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    DRUG:

    luveltamab tazevibulin (STRO-002)

    i
    Other names: STRO-002, STRO 002, anti-FolRa ADC STRO-002, luvelta
    Company:
    Sutro Biopharma, Tasly
    Drug class:
    Microtubule inhibitor, Folate receptor 1-targeted antibody-drug conjugate
    Related drugs:
    2ms
    REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1 (clinicaltrials.gov)
    P2/3, N=600, Terminated, Sutro Biopharma, Inc. | Trial completion date: Feb 2028 --> Aug 2025 | Recruiting --> Terminated | Trial primary completion date: Aug 2027 --> Aug 2025; Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta
    Trial completion date • Trial termination • Trial primary completion date • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression • FOLR1 positive
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • luveltamab tazevibulin (STRO-002) • Neulasta (pegfilgrastim)
    3ms
    Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML (clinicaltrials.gov)
    P1/2, N=24, Terminated, Sutro Biopharma, Inc. | Trial completion date: Mar 2029 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Dec 2028 --> Jun 2025; Terminated Early
    Trial completion date • Trial termination • Trial primary completion date
    |
    luveltamab tazevibulin (STRO-002)
    3ms
    STRO-002-GM2: A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer (clinicaltrials.gov)
    P1, N=58, Terminated, Sutro Biopharma, Inc. | Trial completion date: Jan 2026 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2025; Terminated Early
    Trial completion date • Trial termination • Trial primary completion date
    |
    Avastin (bevacizumab) • luveltamab tazevibulin (STRO-002)
    3ms
    REFRaME-L1: Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Sutro Biopharma, Inc. | N=43 --> 0 | Trial completion date: Oct 2026 --> May 2025 | Recruiting --> Withdrawn | Trial primary completion date: Oct 2026 --> May 2025
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    luveltamab tazevibulin (STRO-002)
    7ms
    The anti-FRα antibody-drug conjugate luveltamab tazevibulin demonstrates efficacy in non-small cell lung cancer preclinical models and induces immunogenic cell death. (PubMed, Mol Cancer Ther)
    This improved activity with combination therapy was associated with increased tumoral infiltration of CD8+ T cells. In conclusion, the work presented here provides rationale for evaluating luveltamab tazevibulin in NSCLC either as monotherapy or in combination with immune checkpoint blockade.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8) • FOLR1 ( Folate receptor alpha ) • HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    FOLR1 expression
    |
    luveltamab tazevibulin (STRO-002)
    1year
    The Efficacy and Safety of Folate Receptor α-Targeted Antibody-Drug Conjugate Therapy in Patients With High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers: A Systematic Review and Meta-Analysis. (PubMed, Cancer Med)
    FRα-targeting ADCs, including MIRV, demonstrated definite efficacy and good safety as novel choices for second-line and beyond treatment of advanced or recurrent ovarian cancer. Patients with high FRα expression showed ORR and PFS benefits similar to those in the overall cohort.
    Clinical • Retrospective data • Review • Journal
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    Halaven (eribulin mesylate) • Elahere (mirvetuximab soravtansine-gynx) • luveltamab tazevibulin (STRO-002) • farletuzumab ecteribulin (MORAb-202)
    1year
    Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML (clinicaltrials.gov)
    P1/2, N=24, Recruiting, Sutro Biopharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    luveltamab tazevibulin (STRO-002)
    1year
    STRO-002-GM2: A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer (clinicaltrials.gov)
    P1, N=58, Recruiting, Sutro Biopharma, Inc. | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • luveltamab tazevibulin (STRO-002)
    1year
    Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML (clinicaltrials.gov)
    P1/2, N=24, Not yet recruiting, Sutro Biopharma, Inc.
    New P1/2 trial
    |
    luveltamab tazevibulin (STRO-002)
    over1year
    REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1 (clinicaltrials.gov)
    P2/3, N=600, Recruiting, Sutro Biopharma, Inc. | Trial completion date: Feb 2026 --> Feb 2028 | Trial primary completion date: Sep 2025 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    FOLR1 ( Folate receptor alpha )
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • luveltamab tazevibulin (STRO-002) • Neulasta (pegfilgrastim)
    over1year
    Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=43, Recruiting, Sutro Biopharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    luveltamab tazevibulin (STRO-002)
    over1year
    Phase 2 Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=43, Not yet recruiting, Sutro Biopharma, Inc.
    New P2 trial • Metastases
    |
    luveltamab tazevibulin (STRO-002)