PF-07257876
BiologicalCD47-PDL-1 bispecific antibody
NCT Number: NCT04881045
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CD47-PDL-1 bispecific antibody
Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)
DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
Time frame: Baseline through up to 2 years
AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relationship to study therapy.
Time frame: Baseline through up to 2 years
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Time frame: Baseline through up to 2 years or until disease progression
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Maximum observed plasma concentration of PF-07257876 (Cmax)
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Time to maximal observed plasma concentration of PF-07257876 (Tmax)
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Area under the concentration-time curve from time zero to the last quantifiable time point prior to the next dose.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Maximum observed steady state plasma concentration of PF-07257876 (Cmax, ss)
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss).
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Area Under the curve within one dose interval at steady state (AUCtau,ss)
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Incidence, titers, and duration (if data permit) of antidrug antibodies (ADA) and neutralizing antibodies against PF-07257876
Time frame: Baseline through Cycle 2 Day 15 (each cycle is 28 days)
Immune biomarker levels in archival biopsies and/or de novo and on-treatment tumor biopsies.
Time frame: Baseline through Cycle 2 Day 15 (each cycle is 28 days)
PD-L1 expression levels in pretreatment tumor biopsies
Time frame: Baseline through up to 2 years or until disease progression
Tumor response assessment based on RECIST 1.1
Time frame: Baseline through up to 2 years or until disease progression
DOR as assessed using RECIST 1.1
Time frame: Baseline through up to 2 years or until disease progression
PFS as assessed using RECIST 1.1
Time frame: Baseline through up to 2 years or until disease progression
TTP as assessed using RECIST 1.1
Time frame: Pre-dose on Day 1 at Cycles 1, 2, 3, 4, 5 and every third cycle thereafter (each cycle is 28 days) and End of Treatment visit, up to 2 years
PK assessment for PF-07257876
Time frame: Baseline through up to 2 years or until disease progression
Proportion of patients alive
Pfizer
Industry
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07257876 IN PATIENTS WITH ADVANCED OR METASTATIC TUMORS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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