular visits to the study clinic for treatment and health assessments. These assessments include scans to monitor the cancer and blood sample collection. Tumor tissue samples will also be collected when available or medically feasible. After treatment ends, participants will have a follow-up visit about 1 month later. They will then be contacted about every 12 weeks to check on their health.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Luoghi di studio
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49546
- Reclutamento
- START Midwest, LLC
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Sarah Cannon Research Institute - Pharmacy
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Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- SCRI Oncology Partners
-
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Texas
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San Antonio, Texas, Stati Uniti, 78229
- Reclutamento
- START San Antonio, LLC
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18 years of age or older
- Advanced non-small cell lung cancer, pancreatic ductal adenocarcinoma, gastric cancer (including gastroesophageal junction carcinoma), or esophageal cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
- Measurable disease
- Must have received at least 1 prior approved systemic therapy:
- Part 1: progression or relapse following standard treatments and have no other appropriate standard of care option.
- Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting.
- Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
- Consent to submit required pre-treatment tumor tissue as medically feasible
Exclusion Criteria:
- Received prior treatment with an antibody drug conjugate with an auristatin or microtubule inhibitor payload.
- Unacceptable renal, hepatic, hematologic, cardiologic, pulmonary, or abnormalities as defined by the protocol.
- Pre-existing sensory or motor neuropathy.
- Uncontrolled diabetes mellitus.
- Clinically significant and/ or symptomatic eye disease meeting protocol exclusion criteria.
- Pulmonary (lung) disease meeting protocol exclusion criteria.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Part 1 Dose Escalation
Different groups of participants will receive different doses and/or schedules of the study drug |
IV infusion |
|
Sperimentale: Part 2 Dose Expansion
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1 |
IV infusion |
|
Sperimentale: Part 2 Dose Optimization
Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1 |
IV infusion |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Adverse Events (AEs)
Lasso di tempo: Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
|
Number of participants with AEs, characterized by type, frequency, severity, seriousness, and relationship to study intervention during the AE evaluation period. |
Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
|
|
Part 1: Recommended Monotherapy Dose(s) for Expansion (RDEM)
Lasso di tempo: From first dose through completion of Part 1, an average of 1 year
|
From first dose through completion of Part 1, an average of 1 year
|
|
|
Part 2: Recommended Monotherapy Dose for Further Development
Lasso di tempo: From first dose through completion of Part 2, an average of 2 years
|
From first dose through completion of Part 2, an average of 2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective Response Rate (ORR)
Lasso di tempo: From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
|
Percentage of participants with a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator. |
From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
|
|
Duration of Response (DOR)
Lasso di tempo: From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. |
From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
|
Progression Free Survival (PFS)
Lasso di tempo: From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
PFS as defined per RECIST 1.1. |
From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
|
Overall Survival (OS)
Lasso di tempo: From first dose until death due to any cause, up to approximately 3 years
|
Time in weeks from the start of study treatment to date of death due to any cause. |
From first dose until death due to any cause, up to approximately 3 years
|
|
Maximum Observed Serum Concentration (Cmax)
Lasso di tempo: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
|
|
Area under the concentration-time curve (AUC)
Lasso di tempo: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
|
|
Time to Maximum Observed Serum Concentration (Tmax)
Lasso di tempo: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
|
|
Number of Participants With Anti-drug Antibody (ADA) against PF-08098488
Lasso di tempo: Start of study treatment to 30 days after last dose of study drug administration
|
Start of study treatment to 30 days after last dose of study drug administration
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Processi patologici
- Neoplasie per sede
- Neoplasie
- Malattie delle vie respiratorie
- Neoplasie per tipo istologico
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie dello stomaco
- Malattie polmonari
- Neoplasie delle ghiandole endocrine
- Neoplasie della testa e del collo
- Malattie pancreatiche
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Processi neoplastici
- Malattie esofagee
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Condizioni patologiche, segni e sintomi
- Neoplasie allo stomaco
- Carcinoma
- Neoplasie polmonari
- Neoplasie esofagee
- Metastasi neoplastica
- Neoplasie pancreatiche
- Carcinoma, polmone non a piccole cellule
Altri numeri di identificazione dello studio
- C6261001
- CEACAM5 EC4V (Altro identificatore: Alias Study Number)
- 2026-527660-32-00 (Identificatore di registro: CTIS (EU))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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