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Enzelkitug · 1 trial · 12 indications
| Arm | Type | Description |
|---|---|---|
| Phase Ia: Dose Escalation | EXPERIMENTAL | Participants in successive cohorts will receive escalating doses of enzelkitug, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
| Phase Ia: Expansion | EXPERIMENTAL | Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ia dose escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
| Phase Ib: Dose Escalation | EXPERIMENTAL | Participants in successive cohorts will receive escalating doses of enzelkitug, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
| Phase Ib: Expansion | EXPERIMENTAL | Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ib dose escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Enzelkitug | DRUG | Enzelkitug will be administered as per the schedule specified in the respective arms. |
| Atezolizumab | DRUG | Atezolizumab will be administered as per the schedule specified in the respective arms. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as per the schedule specified in the respective arms. |
Inclusion Criteria: * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) * Histologically confirmed locally advanced, recurrent, or met...
Enzelkitug is an investigational small molecule being developed for the treatment of locally advanced or metastatic solid tumors. It is being studied as a single agent and in combination with a checkpoint inhibitor in participants with various solid tumor types, including NSCLC, HNSCC, melanoma, TNBC, esophageal cancer, gastric cancer, cervical cancer, colorectal cancer, urothelial carcinoma, clear cell RCC, and HCC.
Enzelkitug is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety, pharmacokinetics, and activity of this investigational drug in patients with locally advanced or metastatic solid tumors.
Enzelkitug is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is active but not recruiting participants, with a planned enrollment of 165 patients.
Enzelkitug is being evaluated in a Phase 1 clinical trial with the identifier NCT05581004. This study is assessing the safety, pharmacokinetics, and activity of Enzelkitug as a single agent and in combination with a checkpoint inhibitor in participants with locally advanced or metastatic solid tumors.
No alternative names for Enzelkitug have been identified. It is a distinct investigational small molecule being developed by Roche Holding AG for the treatment of locally advanced or metastatic solid tumors.