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    DRUG CLASS:

    Folate receptor 1-targeted antibody-drug conjugate

    Related drugs:
    4d
    TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=1100, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Platinum resistant
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    12d
    A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients (clinicaltrials.gov)
    P1, N=156, Recruiting, Shanghai Institute Of Biological Products | Not yet recruiting --> Recruiting
    Enrollment open
    12d
    RAINFOL-04: Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy (clinicaltrials.gov)
    P3, N=528, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open • Platinum sensitive
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Avastin (bevacizumab) • Rina-S (rinatabart sesutecan)
    12d
    A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Bio-Thera Solutions | N=170 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Platinum resistant
    13d
    BAT-8006-001-CR: Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection (clinicaltrials.gov)
    P1, N=216, Completed, Bio-Thera Solutions | Recruiting --> Completed | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion • Trial primary completion date
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    26d
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=170, Recruiting, Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    28d
    Clinical trial of safety and antitumor activity of farletuzumab ecteribulin in patients with platinum-resistant ovarian cancer: Phase I expansion results. (PubMed, Int J Gynaecol Obstet)
    FZEC showed promising antitumor activity, and the observed adverse events were generally manageable, with the exception of ILD, in patients with PROC.
    P1 data • Journal • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    Halaven (eribulin mesylate) • farletuzumab ecteribulin (MORAb-202)
    29d
    Folate receptor alpha in platinum-resistant ovarian cancer: prevalence in a multicenter Polish cohort and review of the evidence. (PubMed, Clin Transl Oncol)
    Approximately half of the ovarian cancer patients in this multicenter Polish cohort demonstrated FOLR1 positivity. Although this prevalence is lower than that reported in high-grade serous carcinoma cohorts, it likely reflects histological heterogeneity and methodological differences between studies. These findings provide the first population-based evidence from Poland and support the implementation of FOLR1 testing to guide access to mirvetuximab soravtansine. Further research integrating clinical and molecular data is warranted to validate these results and assess implications for cost-effectiveness and patient outcomes.
    Journal • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression • FOLR1 positive
    |
    VENTANA FOLR1 RxDx Assay
    |
    Elahere (mirvetuximab soravtansine-gynx)
    1m
    Folate receptor alpha as a successful biomarker in the treatment of low-grade serous ovarian cancer patients using preclinical and clinical models. (PubMed, Int J Gynecol Cancer)
    FOLR1 is overexpressed in a large percentage of low-grade serous ovarian cancers. Mirvetuximab soravtansine may represent a novel treatment option for low-grade serous ovarian cancer patients progressing after standard treatment modalities. Clinical trials with mirvetuximab soravtansine in FOLR1-positive low-grade serous ovarian cancers are warranted.
    Preclinical • Journal
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression • FOLR1 overexpression • FOLR1 positive
    |
    Elahere (mirvetuximab soravtansine-gynx)
    1m
    RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=240, Not yet recruiting, Genmab
    New P2 trial
    |
    Rina-S (rinatabart sesutecan)
    1m
    RAINFOL-03: Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer (clinicaltrials.gov)
    P3, N=544, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • doxorubicin hydrochloride • Rina-S (rinatabart sesutecan)
    2ms
    RAINFOL-01: Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov)
    P1/2, N=764, Recruiting, Genmab | N=569 --> 764
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    HR positive • HER-2 negative • FOLR1 expression • HR positive + HER-2 negative
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Rina-S (rinatabart sesutecan)