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    DRUG:

    TIDAL-01

    i
    Other names: TIDAL-01, TBio-4101
    Associations

    News

    Trials
    Company:
    Xoma
    Drug class:
    Immunostimulant
    Related drugs:
    Associations

    News

    Trials
    2ms
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Aug 2026 --> Apr 2025
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    2ms
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial primary completion date • First-in-human
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    9ms
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | N=15 --> 7 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    10ms
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=25 --> 17
    Enrollment closed • Enrollment change
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    1year
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: May 2026 --> Aug 2026 | Trial primary completion date: May 2026 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    1year
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=31, Terminated, Turnstone Biologics, Corp. | Recruiting --> Terminated | N=60 --> 31 | Trial completion date: Jun 2025 --> Feb 2025; Sponsor decision
    Enrollment change • Trial completion date • Trial termination
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • fludarabine IV • TIDAL-01
    1year
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    2years
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    2years
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jan 2024 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    2years
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    over2years
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Turnstone Biologics, Corp. | Phase classification: P1b --> P1
    Phase classification
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • TIDAL-01
    over2years
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b, N=60, Recruiting, Turnstone Biologics, Corp. | N=30 --> 60
    Enrollment change • Tumor mutational burden • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • TIDAL-01