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    DRUG CLASS:

    CTLA4 antagonist

    Related drugs:
    5d
    SHR-8068-301: Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=560, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab) • Ariely (adebrelimab) • SHR-8068
    21d
    KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
    P1, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1
    Enrollment open • Phase classification • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    1m
    Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer (clinicaltrials.gov)
    P1/2, N=79, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    carboplatin • Imfinzi (durvalumab) • paclitaxel • Imjudo (tremelimumab)
    2ms
    Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=560, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab) • Ariely (adebrelimab) • SHR-8068
    2ms
    Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients with Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=63 --> 28
    Enrollment closed • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, University of Southern California | Trial completion date: Jul 2027 --> Oct 2027 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2026 --> Oct 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    C-800-01: Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer (clinicaltrials.gov)
    P1, N=550, Recruiting, Agenus Inc.
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, City of Hope Medical Center
    New P2 trial • Metastases
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    CIME: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas (clinicaltrials.gov)
    P3, N=124, Not yet recruiting, Centre Leon Berard | Initiation date: May 2024 --> Oct 2024
    Trial initiation date • Checkpoint inhibition • Tumor mutational burden • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG (clinicaltrials.gov)
    P1, N=36, Recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    3ms
    Case report of fatal immune-mediated myocarditis following treatment with davoceticept (ALPN-202), a PD-L1-dependent CD28 costimulator and dual PD-L1/CTLA-4 checkpoint inhibitor, in combination with pembrolizumab. (PubMed, J Immunother Cancer)
    Cardiac autopsy from one patient confirmed immune-related myocarditis, and immunosequencing revealed expansion of a single T-cell clone that was not present in the pretreatment tumor. These cases highlight the importance of understanding risk factors that may contribute to immune-related myocarditis and other severe immune-related adverse events when CD28 agonism is targeted in the context of checkpoint inhibition.NEON-2 (NCT04920383).
    Journal • Combination therapy • Checkpoint inhibition
    |
    CD80 (CD80 Molecule)
    |
    Keytruda (pembrolizumab) • davoceticept (ALPN-202)
    3ms
    FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=86, Recruiting, City of Hope Medical Center | Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    POLE (DNA Polymerase Epsilon)
    |
    Avastin (bevacizumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    4ms
    Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, Hatim Husain | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • oxaliplatin
    4ms
    Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy (clinicaltrials.gov)
    P1/2, N=63, Recruiting, City of Hope Medical Center | Trial completion date: Nov 2024 --> Oct 2025 | Trial primary completion date: Nov 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    4ms
    Phase I studies of davoceticept (ALPN-202), a PD-L1-dependent CD28 co-stimulator and dual PD-L1/CTLA-4 inhibitor, as monotherapy and in combination with pembrolizumab in advanced solid tumors (NEON-1 and NEON-2). (PubMed, J Immunother Cancer)
    Davoceticept was generally well tolerated as monotherapy at intravenous doses up to 10 mg/kg. Evidence of clinical activity was observed with davoceticept monotherapy and davoceticept in combination with pembrolizumab, notably in RCC. However, two fatal cardiac events occurred with the combination of low-dose davoceticept and pembrolizumab. Future clinical investigation with davoceticept should not consider combination with programmed death-1-inhibitor anticancer mechanisms, until its safety profile is more fully elucidated.
    P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD80 (CD80 Molecule)
    |
    Keytruda (pembrolizumab) • davoceticept (ALPN-202)
    4ms
    TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment. (PubMed, J Immunother Cancer)
    TG6050 effectively delivers functional IL-12 and @CTLA-4 into the tumor, resulting in strong antitumor activity. The shift towards an inflamed TME correlated with a boost in systemic antitumor T cells. The solid preclinical data and favorable benefit/risk ratio paved the way for the clinical evaluation of TG6050 in metastatic non-small cell lung cancer (NCT05788926 trial in progress).
    Journal • Oncolytic virus • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    TG6050
    4ms
    Fc-enhanced anti-CTLA-4, anti-PD-1, doxorubicin, and ultrasound-mediated BBB opening: A novel combinatorial immunotherapy regimen for gliomas. (PubMed, Neuro Oncol)
    Our findings demonstrate that FcE-aCTLA-4 promotes robust immunomodulatory and anti-tumor effects in murine gliomas and is significantly enhanced when combined with anti-PD-1, doxorubicin, and LIPU/MB. We are currently investigating this combinatory strategy in a clinical trial (clinicaltrials.gov NCT05864534).
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    doxorubicin hydrochloride • botensilimab (AGEN1181)
    5ms
    Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial. (PubMed, Nat Med)
    The combination of BOT plus BAL demonstrated a manageable safety profile with no new immune-mediated safety signals and encouraging clinical activity with durable responses. ClinicalTrials.gov identifier: NCT03860272 .
    P1 data • Journal • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    5ms
    KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase classification: P1 --> P2
    Phase classification • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    6ms
    NCI-2018-01189: Durvalumab and Tremelimumab Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Stage II-III Breast Cancer (clinicaltrials.gov)
    P1, N=16, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed
    Trial completion • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)
    6ms
    Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) (clinicaltrials.gov)
    P2, N=45, Recruiting, Immune Oncology Research Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6ms
    Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, University of Southern California | Trial completion date: Apr 2027 --> Jul 2027 | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Apr 2026 --> Jul 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6ms
    KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P1 trial • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    7ms
    Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | N=98 --> 22
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • AGEN1571
    7ms
    A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=60, Recruiting, UroGen Pharma Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    gemcitabine • zalifrelimab (UGN-301) • Vesimune (imiquimod intravesical)
    7ms
    NEST-1: Combination Immunotherapy in Colorectal Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, Weill Medical College of Cornell University | Active, not recruiting --> Recruiting | N=12 --> 36 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> May 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    8ms
    AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=4, Terminated, The University of Texas Health Science Center at San Antonio | Active, not recruiting --> Terminated; PI left the institution
    Trial termination • Combination therapy
    |
    cisplatin • gemcitabine • balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    8ms
    Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors (clinicaltrials.gov)
    P2, N=150, Recruiting, Prisma Health-Upstate | Trial completion date: Dec 2026 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Feb 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)
    8ms
    CIME: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas (clinicaltrials.gov)
    P3, N=124, Not yet recruiting, Centre Leon Berard
    New P3 trial
    |
    TMB (Tumor Mutational Burden) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    8ms
    Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=67, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | N=200 --> 67
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    botensilimab (AGEN1181) • AGEN2373
    8ms
    Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, University of Southern California
    New P1 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    8ms
    A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Agenus Inc. | N=177 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    8ms
    Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
    P2, N=24, Recruiting, Weill Medical College of Cornell University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD8 (cluster of differentiation 8)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    8ms
    A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=230, Active, not recruiting, Agenus Inc. | Trial primary completion date: Jan 2024 --> Feb 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    8ms
    Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) (clinicaltrials.gov)
    P2, N=45, Not yet recruiting, Immune Oncology Research Institute
    New P2 trial • Combination therapy
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    8ms
    Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Weill Medical College of Cornell University
    New P2 trial
    |
    CD8 (cluster of differentiation 8)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    9ms
    NEOASIS: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations (clinicaltrials.gov)
    P2/3, N=92, Recruiting, The Netherlands Cancer Institute
    New P2/3 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    9ms
    BBOpCo: Botensilimab and Balstilimab Optimization in Colorectal Cancer (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Nicholas DeVito, MD
    New P2 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    9ms
    A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Anaveon AG | Trial primary completion date: Jun 2024 --> Sep 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600 • BRAF wild-type
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • ANV419
    9ms
    CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=15, Recruiting, Chinese PLA General Hospital | N=10 --> 15
    Enrollment change • Combination therapy • IO biomarker • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    PD-L1 expression • KRAS mutation • MSI-H/dMMR • KRAS G12C • KRAS G12D • KRAS G12V • KRAS G12
    |
    Yervoy (ipilimumab) • albumin-bound paclitaxel • cyclophosphamide • KRAS-EphA-2-CAR-DC
    10ms
    QL1706 (anti-PD-1 IgG4/CTLA-4 antibody) plus chemotherapy with or without bevacizumab in advanced non-small cell lung cancer: a multi-cohort, phase II study. (PubMed, Signal Transduct Target Ther)
    Overall, QL1706 plus chemotherapy, regardless of having bevacizumab, was generally tolerable and had promising antitumor activity for EGFR wild-type advanced NSCLC in first-line setting. Moreover, QL1706 plus chemotherapy and bevacizumab showed favorable antitumor activity for patients who had EGFR mutated NSCLC but failed in TKI therapy, demonstrating a potential for treating this population.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR wild-type
    |
    Avastin (bevacizumab) • Qibeian (iparomlimab/tuvonralimab)
    10ms
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=220, Suspended, Agenus Inc. | Trial completion date: Oct 2023 --> May 2028 | Recruiting --> Suspended | Trial primary completion date: Oct 2023 --> May 2028
    Trial completion date • Trial suspension • Trial primary completion date • Checkpoint inhibition • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)