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    DRUG:

    tenalisib (RP6530)

    i
    Other names: RP6530, RP-6530, CN401
    Company:
    Curon Biopharma, Rhizen
    Drug class:
    PI3K inhibitor, PI3Kδ inhibitor, PI3Kγ inhibitor, SIK3 inhibitor
    Related drugs:
    2ms
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Recruiting, Rhizen Pharmaceuticals SA | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    tenalisib (RP6530)
    4ms
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Rhizen Pharmaceuticals SA
    New P2 trial • Metastases
    |
    tenalisib (RP6530)
    10ms
    Safety and efficacy of tenalisib in combination with romidepsin in patients with relapsed/refractory T-cell lymphoma: results from a phase I/II open-label multicenter study. (PubMed, Haematologica)
    Coadministration of tenalisib and romidepsin did not significantly alter the pharmacokinetics of romidepsin. Overall, tenalisib and romidepsin combination demonstrated a favorable safety and efficacy profile supporting its further development for relapsed/refractory TCL.
    Clinical • P1/2 data • Journal • Combination therapy
    |
    Istodax (romidepsin) • tenalisib (RP6530)
    12ms
    Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov)
    P1/2, N=17, Completed, Rhizen Pharmaceuticals SA | Trial primary completion date: Mar 2022 --> Mar 2023
    Trial primary completion date
    |
    tenalisib (RP6530)
    12ms
    Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=40, Completed, Rhizen Pharmaceuticals SA | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Dec 2022 --> Mar 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    tenalisib (RP6530)
    over1year
    Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL (clinicaltrials.gov)
    P2, N=0, Withdrawn, Rhizen Pharmaceuticals SA | N=40 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • tenalisib (RP6530)
    over1year
    Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Rhizen Pharmaceuticals SA | Initiation date: May 2022 --> Jan 2023
    Trial initiation date
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • tenalisib (RP6530)
    2years
    Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Rhizen Pharmaceuticals SA
    New P2 trial
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • tenalisib (RP6530)
    over3years
    Phase I/Ib Study of Tenalisib (RP6530), a Dual PI3K δ/γ Inhibitor in Patients with Relapsed/Refractory T-Cell Lymphoma. (PubMed, Cancers (Basel))
    With an acceptable safety and promising clinical activity, Tenalisib can be a potential therapeutic option for relapsed/refractory TCL. Currently, a phase I/II combination study with romidepsin is ongoing.
    Clinical • P1 data • Journal
    |
    TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    Istodax (romidepsin) • tenalisib (RP6530)