^
    2ms
    Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
    P1/2, N=258, Recruiting, Sanofi | N=197 --> 258
    Enrollment change • Combination therapy
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
    4ms
    A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=161, Completed, Sanofi | Terminated --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    5ms
    Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of SAR439459, a TGFβ inhibitor, as monotherapy and in combination with cemiplimab in patients with advanced solid tumors: Findings from a phase 1/1b study. (PubMed, Clin Transl Sci)
    SAR'459 monotherapy and combination with cemiplimab appeared relatively safe and tolerable in limited number of patients in dose escalation. However, the study was discontinued due to the unclear efficacy of SAR'459 and bleeding risk, particularly in HCC patients.
    Clinical • P1 data • PK/PD data • Clinical Trial,Phase I • Journal • Combination therapy • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    6ms
    Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
    P1/2, N=197, Recruiting, Sanofi | Trial completion date: Dec 2027 --> Mar 2028 | Trial primary completion date: Dec 2027 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
    9ms
    Biomarker and pharmacodynamic activity of the transforming growth factor-beta (TGFβ) inhibitor SAR439459 as monotherapy and in combination with cemiplimab in a phase I clinical study in patients with advanced solid tumors. (PubMed, Clin Transl Sci)
    SAR439459 ± cemiplimab showed expected peripheral PD effects and TGFβ alteration. However, further studies are needed to identify biomarkers of response.
    P1 data • PK/PD data • Clinical Trial,Phase I • Journal • Combination therapy • PD(L)-1 Biomarker • Metastases
    |
    CXCL10 (Chemokine (C-X-C motif) ligand 10) • TGFB1 (Transforming Growth Factor Beta 1) • TGFB2 (Transforming Growth Factor Beta 2)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    12ms
    Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI) (clinicaltrials.gov)
    P1, N=24, Recruiting, Sanofi | Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Jun 2025
    Phase classification • Trial completion date
    |
    COL1A1 (Collagen Type I Alpha 1 Chain)
    |
    SAR439459
    12ms
    Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
    P1/2, N=197, Recruiting, Sanofi | N=123 --> 197 | Trial completion date: Nov 2028 --> Dec 2027 | Trial primary completion date: Nov 2028 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
    over1year
    SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov)
    P1b, N=3, Terminated, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Dec 2022; The industry supporter discontinued the study and lead drug, SAR439459, due to toxicity.
    Trial completion date • Trial termination • Trial primary completion date • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    over2years
    Safety and efficacy results from the expansion phase of the first-in-human study evaluating TGFβ inhibitor SAR439459 alone and combined with cemiplimab in adults with advanced solid tumors. (ASCO 2022)
    The NCT03192345 study was discontinued due to a lack of efficacy, and a high bleeding risk particularly in pts with HCC.
    Clinical • P1 data
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    over2years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)
    almost3years
    SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov)
    P1b, N=3, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=40 --> 3
    Enrollment closed • Enrollment change • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    3years
    Preliminary biomarker and pharmacodynamic (PD) activity of the TGFβ inhibitor SAR439459, alone or in combination with cemiplimab, in a phase 1 clinical study in patients with advanced solid tumors (SITC 2021)
    Coupled with CD8+ T cell modulation in TME, these findings suggest the identification of early PD biomarkers impacted by SAR439459 which is consistent with the mechanism of action and biological activity of TGFβ blockade therapy. Trial Registration NCT03192345
    Clinical • P1 data • PK/PD data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • TGFB1 (Transforming Growth Factor Beta 1) • FOXP3 (Forkhead Box P3)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    3years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2024 --> Jul 2024
    Clinical • Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)
    over3years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | N=100 --> 280 | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Oct 2021 --> Jul 2024
    Clinical • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)
    over3years
    [VIRTUAL] Pan-TGF-β inhibition with PD-1 blockade as a combination treatment strategy to augment anti-tumor immune response in hepatocellular carcinoma (AACR 2021)
    In addition, we show that combination therapy was associated with increase in the intra-tumoral levels of proinflammatory cytokines - IFNγ, IL-1β, TNF-α as well as enhanced expression of anti-tumor immune related genes. Based on these data, clinical testing of SAR439459 (TGF-β antibody) and Cemiplimab (anti-PD1) combination has recently been initiated in HCC patients (NCT03192345).
    PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • TGFB1 (Transforming Growth Factor Beta 1) • IL1B (Interleukin 1, beta)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    over3years
    SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov)
    P1b, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    almost4years
    SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov)
    P1b, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Libtayo (cemiplimab-rwlc) • SAR439459
    almost4years
    Isatuximab in combination with anti-TGFβ in RRMM Το isatuximab σε συνδυασμό με αντι-TGFβ σε ασθενείς με RRMM (clinicaltrialsregister.eu)
    P1/2, N=60, Ongoing, Sanofi-Aventis Recherche & Developpement
    New P1/2 trial • Combination therapy
    |
    CD38 (CD38 Molecule)
    |
    pomalidomide • Sarclisa (isatuximab-irfc) • SAR439459
    over4years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2; N=100; Recruiting; Sponsor: Hoffmann-La Roche
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)