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CHS-114 · 2 trials · 3 indications
Evaluation of rate of DLT of CHS-114 as a monotherapy, or in combination with toripalimab
Safety and tolerability of CHS-114 in combination with toripalimab,
Safety and tolerability of CHS-114 in combination with toripalimab
| Arm | Type | Description |
|---|---|---|
| Cohort A - Arm A1: CHS-114 Dose A + Toripalimab | EXPERIMENTAL | Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W). |
| Cohort A - Arm A2: CHS-114 Dose B + Toripalimab | EXPERIMENTAL | Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
| Cohort B - Arm B1: CHS-114 Dose A + Toripalimab | EXPERIMENTAL | Participants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
| Cohort B - Arm B2: CHS-114 Dose B + Toripalimab | EXPERIMENTAL | Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
| Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + Cisplatin | EXPERIMENTAL | Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W. |
| Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + Toripalimab | EXPERIMENTAL | Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
| Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + Toripalimab | EXPERIMENTAL | Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
| Arm 1a: CHS-114 Dose Escalation | EXPERIMENTAL | Arm 1 monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of CHS-114 as monotherapy in up to 25 participants with advanced solid tumors, to determine the recommended dose for expansion (RDE). |
| Arm 1b: CHS-114 Dose Expansion | EXPERIMENTAL | Arm 1b monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 monotherapy at 2 dose levels (potential recommended dose for expansion RDE in up to 5 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC). |
| Arm 2: CHS-114 + toripalimab Dose Escalation | EXPERIMENTAL | Arm 2 dose escalation will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 RDE levels in up to 6 participants in each dose level with HNSCC. |
| Arm 3: CHS-114 + toripalimab Dose Expansion | EXPERIMENTAL | Arm 3 dose expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 RDE levels in up to 20 participants in each dose level with HNSCC. |
| Name | Type | Description |
|---|---|---|
| CHS-114 | DRUG | Solution for infusion |
| Toripalimab | DRUG | Solution for infusion |
| 5 Fluorouracil | DRUG | Solution for infusion |
| Cisplatin | DRUG | Solution for infusion |
Key Inclusion Criteria: * At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator. * Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CHS-114 is an investigational small molecule being studied for the treatment of advanced solid tumors and metastatic solid tumors, including head and neck squamous cell carcinoma. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
CHS-114 targets CCR8, a protein involved in immune regulation within the tumor microenvironment. By targeting CCR8, CHS-114 is being evaluated as a potential therapy for advanced solid tumors, though its exact mechanism of action is still under investigation in clinical trials.
CHS-114 is being developed by Coherus Oncology, Inc., a subsidiary of Coherus BioSciences (NASDAQ: CHRS). The company is conducting Phase 1 clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
CHS-114 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials are currently listed as active, with one actively recruiting participants and the other no longer recruiting.
CHS-114 is being studied in two Phase 1 trials. NCT05635643 evaluates CHS-114 alone in advanced solid tumors and head and neck squamous cell carcinoma. NCT06657144 studies CHS-114 (also known as Tagmokitug) in combination with toripalimab and/or other treatments in advanced or metastatic solid tumors.
Yes, CHS-114 is also known as Tagmokitug. In clinical trial NCT06657144, the drug is referred to as CHS-114 (Tagmokitug), confirming that these names refer to the same investigational small molecule being developed for advanced solid tumors.