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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
RG7827
i
Other names: RG7827, FAP-4-1BBL FP, FAP-4-1BBL, 4-1BB agonist antibody, RO7122290, RO-7122290, RG 7827, RG-7827, RO 7122290
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News alerts, weekly reports and conference planners
Company:
Roche
Drug class:
CD137 agonist, FAP inhibitor
Related drugs:
2d
Cibisatamab and FAP-4-1BBL in microsatellite-stable colorectal cancer: a phase 1b trial. (PubMed, Nat Med)
Patients received cibisatamab with escalating doses of FAP-4-1BBL weekly or every 3 weeks after obinutuzumab pretreatment to mitigate anti-drug antibody formation. These findings demonstrate the feasibility of combining tumor antigen-directed T cell engagement with localized co-stimulation, with evidence of immune activation and preliminary antitumor activity supporting further clinical development. ClinicalTrials.gov identifier: NCT04826003 .
P1 data • Journal • IO biomarker
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CEACAM5 (CEA Cell Adhesion Molecule 5) • IL2RA (Interleukin 2 receptor, alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
7d
Precision modeling of tumor antigen-specific T-cell responses in humanized mice for preclinical assessment of cancer immunotherapies. (PubMed, J Immunother Cancer)
This adaptable and physiologically relevant model provides a platform to dissect the complex interplay between human tumors, immune cells, and immunotherapies and has the potential to significantly improve the translation of preclinical findings to the clinic.
Preclinical • Journal
|
PD-1 (Programmed cell death 1) • CD40 (CD40 Molecule)
|
RG7827
3ms
MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov)
P1/2, N=272, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • Zejula (niraparib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • magrolimab (ONO-7913) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • RG7827
9ms
BP42675: Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1, N=54, Completed, Hoffmann-La Roche | Phase classification: P1/2 --> P1
Phase classification
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CSF2 (Colony stimulating factor 2)
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
10ms
MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov)
P1/2, N=272, Active, not recruiting, Hoffmann-La Roche | Trial completion date: May 2026 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • Zejula (niraparib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • magrolimab (ONO-7913) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • RG7827
1year
4-1BB agonist targeted to fibroblast activation protein α synergizes with radiotherapy to treat murine breast tumor models. (PubMed, J Immunother Cancer)
Increased FAP expression in the TME as a result of radiotherapy can be exploited to target agonist 4-1BB immunotherapy to malignant tumor lesions using an FAP-4-1BBL antibody fusion protein.
Preclinical • Journal • IO biomarker
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • FAP (Fibroblast activation protein, alpha) • IFNAR1 (Interferon (alpha, beta and omega) receptor 1)
|
RG7827
over1year
BP42675: Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=54, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | N=80 --> 54
Trial completion • Enrollment change
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
over1year
MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov)
P1/2, N=272, Active, not recruiting, Hoffmann-La Roche | N=645 --> 272
Enrollment change
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • Zejula (niraparib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • magrolimab (ONO-7913) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • RG7827
over1year
Combining mathematical modeling, in vitro data and clinical target expression to support bispecific antibody binding affinity selection: a case example with FAP-4-1BBL. (PubMed, Front Pharmacol)
In this work, a workflow to select binding affinities for bispecific antibodies that integrates preclinical in vitro data, mathematical modeling and simulation, and knowledge on target expression in the patient population, is provided. The early implementation of this approach can increase the probability of success with cancer immunotherapy in clinical development.
Preclinical • Journal • IO biomarker
|
TNFRSF9 (TNF Receptor Superfamily Member 9) • FAP (Fibroblast activation protein, alpha)
|
RG7827
over1year
MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov)
P1/2, N=645, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> May 2026
Enrollment closed • Trial completion date
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • Zejula (niraparib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • magrolimab (ONO-7913) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • RG7827
2years
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
over2years
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
Enrollment closed
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
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