Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT04181788

PHASE1/PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

155

Start Date

2020-03-18

Completion Date

2026-06-09

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Advanced Malignancies Non-small-cell Lung Cancer

Interventions

DRUG

PF-06801591

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.

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.

Locations (48)

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Russian Research Centre for Radiology and Surgical Technologies

Saint Petersburg, Pesochny, Russia

Private Medical Institution "Euromedservice"

Pushkin, Sankt-Peterburg, Russia

Klinika UZI 4D, LLC

Pyatigorsk, Stavropol Kray, Russia

State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital"

Yaroslavl, Yaroslavl Oblast, Russia

Evimed Llc

Chelyabinsk, Russia

Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

Chelyabinsk, Russia

Ars Medika Center, LLC

Kaliningrad, Russia

GBUZ Regional Clinical Hospital of Kaliningrad region

Kaliningrad, Russia

Enlimed Llc

Kopeysk, Russia

Orenburg Regional Clinical Oncological Dispensary

Orenburg, Russia

Russian Scientific Center For Radiology and Surgical Technologies

Pesochny, Russia

LLC Medical Center "Magnit"

Saint Petersburg, Russia

Llc "Mss"

Saint Petersburg, Russia

North-West Medical Center

Saint Petersburg, Russia

Road clinical clinic of JSC "RZD"

Saint Petersburg, Russia

NS HI "Road Clinical Hospital of JSC "Russian Railways""

Saint Petersburg, Russia

Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg

Saint Petersburg, Russia

LLC "Diagnostic center "Energo"

Saint Petersburg, Russia

Medical University REAVIZ

Samara, Russia

Medical University REAVIZ

Samara, Russia

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Severance Hospital, Yonsei Univ. Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Limited Liability Company "MedX-ray International Group"

Pliuty Village, Kyiv Oblast, Ukraine

Asklepion Medical Center

Khodosovka, Kyivska Oblast, Ukraine

"Medeya Sumy" LLC

Sumy, Sumska Oblast, Ukraine

Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council

Dnipro, Ukraine

Llc "Mdc Expert"

Dnipro, Ukraine

Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC"

Ivano-Frankivsk, Ukraine

Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center

Kirovohrad, Ukraine

Medical centre "Verum" Limited Liability Company

Kyiv, Ukraine

Vita Сom LLC

Kyiv, Ukraine

The State Institution "Romodanov Neurosurgery Institute,

Kyiv, Ukraine

Llc Medical Centre

Odesa, Ukraine

Municipal Non-profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council

Odesa, Ukraine

Llc Lidermed

Odesa, Ukraine

Municipal Non Profit enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Center"

Sumy, Ukraine

Llc Medical Center Diamed

Uzhhorod, Ukraine

MNPE Central City Clinical Hospital of Uzhhorod City Council

Uzhhorod, Ukraine

Мunicipal non-profit enterprise "Zhytomyr Regional Oncology Dispensary" of Zhytomyr Regional Council

Zhytomyr, Ukraine

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (48)