Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Casdozokitug, SRF388
CHS-388 · 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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CHS-388 is an investigational small molecule developed by Coherus Oncology, Inc. for advanced solid tumors. It was studied in a Phase 1 trial that has completed. It is not described as approved, so it remains an investigational agent in clinical development.
CHS-388 was studied in adults with advanced solid tumors, including clear cell renal cell carcinoma, hepatocellular carcinoma, and non-small cell lung cancer. The Phase 1 study enrolled 145 patients across the United States, Singapore, and South Korea. It is investigational and not approved for any indication.
CHS-388 targets IL-27, a protein. IL-27 is a cytokine in the IL-12 family that has been studied for its role in immune regulation within the tumor microenvironment. CHS-388 is a small molecule designed to bind this target, though its precise clinical effect in patients has not been established.
Coherus Oncology, Inc. is developing CHS-388. The company trades on the Nasdaq under the ticker CHRS. Coherus Oncology sponsored the Phase 1 study of CHS-388 in advanced solid tumors, which is the only registered trial for this asset.
CHS-388 is in Phase 1. Its single registered trial, NCT04374877, was a Phase 1 study in advanced solid tumors that has completed. The study enrolled 145 patients and was controlled, though it was not randomized or double blinded. CHS-388 is not described as approved.
CHS-388 has been studied in one clinical trial, NCT04374877, titled Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors. It was a completed Phase 1 trial with 145 participants, conducted in the United States, Singapore, and South Korea. No active trials are registered.
Yes. CHS-388 was formerly known as SRF388, and the two names refer to the same investigational molecule. The Phase 1 trial NCT04374877 lists both names in its title, confirming the change. Searches for SRF388 should therefore lead to the same asset now called CHS-388.