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DRUG:

casdozokitug (CHS-388)

i
Other names: CHS-388, SRF388, Casdo, CHS388, CHS 388
Company:
Coherus Oncology
Drug class:
IL-27 inhibitor
3ms
SRF388-201: Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=30, Completed, Coherus Oncology, Inc. | Active, not recruiting --> Completed | N=134 --> 30
Trial completion • Enrollment change
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • casdozokitug (CHS-388)
3ms
KEYNOTE-C16: Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=145, Completed, Coherus Oncology, Inc. | Active, not recruiting --> Completed | N=260 --> 145 | Trial completion date: Aug 2026 --> Jun 2025 | Trial primary completion date: Dec 2025 --> May 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
7ms
KEYNOTE-C16: Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=260, Active, not recruiting, Coherus Biosciences, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
Keytruda (pembrolizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
9ms
SRF388-201: Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=134, Active, not recruiting, Coherus Biosciences, Inc. | Trial completion date: May 2026 --> Jun 2025
Trial completion date
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • casdozokitug (CHS-388)
1year
Enrollment open
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Avastin (bevacizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
over1year
New P2 trial • Combination therapy • Metastases
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Avastin (bevacizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
over1year
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=134, Active, not recruiting, Coherus Biosciences, Inc. | Trial completion date: Mar 2025 --> May 2026 | Trial primary completion date: Mar 2024 --> May 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • casdozokitug (CHS-388)
almost2years
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=134, Active, not recruiting, Coherus Biosciences, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • casdozokitug (CHS-388)
2years
KEYNOTE-C16: Study of CHS-388 (Formerly Know as SRF388) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=260, Recruiting, Coherus Biosciences, Inc. | Trial completion date: May 2024 --> Aug 2026 | Trial primary completion date: May 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
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Keytruda (pembrolizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
2years
Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VEGF pathways with casdozokitug (casdozo, SRF388) in combination with atezolizumab (atezo) and bevacizumab (bev) in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (uHCC). (ASCO-GI 2024)
Clinical Trial Registration Number NCT05359861 Sponsored by Surface Oncology Background: Casdozo is the first in class and only clinical-stage IL-27 targeting antibody, which neutralizes IL-27 in the tumor microenvironment and stimulates antitumor response. Triplet blockade of the IL-27, VEGF, and PD-(L)1 pathways with casdozo/atezo/bev has an acceptable safety profile to date with promising antitumor activity in uHCC that warrants continued exploration. Toxicity was consistent with the known profiles of the agents, with no new safety signals identified. Biomarker analysis to evaluate immune response and associations of IL-27 pathway and clinical outcomes is ongoing.
Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
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IFNG (Interferon, gamma)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
over3years
IL-27 expressed in the tumor microenvironment is correlated with PD-L1 levels and can induce PD-L1 expression on immune and tumor cells (SITC 2022)
Blocking IL-27 activity by SRF388, a first-in-class monoclonal antibody, enhances immune function and demonstrates monotherapy activity in patients with cancer ( NCT04374877 )...IL-27 + cells are found in close proximity to PD-L1 + cells in patient tumors, and IL-27 can regulate levels of PD-L1 expression in immune cells and tumor cell lines, suggesting cross-talk between these molecules to diminish immune activation within the tumor microenvironment. Combined blockade of IL-27 and PD-(L)1 to enhance antitumor immune responses is currently being evaluated in clinical trials.
PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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PD-L1 expression • LAG3 expression • IL2RA expression
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casdozokitug (CHS-388)
over4years
IL-27 signaling drives a type 1 interferon-like gene expression program of immunoregulatory pathways associated with cancer progression (SITC 2021)
A Phase 1 trial of SRF388 (NCT04374877), a first-in-class anti–IL-27 antibody, has demonstrated monotherapy antitumor activity in a patient with non-small cell lung cancer (NSCLC).1 The current study aimed to characterize the immunoregulatory impact of IL-27 signaling by gene expression profiling...Conclusions These studies elucidate the transcriptional networks that are engaged after IL-27 signaling in immune and cancer cells and highlight the parallels with interferon-associated immune regulation. Blockade of IL-27 provides a novel therapeutic strategy to alleviate a gene transcriptional program implicated in immune suppression and checkpoint resistance.
PD(L)-1 Biomarker • IO biomarker
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LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD4 (CD4 Molecule)
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IL2RA expression
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casdozokitug (CHS-388)