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    DRUG:

    sasanlimab (PF-06801591)

    i
    Other names: PF06801591, PF 06801591, RN888, RN 888, PF-06801591, PF-6801591, PF6801591, PF 6801591, RN-888
    Company:
    Pfizer
    Drug class:
    PD1 inhibitor
    Related drugs:
    12d
    A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=140 --> 5 | Trial completion date: Feb 2028 --> Mar 2025 | Trial primary completion date: Feb 2027 --> Mar 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    sasanlimab (PF-06801591)
    12d
    LTbR: A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination (clinicaltrials.gov)
    P1, N=4, Terminated, Pfizer | Trial completion date: Aug 2025 --> Aug 2024 | Active, not recruiting --> Terminated; Strategic business decision
    Trial completion date • Trial termination • Metastases
    |
    Avastin (bevacizumab) • sasanlimab (PF-06801591)
    13d
    A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer (clinicaltrials.gov)
    P1, N=190, Recruiting, Pfizer | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    sasanlimab (PF-06801591)
    17d
    Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=85, Active, not recruiting, Pfizer | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591) • PF-06940434
    18d
    NKT2152-202: Ph2 Study NKT2152 with Palbociclib & Sasanlimab in Subjects with Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov)
    P2, N=172, Active, not recruiting, NiKang Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Jun 2026 | Trial primary completion date: Jun 2026 --> Jun 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Ibrance (palbociclib) • sasanlimab (PF-06801591) • NKT2152
    2ms
    SASAN-SPARING: Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Fundación de investigación HM
    New P2 trial
    |
    cisplatin • gemcitabine • sasanlimab (PF-06801591)
    2ms
    A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines. (clinicaltrials.gov)
    P1, N=190, Recruiting, Pfizer | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    sasanlimab (PF-06801591)
    2ms
    A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines. (clinicaltrials.gov)
    P1, N=190, Not yet recruiting, Pfizer | Phase classification: P1/2 --> P1
    Phase classification • Metastases
    |
    sasanlimab (PF-06801591)
    2ms
    Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. (PubMed, Ther Adv Med Oncol)
    Administration of sasanlimab at a dose of 600 mg-Q6W subcutaneously may serve as a convenient alternative to 300 mg-Q4W administration. NCT04181788 (ClinicalTrials.gov); 2019-003818-14 (EudraCT).
    PK/PD data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591)
    3ms
    A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer (clinicaltrials.gov)
    P1, N=190, Not yet recruiting, Pfizer
    New P1 trial
    |
    sasanlimab (PF-06801591)
    3ms
    LTbR: A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination (clinicaltrials.gov)
    P1, N=1, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=220 --> 1 | Trial completion date: Feb 2029 --> Aug 2025 | Trial primary completion date: Feb 2028 --> Aug 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • sasanlimab (PF-06801591)
    3ms
    A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines. (clinicaltrials.gov)
    P1/2, N=190, Not yet recruiting, Pfizer
    New P1/2 trial • Metastases
    |
    sasanlimab (PF-06801591)
    4ms
    Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
    P1/2, N=34, Active, not recruiting, Pfizer | Trial completion date: Jun 2024 --> Oct 2024
    Trial completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
    5ms
    CREST: A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=1070, Active, not recruiting, Pfizer | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    sasanlimab (PF-06801591)
    5ms
    LTbR: A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination (clinicaltrials.gov)
    P1, N=220, Recruiting, Pfizer
    New P1 trial • Metastases
    |
    Avastin (bevacizumab) • sasanlimab (PF-06801591)
    7ms
    IMPRINT: Immuno-pet iMaging resPonses administeRed Immune checkpoiNt inhibiTor (clinicaltrials.gov)
    P2/3, N=20, Not yet recruiting, Radboud University Medical Center | Initiation date: Mar 2024 --> Aug 2024
    Trial initiation date • Checkpoint inhibition
    |
    sasanlimab (PF-06801591)
    8ms
    Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=155, Active, not recruiting, Pfizer | Phase classification: P1b/2 --> P1/2
    Phase classification • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • EGFR mutation • BRAF mutation • ALK translocation
    |
    sasanlimab (PF-06801591)
    8ms
    RAD-VACCINE: Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=33, Recruiting, The Methodist Hospital Research Institute | Trial completion date: Feb 2025 --> Aug 2025 | Trial primary completion date: Feb 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    sasanlimab (PF-06801591)
    8ms
    Study of PF-07265807 in Participants With Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=67, Active, not recruiting, Pfizer | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2024 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Inlyta (axitinib) • sasanlimab (PF-06801591) • PF-07265807
    8ms
    PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=18, Terminated, Pfizer | Trial completion date: Jan 2028 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2026 --> Oct 2023; Study terminated based on internal business considerations and was not based on safety reasons
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    sasanlimab (PF-06801591) • PF-07265028
    9ms
    A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, Pfizer
    New P1 trial
    |
    sasanlimab (PF-06801591)
    9ms
    Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors. (clinicaltrials.gov)
    P1, N=78, Terminated, Pfizer | N=130 --> 78 | Trial completion date: Sep 2025 --> Nov 2023 | Recruiting --> Terminated | Trial primary completion date: Sep 2025 --> Nov 2023; Study was terminated due to strategic considerations and not due to safety.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • sasanlimab (PF-06801591) • PF-07062119
    10ms
    KHKi in HFI: Ketohexokinase Inhibition in Hereditary Fructose Intolerance (clinicaltrials.gov)
    P2, N=8, Completed, Maastricht University Medical Center | Recruiting --> Completed
    Trial completion
    |
    sasanlimab (PF-06801591)
    10ms
    IMPRINT: Immuno-pet iMaging resPonses administeRed Immune checkpoiNt inhibiTor (clinicaltrials.gov)
    P2/3, N=20, Not yet recruiting, Radboud University Medical Center
    New P2/3 trial • Checkpoint inhibition
    |
    sasanlimab (PF-06801591)
    10ms
    SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov)
    P1, N=132, Terminated, Seagen Inc. | Trial completion date: Apr 2025 --> Dec 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Dec 2023; Study closed due to portfolio prioritization
    Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Adcetris (brentuximab vedotin) • sasanlimab (PF-06801591) • SEA-TGT
    12ms
    Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
    P1/2, N=34, Active, not recruiting, Pfizer | Phase classification: P1b/2 --> P1/2 | Trial primary completion date: Jun 2024 --> May 2023
    Phase classification • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    BRAF V600E • BRAF V600
    |
    Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
    1year
    PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=240 --> 17
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    sasanlimab (PF-06801591) • PF-07265028
    1year
    SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov)
    P1, N=132, Active, not recruiting, Seagen Inc. | Recruiting --> Active, not recruiting | N=417 --> 132
    Enrollment closed • Enrollment change • Metastases
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Adcetris (brentuximab vedotin) • sasanlimab (PF-06801591) • SEA-TGT
    1year
    Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=195 --> 75 | Trial completion date: Oct 2025 --> Jul 2024 | Trial primary completion date: Oct 2025 --> Jul 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591) • PF-06940434
    1year
    Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC) (clinicaltrials.gov)
    P1/2, N=100, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Ibrance (palbociclib) • sasanlimab (PF-06801591)
    1year
    A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma. (PubMed, ESMO Open)
    Subcutaneous sasanlimab at 300 mg q4w was well tolerated with promising clinical efficacy observed. Phase II and III clinical trials of sasanlimab are ongoing to validate clinical benefit. Subcutaneous sasanlimab may be a potential treatment option for patients with NSCLC or urothelial carcinoma.
    P1/2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • TMB-H • PD-L1 overexpression
    |
    sasanlimab (PF-06801591)
    over1year
    Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=195, Recruiting, Pfizer | N=104 --> 195
    Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591) • PF-06940434
    over1year
    Study of PF-07265807 in Participants With Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=61, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=161 --> 61
    Enrollment closed • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Inlyta (axitinib) • sasanlimab (PF-06801591) • PF-07265807
    over1year
    Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov)
    P2, N=172, Not yet recruiting, NiKang Therapeutics, Inc.
    New P2 trial • Combination therapy • Metastases
    |
    Ibrance (palbociclib) • sasanlimab (PF-06801591) • NKT2152
    over1year
    PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=240, Recruiting, Pfizer | Trial completion date: Jul 2027 --> Dec 2027 | Trial primary completion date: Jan 2026 --> Jun 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591) • PF-07265028
    over1year
    Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=104, Recruiting, Pfizer | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591) • PF-06940434
    over1year
    Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
    P1b/2, N=34, Active, not recruiting, Pfizer | N=24 --> 34
    Enrollment change • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CRP (C-reactive protein)
    |
    PD-L1 expression • BRAF V600E • BRAF V600
    |
    Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
    over1year
    CREST: A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=1068, Active, not recruiting, Pfizer | Trial primary completion date: Jun 2025 --> Jun 2024
    Trial primary completion date • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    sasanlimab (PF-06801591)
    over1year
    Study of PF-07263689 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=13, Terminated, Pfizer | N=10 --> 13 | Active, not recruiting --> Terminated; The study was terminated by the Sponsor due to business decision and not due to any safety concerns with PF-07263689. There are no changes to the risk-benefit for participants who have received PF-07263689 in the study.
    Enrollment change • Trial termination • Combination therapy • Metastases
    |
    IL2 (Interleukin 2)
    |
    sasanlimab (PF-06801591) • PF-07263689
    over1year
    First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). (PubMed, J Immunother Cancer)
    PrCa VBIR overall demonstrated safety signals similar to other ICI combination trials; significant side effects were seen in some patients with BCR. It stimulated antigen-specific immunity across all cohorts and resulted in modest antitumor activity in patients with BCR without using ADT.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    Imjudo (tremelimumab) • sasanlimab (PF-06801591) • PF-06753512
    over1year
    Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
    P1b/2, N=24, Active, not recruiting, Pfizer | Trial completion date: Dec 2025 --> Jun 2024 | Trial primary completion date: Jul 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • BRAF V600E • BRAF V600
    |
    Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
    over1year
    Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=104, Recruiting, Pfizer | Trial completion date: Nov 2023 --> Feb 2025 | Trial primary completion date: Nov 2023 --> Feb 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    sasanlimab (PF-06801591) • PF-06940434