^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    ubamatamab (REGN4018)

    i
    Other names: REGN4018, REGN 4018, REGN-4018
    Company:
    Regeneron, Sanofi
    Drug class:
    CD3 agonist, MUC16 inhibitor
    Related drugs:
    3ms
    A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=300, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial
    |
    ubamatamab (REGN4018) • Kevzara (sarilumab)
    4ms
    R5668-ONC-1938: A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab (clinicaltrials.gov)
    P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2027 --> Nov 2027
    Trial completion date
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab) • REGN5668
    4ms
    Mucin 16-Directed Therapy in Pediatric Sarcomas: Case Evidence of Ubamatamab Efficacy in Epithelioid Sarcoma and Its Implications for Other Sarcoma Subtypes. (PubMed, JCO Precis Oncol)
    MUC16 is frequently detected in ES and MRTs. Ubamatamab is an encouraging anti-MUC16 therapy, demonstrating clinical efficacy. Ongoing trials (ClinicalTrials.gov identifier: NCT06444880) are evaluating ubamatamab in other rare MUC16-positive tumors.
    Retrospective data • Journal
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    ubamatamab (REGN4018)
    4ms
    R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov)
    P1/2, N=890, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jun 2026 --> Jan 2027 | Trial primary completion date: Jun 2026 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • Actemra IV (tocilizumab) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    6ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Platinum resistant
    |
    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    7ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Not yet recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2028 --> Dec 2028 | Trial primary completion date: Apr 2028 --> Dec 2028
    Trial completion date • Trial primary completion date • Platinum resistant
    |
    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    11ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial
    |
    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    12ms
    Translational findings support regimen selection for first-in-human study of ubamatamab (MUC16 × CD3 bispecific antibody) in patients with recurrent ovarian cancer. (PubMed, Clin Transl Sci)
    Integrating preclinical and clinical data determined a target trough concentration range of 5-30 mg/L, which supports evaluation of ubamatamab 250 mg with or without cemiplimab and 800 mg monotherapy once every 3 weeks in expansion cohorts. Preclinical data (cytokine release, tumor regression, monkey PK) had translational value in supporting regimen selection in dose escalation and subsequently in dose expansion after integration with patient data from dose escalation.
    P1 data • Journal
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    MUC16 expression
    |
    Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018)
    1year
    Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies (clinicaltrials.gov)
    P2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018)
    over1year
    Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018)
    over1year
    Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018)
    over1year
    R5668-ONC-1938: A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018 (clinicaltrials.gov)
    P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | N=326 --> 612 | Trial primary completion date: Jan 2027 --> Apr 2027
    Enrollment change • Trial primary completion date • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018) • Kevzara (sarilumab) • REGN5668