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

CompletedPhase 1, Phase 2

Sponsor: Pfizer

Conditions: Advanced Malignancies, Non-small-cell Lung Cancer

Interventions: PF-06801591

Countries: China, Japan, Russia, South Korea, Taiwan, Ukraine

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (49)

Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Nanjing, Jiangsu, China
Shanghai, Shanghai Municipality, China
Chuo-ku, Tokyo, Japan
Saint Petersburg, Pesochny, Russia
Pushkin, Sankt-Peterburg, Russia
Pyatigorsk, Stavropol Kray, Russia
Yaroslavl, Yaroslavl Oblast, Russia
Chelyabinsk, Russia
Chelyabinsk, Russia
Kaliningrad, Russia
Kaliningrad, Russia
Kopeysk, Russia
Orenburg, Russia
Pesochny, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Samara, Russia
Samara, Russia
Seongnam-si, Gyeonggi-do, South Korea
Incheon, South Korea
Seoul, South Korea
Seoul, South Korea
Kaohsiung City, Taiwan
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