Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04374877 | Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 145 | — | — | Apr 22, 2020 | Jun 5, 2025 | Nov 10, 2025 | 23 | United States, Singapore +1 |
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
| Toripalimab | DRUG | Toripalimab by IV infusion |
Part A and Part B Abbreviated Inclusion Criteria: * ≥ 18 years of age * Locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy, and for whom no available therapies are appropriate (based on investigator judgment) * Patients in Part B with advanced...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |