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

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

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.

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.