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PolyPEPI1018 · 1 trial · 1 indication
The incidence and severity \[according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (v5.0)\] of all adverse events (AEs), related AEs, all SAEs, and related SAEs
Number and proportion of participants with any clinically significant change in vital signs (i.e., blood pressure, pulse rate, respiratory rate, body temperature) during the vaccine administration or within 60 minutes following administration
| Arm | Type | Description |
|---|---|---|
| PolyPEPI1018 plus Atezolizumab | EXPERIMENTAL | Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection. |
| Name | Type | Description |
|---|---|---|
| PolyPEPI1018 | DRUG | PolyPEPI1018 vaccine contains 6 synthetic peptides emulsified with the adjuvant Montanide™. The peptides were selected to induce T cell responses against 12 dominant epitopes from 7 tumor-specific antigens, which are the most frequently expressed antigens in colorectal cancer. |
| Atezolizumab | DRUG | Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1. |
Inclusion Criteria: 1. Provide written informed consent for the trial. 2. Adults 18 years or older on the day of signing informed consent. 3. Histologically or cytologically confirmed CRC that is metastatic. 4. Primary and/or metastatic tumor(s) that is known to be MSS as determined locally 5. Must...
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PolyPEPI1018 is an investigational small molecule being studied for the treatment of metastatic colorectal cancer. It is currently in Phase 2 clinical development, evaluated in combination with atezolizumab in patients with this condition. The drug is not yet approved and remains under investigation.
PolyPEPI1018 is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and activity in metastatic colorectal cancer.
PolyPEPI1018 is in Phase 2 clinical development. It is being studied in an active, not recruiting clinical trial for metastatic colorectal cancer. The drug is investigational and has not been approved by regulatory authorities.
PolyPEPI1018 is being evaluated in a Phase 2 clinical trial with the identifier NCT05243862, titled 'Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.' The trial is active but not recruiting, with an enrollment of 18 participants in the United States.
PolyPEPI1018 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for metastatic colorectal cancer. The ongoing study is assessing its safety and activity, and regulatory approval has not been granted.