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    DRUG:

    PRT3789

    i
    Other names: PRT3789, PRT-SCA2, PRT-3789, PRT 3789
    Company:
    Prelude Therap
    Drug class:
    SMARCA2 degrader
    Related drugs:
    2ms
    PRT3789-01: PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation (clinicaltrials.gov)
    P1, N=135, Completed, Prelude Therapeutics | Active, not recruiting --> Completed | Trial completion date: Mar 2026 --> Oct 2025 | Trial primary completion date: Mar 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    docetaxel • PRT3789
    2ms
    PRT3789 is a First-in-Human SMARCA2-Selective Degrader that Induces Synthetic Lethality in SMARCA4-Mutated Cancers. (PubMed, Cancer Res)
    Together, these findings demonstrate the selective targeting of SMARCA2 and the potential for a favorable therapeutic index with PRT3789. Phase I/II clinical trials with PRT3789 are ongoing in biomarker-selected patients with SMARCA4-mutated solid tumors.
    P1 data • Journal • First-in-human
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
    |
    PRT3789
    3ms
    KEYNOTE-G02: A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, Prelude Therapeutics | Recruiting --> Active, not recruiting | N=60 --> 7
    Enrollment closed • Enrollment change
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4)
    |
    Keytruda (pembrolizumab) • PRT3789
    5ms
    PRT3789-01: PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation (clinicaltrials.gov)
    P1, N=135, Active, not recruiting, Prelude Therapeutics | Recruiting --> Active, not recruiting | N=226 --> 135
    Enrollment closed • Enrollment change
    |
    docetaxel • PRT3789
    10ms
    KEYNOTE-G02: A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov)
    P2, N=60, Recruiting, Prelude Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4)
    |
    Keytruda (pembrolizumab) • PRT3789
    1year
    A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Prelude Therapeutics
    New P2 trial
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4)
    |
    SMARCA4 mutation • SMARCA4 deletion
    |
    Keytruda (pembrolizumab) • PRT3789
    over1year
    PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation (clinicaltrials.gov)
    P1, N=186, Recruiting, Prelude Therapeutics | N=118 --> 186
    Enrollment change • Combination therapy • Metastases
    |
    docetaxel • PRT3789
    almost2years
    PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation (clinicaltrials.gov)
    P1, N=118, Recruiting, Prelude Therapeutics | N=86 --> 118
    Enrollment change • Combination therapy • Metastases
    |
    docetaxel • PRT3789
    over2years
    A phase I study of PRT3789, a potent and selective degrader of SMARCA2 in patients with advanced or metastatic solid tumors and a SMARCA4 mutation (ESMO 2023)
    Secondary endpoints include objective response rate, progression-free survival, duration of response, disease control rate, and PK and PD profiles of PRT3789. The study began enrolling patients in January 2023.
    Clinical • P1 data • Metastases
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
    |
    SMARCA4 mutation
    |
    PRT3789
    almost3years
    A Study of PRT3789 in Participants With Select Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov)
    P1, N=86, Recruiting, Prelude Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
    |
    PRT3789
    3years
    A Study of PRT3789 in Participants With Select Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation (clinicaltrials.gov)
    P1, N=86, Not yet recruiting, Prelude Therapeutics
    New P1 trial • Metastases
    |
    SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
    |
    PRT3789
    over3years
    Preclinical characterization of PRT3789, a potent and selective SMARCA2 targeted degrader (AACR 2022)
    In subcutaneous cell-line derived xenograft (CDX) models of NSCLC, administration of PRT3789 demonstrated significant dose-related inhibition of SMARCA4-deleted NSCLC growth at tolerated doses, but no effect on the growth of SMARCA4 WT cancers. In summary, consistent with our previous validation studies and genomic perturbation analyses, our potent and selective SMARCA2 targeted degrader PRT3789 induces strong synthetic lethality in SMARCA4-deleted cancers in vitro and in vivo.
    Preclinical
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
    |
    SMARCA4 mutation • SMARCA4 deletion
    |
    PRT3789