Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CHS-388
Casdozokitug · 2 trials · 4 indications
Evaluation of DLT of CHS-388 as a monotherapy.
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
Evaluation of DLT of CHS-388 in combination with pembrolizumab.
Safety and tolerability of CHS-388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 5.0 or higher.
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
CR or PR per RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab | EXPERIMENTAL | - |
| Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab | EXPERIMENTAL | - |
| Arm C: Toripalimab + Bevacizumab | ACTIVE_COMPARATOR | - |
| Part A Monotherapy Dose Escalation | EXPERIMENTAL | The Part A monotherapy dose escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of CHS-388 as monotherapy in up to 30 patients with advanced solid tumors. |
| Part B CHS-388 Monotherapy Expansion | EXPERIMENTAL | Part B monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-388 monotherapy at the recommended phase 2 dose (RP2D) in up to 40 patients with ccRCC, up to 40 patients with HCC, and up to 40 patients with NSCLC. |
| Part C CHS-388 in Combination with Pembrolizumab | EXPERIMENTAL | Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab in patients with advanced RCC or HCC, or anti-PD(L)1 relapsed/refractory advanced NSCLC. |
| Part D CHS-388 in Combination with Toripalimab | EXPERIMENTAL | Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab in patients with anti-PD(L)1 relapsed/refractory advanced NSCLC. |
| Name | Type | Description |
|---|---|---|
| Casdozokitug | DRUG | Solution for infusion |
| Toripalimab | DRUG | Solution for infusion |
| Bevacizumab | DRUG | Solution for infusion |
| CHS-388 | DRUG | CHS-388 is a fully human IgG1 antibody against IL-27. Inhibition of IL-27 with CHS-388 reduces STAT1 phosphorylation leading to increased pro-inflammatory (anti-tumor) cytokine secretion (e.g., IFN-g, TNF-a) and decreased expression of inhibitory immune checkpoint receptors (e.g., PD-L1, TIGIT, LAG3) on immune cells that may result in anticancer therapeutic activity. |
| Pembrolizumab | DRUG | Pembrolizumab by intravenous (IV) infusion |
Key Inclusion Criteria: * Unresectable locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic participants. * Disease that is not amenable to curative surgical and/or locoregional ...
Casdozokitug is an investigational small molecule being studied for the treatment of unresectable and/or locally advanced or metastatic Hepatocellular Carcinoma. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Casdozokitug targets IL-27, a cytokine involved in immune regulation. By targeting IL-27, the drug aims to modulate the immune response in the tumor microenvironment, which may be relevant for treating Hepatocellular Carcinoma.
Casdozokitug is being developed by Coherus Oncology, Inc., a subsidiary of Coherus BioSciences, which trades on NASDAQ under the ticker symbol CHRS.
Casdozokitug is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing trial is active but not recruiting participants.
Casdozokitug is being evaluated in a Phase 2 trial (NCT06679985) that combines it with toripalimab plus bevacizumab in participants with unresectable and/or locally advanced or metastatic Hepatocellular Carcinoma. The trial has an enrollment of 72 participants and is active in the United States, Australia, Canada, Hong Kong, Singapore, and Taiwan.
No alternative names for Casdozokitug have been reported. It is identified solely by its generic name in clinical trial registries and company communications.