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    DRUG:

    gotistobart (BNT316)

    i
    Other names: BNT-316, ONC392, BNT316, ONC-392, ONC 392, BNT 316
    Company:
    BioNTech, OncoC4
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    1d
    PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov)
    P3, N=600, Recruiting, OncoC4, Inc. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)
    29d
    PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, OncoC4, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    30d
    PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov)
    P3, N=600, Active, not recruiting, OncoC4, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)
    6ms
    PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov)
    P1/2, N=733, Recruiting, OncoC4, Inc. | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Jun 2024 --> Jun 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • docetaxel • gotistobart (BNT316)
    10ms
    PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov)
    P1/2, N=914, Recruiting, OncoC4, Inc. | Phase classification: P1a/1b --> P1/2 | Trial primary completion date: Dec 2023 --> Jun 2024
    Phase classification • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    12ms
    PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov)
    P1/2, N=144, Recruiting, OncoC4, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • gotistobart (BNT316)
    1year
    PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov)
    P1/2, N=144, Not yet recruiting, OncoC4, Inc. | Phase classification: P2 --> P1/2 | N=90 --> 144 | Trial completion date: Dec 2026 --> Jun 2027 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: Dec 2025 --> Jun 2026
    Phase classification • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • gotistobart (BNT316)
    over1year
    PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, OncoC4, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gotistobart (BNT316) • AI-061
    over1year
    PRESERVE-003: Study of Gotistobart (ONC-392/BNT316) vs. Docetaxel in PD-1 Resistant Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3 | N=600 | Recruiting | Sponsor: OncoC4, Inc. | Not yet recruiting ➔ Recruiting
    Enrollment open
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)
    over1year
    PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, OncoC4, Inc.
    New P1 trial • Metastases
    |
    gotistobart (BNT316)
    almost2years
    PRESERVE-003: Study of ONC-392 vs. Docetaxel in PD-1 Resistant Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=600, Not yet recruiting, OncoC4, Inc.
    New P3 trial • Metastases
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    docetaxel • gotistobart (BNT316)
    almost2years
    PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=58, Recruiting, OncoC4, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    almost2years
    PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, OncoC4, Inc. | Initiation date: Sep 2022 --> Dec 2022
    Trial initiation date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    over2years
    PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, OncoC4, Inc.
    New P2 trial
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)
    almost3years
    PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov)
    P1a/1b, N=413, Recruiting, OncoC4, Inc. | N=300 --> 413 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    EGFR mutation
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • gotistobart (BNT316)
    over3years
    PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov)
    P1a/1b, N=300, Recruiting, OncoC4, Inc. | N=91 --> 300 | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2022 --> Dec 2022
    Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • gotistobart (BNT316)
    over4years
    [VIRTUAL] First-in-human phase I/II clinical trial of ONC-392: Preserving CTLA-4 immune tolerance checkpoint for safer and more effective cancer immunotherapy. (ASCO 2020)
    The trial consists of a dose-finding, dose escalation or de-escalation, Phase IA component aimed at defining the recommended phase II dose for ONC-392 in combination with a standard dose of Pembrolizumab (RP2D-C), then progressing into two parallel, single arm, Phase IB expansion cohorts to test for safety and initial efficacy in two groups of patients with NSCLC: Stage IV NSCLC anti-PD(L)1 immunotherapy naïve with PD-L1-positive (PD-L1 TPS ≥ 1%); Stage IV NSCLC refractory/resistant to anti-PD(L)1 immunotherapy. Research Funding: U.S. National Institutes of Health, Pharmaceutical/Biotech Company
    Clinical • P1/2 data
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Keytruda (pembrolizumab) • gotistobart (BNT316)