^
    10d
    TACTIC: MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (clinicaltrials.gov)
    P2, N=75, Recruiting, Centre Hospitalier Universitaire de Besancon | Not yet recruiting --> Recruiting | Trial completion date: Jun 2029 --> Nov 2029 | Initiation date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2028 --> Nov 2028
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • MP0317
    7ms
    TACTIC: MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (clinicaltrials.gov)
    P2, N=75, Not yet recruiting, Centre Hospitalier Universitaire de Besancon
    New P2 trial
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • MP0317
    almost2years
    MP0317-CP101: First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=46, Terminated, Molecular Partners AG | N=78 --> 46 | Recruiting --> Terminated; After completion of the dose-escalation part of the study, the safety profile of MP0317 in monotherapy is considered adequately characterized in the dose-escalation part of the study.
    Enrollment change • Trial termination • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    MP0317
    over2years
    Potentiating Local and Abscopal Antitumor Efficacy through Radiation with FAP-CD40 DARPin and Anti-PD1 Therapy. (PubMed, Int J Radiat Oncol Biol Phys)
    mFAP-CD40 DARPin with RT and α-PD1 proved efficacious to control primary and secondary tumors in a murine lung carcinoma model with no detected toxicities.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    FAP (Fibroblast activation protein, alpha) • CD40 (CD40 Molecule)
    |
    FAP expression
    |
    MP0317
    over2years
    Ongoing phase 1 study of MP0317, a FAP-CD40 DARPin, shows a favorable safety profile and early evidence of tumor-localized CD40 activation in patients with advanced solid tumors (SITC 2023)
    Analysis of paired tumor biopsies and peripheral biomarkers provided evidence of target occupancy and pharmacodynamic modulation in the TME, consistent with tumor-localized CD40 activation. These data support continued clinical evaluation of MP0317, including combination studies.
    Clinical • P1 data • IO biomarker • Metastases
    |
    IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • FAP (Fibroblast activation protein, alpha) • CD40 (CD40 Molecule)
    |
    FAP expression
    |
    MP0317
    over2years
    Potentiating Local and Abscopal Antitumor Efficacy through Radiation with FAP-CD40 DARPin and Anti-PD1 Therapy (ASTRO 2023)
    Human FAPxCD40 (MP0317) is being evaluated in Phase I trials... mFAP-CD40 DARPin with RT and a-PD1 proved efficacious to control primary and secondary tumors in a murine lung carcinoma model with no detected toxicities.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    FAP (Fibroblast activation protein, alpha) • CD40 (CD40 Molecule)
    |
    FAP expression
    |
    MP0317
    over2years
    Phase I study of MP0317, a FAP-dependent DARPin, for tumor-localized CD40 activation in patients with advanced solid tumors. (ASCO 2023)
    Clinical data and the lack of pro-inflammatory circulating cytokines confirm MP0317 is safe and well-tolerated, while analysis of paired pre- and on-treatment tumor biopsies suggests early evidence of tumor-localized CD40 activation. The current data enables further evaluation in a combination setting. Clinical trial information: NCT05098405.
    Clinical • P1 data • IO biomarker • Metastases
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • IL2 (Interleukin 2) • CCL20 (C-C Motif Chemokine Ligand 20) • CD40 (CD40 Molecule) • CXCR5 (C-X-C Motif Chemokine Receptor 5) • CCR6 (C-C Motif Chemokine Receptor 6) • CXCL3 (C-X-C Motif Chemokine Ligand 3)
    |
    MP0317
    3years
    MP0317-CP101: First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=78, Recruiting, Molecular Partners AG | N=45 --> 78
    Enrollment change • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    MP0317
    3years
    A phase 1 study to characterize the safety and tolerability of MP0317, a tumor targeting FAP dependent CD40 agonist DARPin, in patients with relapsed/refractory solid tumors (SITC 2022)
    All Patients gave written informed consent before taking part in the study. Consent N/A at this point
    Clinical • P1 data • Late-breaking abstract • IO biomarker
    |
    CD40 (CD40 Molecule)
    |
    CD40 expression
    |
    MP0317
    4years
    A phase 1 study to characterize the safety and tolerability of MP0317, a tumor targeting FAP dependent CD40 agonist DARPin®, in patients with relapsed/refractory solid tumors (ESMO-IO 2021)
    Legal entity responsible for the study Molecular Partners AG. Funding Molecular Partners AG.
    Clinical • P1 data • IO biomarker
    |
    CD40 (CD40 Molecule)
    |
    CD40 expression
    |
    MP0317
    4years
    MP0317-CP101: First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=45, Recruiting, Molecular Partners AG
    Clinical • New P1 trial
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    MP0317
    almost5years
    [VIRTUAL] MP0317, a CD40xFAP targeting multi-specific DARPin® therapeutic, drives immune activation and reverts myeloid-mediated T-cell suppression in vitro and ex vivo (AACR 2021)
    TAM-like macrophages potently supressed anti-CD3/28 driven T-cell activation and indeed the addition of MP0317 was found to restore T-cell response. Together these data further support MP0317’s FAP targeted multimodal mechanism of action in human tumors, provide evidence for an improved therapeutic window over existing CD40 agonists and support progression to the clinic with an informed target patient profile.
    Preclinical • IO biomarker
    |
    FAP (Fibroblast activation protein, alpha) • CD40 (CD40 Molecule)
    |
    CD40 expression
    |
    MP0317