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

NCT04181788 | Active Not Recruiting Phase 1 Results FDA Drug

• 2 other identifiers: B80110072019-003818-14
• Study Type: interventional
• Target: 155
• Locations: 6 countries
• Sites: 48

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.

Conditions

Advanced Malignancies; Non-small-cell Lung Cancer

Keywords

Advanced solid tumors; NSCLC

Outcome Measures

Primary Outcomes (3)

• Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)

  This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with first line (1L) and second line (2L) non-small cell lung cancer (NSCLC) (Phase 2). For the Phase 1b, any of the following AEs occurring during the DLT observation period (the first cycle of treatment) which were attributable to the investigational product were classified as DLTs: Grade 5 AE not clearly due to the underlying disease or extraneous causes; Hematologic toxicity; Non-Hematologic Toxicity; Delay of ≥ 3 weeks in receiving the next scheduled administration due to persisting treatment-related toxicities.

  Phase 1b: at the end of cycle 1 (28 days) for the PF-06801591 300 mg SC Q4W arms, and (42 days) for the PF-06801591 600 mg SC Q6W arms

• Phase 2: AUCτ of PF-06801591 at Steady State

  This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCτ is area under the plasma concentration-time profile from time zero to the next dose (at steady state, starting at Week 12). (τ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen)

  Phase 2: Cycle 4 Day 1, 8, 15, 22 and Cycle 5 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1, 8, 15, 29 and Cycle 4 Day 1 for the PF-06801591 600 mg SC Q6W arm

• Phase 2: Ctrough of PF-06801591 at Steady State, at Week 12

  This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12)

  Phase 2: Cycle 4 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1 for the PF-06801591 600 mg SC Q6W arm

Secondary Outcomes (9)

• Number of Participants With Treatment-Emergent Adverse Events

  Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).

• Number of Participants With Laboratory Abnormalities

  Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).

• Pharmacokinetic Parameters: AUCτ After First Dose

  Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Cycle 1 Day 1, 8, 15, 22, Cycle 2 Day 1; for the PF-06801591 600 mg SC Q6W arms, Cycle 1 Day 1, 8, 15, 29, Cycle 2 Day 1

• Pharmacokinetic Parameters: Ctrough After First Dose

  Phase 1b/2: Cycle 2 Day 1 for all Arms

• Pharmacokinetic Parameters: Ctrough at Steady State

  Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Day 1 of Cycle 4; for the PF-06801591 600 mg SC Q6W arms, Day 1 of Cycle 3

Study Arms (4)

Arm A1 (Phase 1b)

EXPERIMENTAL

Drug: PF-06801591

Arm B1 (Phase 1b)

EXPERIMENTAL

Drug: PF-06801591

Arm A2 (Phase 2)

EXPERIMENTAL

Drug: PF-06801591

Arm B2 (Phase 2)

EXPERIMENTAL

Drug: PF-06801591

Interventions

PF-06801591 DRUG

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

Arm A1 (Phase 1b); Arm A2 (Phase 2); Arm B1 (Phase 1b); Arm B2 (Phase 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (48)

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 201107, China

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Russian Research Centre for Radiology and Surgical Technologies

Saint Petersburg, Pesochny, 197758, Russia

Location

Private Medical Institution "Euromedservice"

Pushkin, Sankt-Peterburg, 196603, Russia

Location

Klinika UZI 4D, LLC

Pyatigorsk, Stavropol Kray, 357502, Russia

Location

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

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

Evimed Llc

Chelyabinsk, 454048, Russia

Location

Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

Chelyabinsk, 454087, Russia

Location

Ars Medika Center, LLC

Kaliningrad, 236006, Russia

Location

GBUZ Regional Clinical Hospital of Kaliningrad region

Kaliningrad, Russia

Location

Enlimed Llc

Kopeysk, 456620, Russia

Location

Orenburg Regional Clinical Oncological Dispensary

Orenburg, 460021, Russia

Location

Russian Scientific Center For Radiology and Surgical Technologies

Pesochny, 197758, Russia

Location

LLC Medical Center "Magnit"

Saint Petersburg, 190005, Russia

Location

Llc "Mss"

Saint Petersburg, 191025, Russia

Location

North-West Medical Center

Saint Petersburg, 191119, Russia

Location

Road clinical clinic of JSC "RZD"

Saint Petersburg, 192007, Russia

Location

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

Saint Petersburg, 195271, Russia

Location

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

Saint Petersburg, 195271, Russia

Location

LLC "Diagnostic center "Energo"

Saint Petersburg, 196247, Russia

Location

Medical University REAVIZ

Samara, 443001, Russia

Location

Medical University REAVIZ

Samara, 443011, Russia

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21656, South Korea

Location

Severance Hospital, Yonsei Univ. Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Limited Liability Company "MedX-ray International Group"

Pliuty Village, Kyiv Oblast, Ukraine

Location

Asklepion Medical Center

Khodosovka, Kyivska Oblast, 08173, Ukraine

Location

"Medeya Sumy" LLC

Sumy, Sumska Oblast, 40021, Ukraine

Location

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

Dnipro, 49102, Ukraine

Location

Llc "Mdc Expert"

Dnipro, 49102, Ukraine

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kirovohrad, 25006, Ukraine

Location

Medical centre "Verum" Limited Liability Company

Kyiv, 03039, Ukraine

Location

Vita Сom LLC

Kyiv, 03141, Ukraine

Location

The State Institution "Romodanov Neurosurgery Institute,

Kyiv, 04050, Ukraine

Location

Llc Medical Centre

Odesa, 65006, Ukraine

Location

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

Odesa, 65025, Ukraine

Location

Llc Lidermed

Odesa, 65062, Ukraine

Location

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

Sumy, 40022, Ukraine

Location

Llc Medical Center Diamed

Uzhhorod, 88000, Ukraine

Location

MNPE Central City Clinical Hospital of Uzhhorod City Council

Uzhhorod, 88000, Ukraine

Location

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

Zhytomyr, 10002, Ukraine

Location

Related Publications (1)

• Penkov K, Bondarenko I, Saenko DV, Kulyaba Y, Guo J, Gong Y, Yamamoto N, Hotko YS, Boyko V, Fadeeva NV, Ursol GM, Ahn HK, Kislov NV, Shen CI, Davis C, Kowalski K, Michelon E, Pavlov D, Hirohashi T, Cho BC. Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. Ther Adv Med Oncol. 2024 Sep 11;16:17588359241274592. doi: 10.1177/17588359241274592. eCollection 2024.

  PMID: 39281971 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 29, 2019
• Study Start: March 18, 2020
• Primary Completion: March 3, 2022
• Study Completion (Estimated): June 9, 2026
• Last Updated: April 27, 2026
• Results First Posted: May 8, 2023

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (4); TW (2); RU (20); JP (1); UA (17); CN (4)