Approval Probability
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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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CHS-114 is an investigational small molecule being developed for the treatment of advanced solid tumors and metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with conditions such as head and neck squamous cell carcinoma.
CHS-114 targets CCR8, a protein involved in immune regulation. By targeting CCR8, the drug aims to modulate the tumor microenvironment, potentially enhancing the body's immune response against cancer cells. This mechanism is being evaluated in clinical trials for advanced solid tumors.
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 safety and efficacy of CHS-114 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 the FDA and is still being studied in clinical trials. The ongoing trials are recruiting participants with advanced solid tumors to assess the drug's safety, tolerability, and preliminary efficacy.
CHS-114 is being studied in two Phase 1 clinical trials. NCT05635643 evaluates CHS-114 as a monotherapy in participants with advanced solid tumors, including head and neck squamous cell carcinoma. NCT06657144 studies CHS-114 (also known as tagmokitug) in combination with toripalimab and/or other treatments in participants with advanced or metastatic solid tumors.
Yes, CHS-114 is also known as tagmokitug. This alternative name appears in clinical trial records, where the drug is referred to as CHS-114 (Tagmokitug) in combination studies. Both names refer to the same investigational small molecule targeting CCR8.