Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
NCT04181788
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
- 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.
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Descriptive Information | |||||||
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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 |
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Intervention ICMJE | Drug: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2. | ||||||
Study Arms ICMJE |
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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 | 126 | ||||||
Original Estimated Enrollment ICMJE | 102 | ||||||
Estimated Study Completion Date ICMJE | April 25, 2025 | ||||||
Estimated Primary Completion Date | April 24, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | 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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |