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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
ragifilimab (INCAGN1876)
i
Other names: INCAGN1876, INCAGN-1876, INCAGN 1876, INCAGN01876, INCAGN 01876, AGEN1876, CM701, INCAGN-01876
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Company:
Agenus, Incyte
Drug class:
GITR agonist
Related drugs:
4ms
Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma (clinicaltrials.gov)
P2, N=39, Active, not recruiting, University of Pennsylvania | Trial completion date: Jun 2025 --> Apr 2029
Trial completion date
|
MGMT (6-O-methylguanine-DNA methyltransferase) • TERT (Telomerase Reverse Transcriptase)
|
EGFR amplification • IDH wild-type
|
Zynyz (retifanlimab-dlwr) • ragifilimab (INCAGN1876)
5ms
First-in-Human Phase 1/2 Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. (PubMed, Clin Cancer Res)
INCAGN01876 was generally well tolerated; fatigue was the most frequent TRAE. INCAGN01876 elicited transient and variable Treg depletion and limited antitumor activity. Future studies will explore combinatorial approaches.
P1/2 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
TNFA (Tumor Necrosis Factor-Alpha)
|
Keytruda (pembrolizumab) • glembatumumab vedotin (CDX-011) • ragifilimab (INCAGN1876)
over1year
Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC (clinicaltrials.gov)
P1, N=56, Recruiting, Providence Health & Services | Active, not recruiting --> Recruiting | Trial completion date: Jul 2024 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2025
Enrollment open • Trial completion date • Trial primary completion date • Checkpoint inhibition • Metastases
|
CD4 (CD4 Molecule)
|
Zynyz (retifanlimab-dlwr) • DPV-001 • ragifilimab (INCAGN1876)
2years
UPSTREAM: Biomarker-based Study in R/M SCCHN (clinicaltrials.gov)
P2, N=340, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Recruiting --> Active, not recruiting
Enrollment closed • IO biomarker • Metastases
|
Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • Imfinzi (durvalumab) • paclitaxel • docetaxel • Zejula (niraparib) • monalizumab (IPH2201) • ragifilimab (INCAGN1876)
over2years
Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC (clinicaltrials.gov)
P1, N=56, Active, not recruiting, Providence Health & Services | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition • Metastases
|
CD4 (CD4 Molecule)
|
Zynyz (retifanlimab-dlwr) • DPV-001 • ragifilimab (INCAGN1876)
over2years
INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=0, Withdrawn, Incyte Biosciences International Sàrl | N=47 --> 0 | Recruiting --> Withdrawn
Enrollment change • Trial withdrawal • Combination therapy • Metastases
|
Zynyz (retifanlimab-dlwr) • ragifilimab (INCAGN1876)
over3years
Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma (clinicaltrials.gov)
P2, N=32, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
|
MGMT (6-O-methylguanine-DNA methyltransferase) • TERT (Telomerase Reverse Transcriptase)
|
EGFR amplification • TERT mutation • IDH wild-type • TERT promoter mutation
|
Zynyz (retifanlimab-dlwr) • ragifilimab (INCAGN1876)
almost4years
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies (clinicaltrials.gov)
P1/2, N=145, Completed, Incyte Biosciences International Sàrl | Active, not recruiting --> Completed
Trial completion • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ragifilimab (INCAGN1876)
almost4years
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies (clinicaltrials.gov)
P1/2, N=145, Active, not recruiting, Incyte Biosciences International Sàrl | Trial completion date: Sep 2021 --> Jan 2022
Trial completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ragifilimab (INCAGN1876)
over4years
Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC (clinicaltrials.gov)
P1, N=56, Recruiting, Providence Health & Services | Not yet recruiting --> Recruiting
Enrollment open • Checkpoint inhibition
|
CD4 (CD4 Molecule)
|
Zynyz (retifanlimab-dlwr) • DPV-001 • ragifilimab (INCAGN1876)
over4years
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies (clinicaltrials.gov)
P1/2, N=145, Active, not recruiting, Incyte Biosciences International Sàrl | N=45 --> 145 | Trial primary completion date: Apr 2021 --> Sep 2021
Clinical • Enrollment change • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ragifilimab (INCAGN1876)
over5years
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies (clinicaltrials.gov)
P1/2, N=45, Active, not recruiting, Incyte Biosciences International Sàrl | Recruiting --> Active, not recruiting | N=285 --> 45
Clinical • Enrollment closed • Enrollment change • Combination therapy
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ragifilimab (INCAGN1876)
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