Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181788
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 14, 2019
First Posted Date  ICMJE November 29, 2019
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE March 18, 2020
Estimated Primary Completion Date May 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Phase 1b: Number of participants with Dose-Limiting Toxicities (DLT) [ Time Frame: At the end of cycle 1 (28 days) for Arm A1 and (42 days) for Arm B1 ]
    A DLT is any of a predefined set of unacceptable adverse events that are observed and that are related to the investigational agent.
  • Phase 2: AUCτ of PF-06801591 at steady state, at Week 12 [ Time Frame: Arm A2 (each cycle/28 days): Day 1, 8, 15, 22 of Cycles 1 and 4, Day 1 of Cycles 2, 3, 5, 6, 8, 10 and EOT (up to 24 months). Arm B2 (each cycle/ 42 days): Day 1, 8, 15, 29 of Cycles 1 and 3, Day 1 of Cycles 2, 4, 5, 7 and EOT (up to 24 months) ]
    AUCτ is defined as area under the concentration-time curve during the dosing interval (τ).
  • Phase 2: Ctrough of PF-06801591 at steady state, at Week 12 [ Time Frame: Arm A2 (each cycle/28 days): Day 1, 8, 15, 22 of Cycles 1 and 4, Day 1 of Cycles 2, 3, 5, 6, 8, 10 and EOT (up to 24 months). Arm B2 (each cycle/ 42 days): Day 1, 8, 15, 29 of Cycles 1 and 3, Day 1 of Cycles 2, 4, 5, 7 and EOT (up to 24 months) ]
    Ctrough is defined as the concentration at the end of PF-06801591 dosing interval.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Number of participants with Treatment-Emergent Adverse Events [ Time Frame: Baseline and up to 90 days post treatment period ]
    Assessment of the overall safety and tolerability.
  • Number of participants with laboratory abnormalities [ Time Frame: Baseline and up to 30 days post treatment period ]
    Assessment of the overall safety and tolerability.
  • Pharmacokinetic parameters: AUC after first dose [ Time Frame: Arms A1/A2 (each cycle/28 days): Day 1, 8, 15, 22 of Cycles 1 and 4, Day 1 of Cycles 2, 3, 5, 6, 8, 10 and EOT (up to 24 months). Arms B1/B2 (each cycle/42 days): day 1, 8, 15, 29 of Cycles 1 and 3, Day 1 of Cycles 2, 4, 5, 7 and EOT (up to 24 months) ]
    AUC is defined as the area under the curve after the first dose.
  • Pharmacokinetic parameters: Ctrough after first dose [ Time Frame: Arms A1/A2 (each cycle/28 days): Day 1, 8, 15, 22 of Cycles 1 and 4, Day 1 of Cycles 2, 3, 5, 6, 8, 10 and EOT (up to 24 months). Arms B1/B2 (each cycle/42 days): day 1, 8, 15, 29 of Cycles 1 and 3, Day 1 of Cycles 2, 4, 5, 7 and EOT (up to 24 months) ]
    Ctrough after first dose is defined as the concentration at the end of the first dosing interval of PF-06801591.
  • Pharmacokinetic parameters: Ctrough at steady State [ Time Frame: Arms A1/A2 (each cycle/28 days): Day 1, 8, 15, 22 of Cycles 1 and 4, Day 1 of Cycles 2, 3, 5, 6, 8, 10 and EOT (up to 24 months). Arms B1/B2 (each cycle/42 days): day 1, 8, 15, 29 of Cycles 1 and 3, Day 1 of Cycles 2, 4, 5, 7 and EOT (up to 24 months) ]
    Ctrough at steady state is defined as the concentration at the end of PF-06801591 dosage interval at steady state.
  • Anti-Drug Antibody (ADA) levels of PF-06801591/Neutralizing antibodies titers for PF-06801591 [ Time Frame: Arm A1 and Arm A2 (each cycle is 28 days): On day 1 of cycles 1, 2, 3, 4, 6, 8, 10 and EOT (up to 24 months). Arm B1 and Arm B2 (each cycle is 42 days): On day 1 of cycles 1, 2, 3, 4, 5, 7 and EOT (up to 24 months) ]
    Immunogenicity assessment of PF-06801591.
  • Number of participants with Objective Response [ Time Frame: Every 12 weeks (up to 24 months) ]
    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of first dose of study treatment (Phase 1b) or randomization (Phase 2) until the date of the first documentation of progression of disease.
  • Time to Response (TTR) [ Time Frame: Every 12 weeks (up to 24 months) ]
    TTR is the time from first dose of study treatment (Phase 1b) or randomization (Phase 2) to the date of first documentation of objective tumor response (CR or PR) by RECIST 1.1 that is subsequently confirmed.
  • PD-L1 expression in baseline [ Time Frame: Baseline ]
    Correlation(s) between PD-L1 expression in baseline tumor tissue and pharmacodynamic markers and/or clinical activity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
Official Title  ICMJE A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies
Brief Summary

This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies.

This study consists of 2 parts:

Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignancies
  • Non-small-cell Lung Cancer
Intervention  ICMJE Drug: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
Study Arms  ICMJE
  • Experimental: Arm A1 (Phase 1b)
    Intervention: Drug: PF-06801591
  • Experimental: Arm B1 (Phase 1b)
    Intervention: Drug: PF-06801591
  • Experimental: Arm A2 (Phase 2)
    Intervention: Drug: PF-06801591
  • Experimental: Arm B2 (Phase 2)
    Intervention: Drug: PF-06801591
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2021)
156
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)
102
Estimated Study Completion Date  ICMJE May 7, 2025
Estimated Primary Completion Date May 6, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18 years (≥ 20 years in Japan; ≥ 19 years in South Korea)
  • Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow function, renal and liver functions Phase 1b
  • Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent
  • Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2
  • Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC
  • EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted
  • Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score [TPS] ≥1%) or unknown are eligible
  • Up to 1 line of prior therapy in advanced or metastatic disease settings allowed
  • Participant should not have received prior treatment with anti PD-1/PD-L1 drugs
  • At least one measurable lesion as defined by RECIST version 1.1

Exclusion Criteria:

  • Participants with known symptomatic brain metastases requiring steroids
  • Participants with Interstitial Lung Disease history or complication
  • Q-T interval corrected for heart rate QTc > 450 msec for male participants or QTc > 470 msec for female participants or QTc > 480 msec in participants with right bundle branch block.
  • Hypertension that cannot be controlled by medications (eg, systolic > 150 mmHg and diastolic > 90 mmHg) despite optimal medical therapy.
  • Known or suspected hypersensitivity to active ingredient or excipients of the study drug.
  • History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome [CRS]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only).
  • Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE China,   Japan,   Korea, Republic of,   Russian Federation,   Taiwan,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181788
Other Study ID Numbers  ICMJE B8011007
2019-003818-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP