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    DRUG CLASS:

    IL-2 stimulant

    Related drugs:
    20h
    KEYNOTE-E29: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=462, Recruiting, Asher Biotherapeutics, Inc. | N=262 --> 462 | Trial completion date: Oct 2025 --> May 2027 | Trial primary completion date: Jun 2025 --> Aug 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • AB248
    22h
    Aerosolized Aldesleukin in Treating Patients With Lung Metastases (clinicaltrials.gov)
    P1, N=70, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1 | Trial completion date: Apr 2024 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2026
    Phase classification • Trial completion date • Trial primary completion date
    |
    Proleukin (aldesleukin)
    2d
    Evaluation of a Combinatorial Immunotherapy Regimen That Can Cure Mice Bearing MYCN-Driven High-Risk Neuroblastoma That Resists Current Clinical Therapy. (PubMed, J Clin Med)
    First, we demonstrate that 9464D-GD2 is nonresponsive to a preferred salvage regimen: anti-GD2 with temozolomide and irinotecan. Second, we have previously shown that adding agonist anti-CD40 mAb and CpG to a regimen of radiotherapy, anti-GD2/IL2 immunocytokine and anti-CTLA-4, cured a substantial fraction of mice bearing small 9464D-GD2 tumors; here, we further characterize this regimen by showing that radiotherapy and hu14.18-IL2 are necessary components, while anti-CTLA-4, anti-CD40, or CpG can individually be removed, and CpG and anti-CTLA-4 can be removed together, while maintaining efficacy. We have developed and characterized a regimen that can cure mice of a high-risk neuroblastoma that is refractory to the current clinical regimen for relapsed/refractory disease. Ongoing preclinical work is directed towards ways to potentially translate these findings to a regimen appropriate for clinical testing.
    Preclinical • Journal
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL2 (Interleukin 2)
    |
    MYCN amplification
    |
    temozolomide • irinotecan • lorukafusp alfa (APN301)
    6d
    A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    8d
    Phase II study to determine the anti-tumor activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in esophageal cancer. (PubMed, Clin Cancer Res)
    P2; FAP-IL2v plus atezolizumab demonstrated clinical activity and was tolerable in patients with previously treated esophageal SCC.
    Journal • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Tecentriq (atezolizumab) • simlukafusp alfa (RG7461)
    14d
    A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=85, Active, not recruiting, Cue Biopharma | Trial completion date: Dec 2023 --> May 2025 | Trial primary completion date: Sep 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • CDKN2A expression
    |
    Keytruda (pembrolizumab) • CUE-101
    19d
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    20d
    A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov)
    P1/2, N=14, Terminated, Avenge Bio, Inc | Trial completion date: Aug 2026 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2026 --> Apr 2024; Sponsor Decision to close study
    Trial completion date • Trial termination • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AVB-001
    20d
    Saltikva for Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Salspera LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • Saltikva (attenuated Salmonella typhimurium expressing IL-2)
    20d
    A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease) (clinicaltrials.gov)
    P1, N=61, Terminated, Visterra, Inc. | Trial completion date: Sep 2024 --> Feb 2024 | Recruiting --> Terminated; The study terminated due to internal strategy change due to changes in risk-benefit ratio
    Trial completion date • Trial termination
    22d
    IMMUNOSABR2: IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study (clinicaltrials.gov)
    P2, N=126, Recruiting, Maastricht University Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL2 (Interleukin 2)
    |
    darleukin (L19IL2)
    25d
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    26d
    Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity from a Phase I Study of Simlukafusp Alfa (FAP-IL2v) in Advanced/Metastatic Solid Tumors. (PubMed, Clin Cancer Res)
    FAP-IL2v had a manageable safety profile and showed initial signs of antitumor activity in advanced/metastatic solid tumors.
    P1 data • PK/PD data • Journal • Metastases
    |
    CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    simlukafusp alfa (RG7461)
    28d
    Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027
    Trial completion date • Trial primary completion date • Surgery • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CDKN2A expression
    |
    CUE-101
    29d
    CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=16, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Apr 2024 | Trial primary completion date: Jan 2025 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2) • MLANA (Melan-A)
    |
    BRAF mutation • BRAF V600
    |
    Yervoy (ipilimumab) • cyclophosphamide • Proleukin (aldesleukin)
    1m
    To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects (clinicaltrials.gov)
    P1, N=84, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Sep 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    1m
    A Study of IBI363 in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2, N=120, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1/2 --> P2 | N=20 --> 120
    Phase classification • Enrollment change • Metastases
    1m
    BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=84, Active, not recruiting, BioNTech SE | Trial completion date: Jun 2026 --> May 2024 | Trial primary completion date: Feb 2024 --> May 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BNT151
    1m
    Neoadjuvant L19IL2/L19TNF- Pivotal Study (clinicaltrials.gov)
    P3, N=214, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2023 --> Oct 2024
    Trial primary completion date • Surgery
    |
    BRAF (B-raf proto-oncogene)
    |
    Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
    1m
    Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers (clinicaltrials.gov)
    P1/2, N=150, Active, not recruiting, Transgene | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Bavencio (avelumab) • tipapkinogene sovacivec (TG4001)
    1m
    IL-2 targeted to CD8+ T cells promotes robust effector T cell responses and potent antitumor immunity. (PubMed, Cancer Discov)
    Efficacy was associated with expansion and phenotypic enhancement of tumor-infiltrating CD8+ T cells, including the emergence of a "better effector" population. These data support the potential utility of AB248 in clinical settings.
    Journal
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    AB248
    2ms
    Safety, efficacy, and biological data of T cell-enabling oncolytic adenovirus TILT-123 in advanced solid cancers from the TUNIMO monotherapy phase I trial. (PubMed, Clin Cancer Res)
    TILT-123 was safe and able to produce anti-tumor effects in local and distant lesions in heavily pre-treated patients. Good tolerability of TILT-123 facilitates combination studies, several of which are ongoing (NCT04217473, NCT05271318, NCT05222932, NCT06125197).
    P1 data • Journal • Oncolytic virus • Metastases
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    2ms
    A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205] (clinicaltrials.gov)
    P2, N=14, Active, not recruiting, Sanofi | Trial completion date: Sep 2024 --> Jan 2025
    Trial completion date
    |
    Keytruda (pembrolizumab) • pegenzileukin (SAR444245)
    2ms
    Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=22, Recruiting, TILT Biotherapeutics Ltd. | Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Mar 2024
    Enrollment open • Trial initiation date • Combination therapy • Oncolytic virus • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • igrelimogene litadenorepvec (TILT-123)
    2ms
    FaCIL-2: Low-dose Interleukin-2 in Women With Unexplained Miscarriages (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, Assistance Publique - Hôpitaux de Paris | Trial primary completion date: Feb 2024 --> Jul 2023 | Trial completion date: Feb 2025 --> Apr 2024
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    CD4 expression
    2ms
    A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov)
    P1/2, N=14, Active, not recruiting, Avenge Bio, Inc | Recruiting --> Active, not recruiting | N=44 --> 14
    Enrollment closed • Enrollment change
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AVB-001
    2ms
    Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=136, Recruiting, Aulos Bioscience, Inc. | N=69 --> 136 | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Oct 2024
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Proleukin (aldesleukin) • AU-007
    2ms
    Non-Viral TCR Gene Therapy (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=210 --> 0 | Trial completion date: Dec 2029 --> Mar 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Mar 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • IO biomarker • Gene therapy • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    2ms
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=320, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2023 --> Apr 2025
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    2ms
    TUNINTIL: TNFalpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 During TIL Treatment of Advanced Melanoma (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, TILT Biotherapeutics Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Dec 2023
    Enrollment closed • Trial primary completion date • Oncolytic virus • Metastases
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    2ms
    TUNIMO: TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy (clinicaltrials.gov)
    P1, N=18, Recruiting, TILT Biotherapeutics Ltd. | Trial primary completion date: Dec 2023 --> Sep 2024
    Trial primary completion date • Oncolytic virus
    |
    igrelimogene litadenorepvec (TILT-123)
    2ms
    A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 (clinicaltrials.gov)
    P1, N=30, Completed, Nektar Therapeutics | Phase classification: P1b --> P1
    Phase classification
    |
    bempegaldesleukin (NKTR-214)
    2ms
    AURELIO-03: Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    2ms
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial completion date: Nov 2025 --> Nov 2024 | Trial primary completion date: Nov 2025 --> Aug 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    3ms
    PIVOT IO 011: A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread (clinicaltrials.gov)
    P1, N=30, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • Inlyta (axitinib) • bempegaldesleukin (NKTR-214)
    3ms
    A Study of IBI363 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P2 trial
    3ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    3ms
    A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov)
    P1/2, N=46, Active, not recruiting, Sanofi | N=80 --> 46
    Enrollment change
    |
    Libtayo (cemiplimab-rwlc) • pegenzileukin (SAR444245)
    3ms
    A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203) (clinicaltrials.gov)
    P2, N=138, Active, not recruiting, Sanofi | N=280 --> 138 | Trial completion date: Mar 2024 --> Sep 2024
    Enrollment change • Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
    3ms
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Synthekine | Trial primary completion date: Jun 2024 --> Jun 2026
    Trial primary completion date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • STK-009/SYNCAR-001
    3ms
    ABILITY: A Beta-only IL-2 ImmunoTherapY Study (clinicaltrials.gov)
    P1/2, N=115, Recruiting, Medicenna Therapeutics, Inc. | Trial primary completion date: Sep 2024 --> Jun 2026
    Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    Keytruda (pembrolizumab) • MDNA11
    3ms
    A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Sanofi | N=120 --> 59 | Trial completion date: Aug 2024 --> Feb 2025
    Enrollment change • Trial completion date
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)