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Nadunolimab · 1 trial · 1 indication
For the Phase 1b portion, Dose-Limiting Toxicities (DLTs) will be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Adverse events are graded on a scale from 1 (mild) to 5 (death related to AE). Permanent discontinuation of study treatment will occur for any severe (Grade 3) drug-related adverse event that recurs or for any life-threatening (Grade 4) event.
For the phase 2 portion, ORR will be assessed based on the definition, as the combined percent of the subjects experiencing a partial response (PR) or a complete response (CR) at anytime within the first year from the initiation of therapy, or until the documented progression of disease or start of a new anti-cancer therapy. Radiographic response will be determined by the RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Nadunolimab and Toripalimab | EXPERIMENTAL | Participants will receive the investigational combination of nadunolimab and toripalimab. Treatment will continue for up to 1 year or until disease progression, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Nadunolimab | DRUG | 5 mg/kg intravenously (IV) every 3 weeks (Q3W) |
| Toripalimab | DRUG | 240 mg IV every 3 weeks (Q3W) |
Inclusion Criteria: * Patients must have a pathologically confirmed diagnosis of non-MSI-H/pMMR CRC. * Patients must have progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan, or are intolerant to standard chemothera...
Nadunolimab is an investigational small molecule being developed for the treatment of metastatic microsatellite stable colorectal carcinoma. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with chemotherapy-refractory disease.
Nadunolimab is a monoclonal antibody, as indicated by its -mab suffix. Its specific molecular target has not been disclosed in available information. The drug is being evaluated for its potential role in combination immunotherapy for metastatic microsatellite stable colorectal cancer.
Nadunolimab is being developed by Coherus Oncology, Inc., a company listed on the stock exchange under the ticker symbol CHRS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic microsatellite stable colorectal carcinoma.
Nadunolimab is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is recruiting patients to evaluate the drug in the treatment of metastatic microsatellite stable colorectal carcinoma.
Nadunolimab is being studied in a Phase 1 clinical trial registered as NCT07281716, titled 'Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC.' This single-arm, open-label trial is recruiting 24 participants in the United States and is not randomized or blinded.
No alternative names for Nadunolimab have been identified in available information. The drug is referred to solely as Nadunolimab in clinical trial registrations and development documentation. It is a distinct investigational agent being developed by Coherus Oncology, Inc.