Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Durvalumab, Durvalumab (Cohort 1-3), Durvalumab (MEDI4736), durvalumab
durvalumab+ rHu · 1 trial · 1 indication
To characterise the AUC of SC durvalumab.
To characterise the Ctrough of SC durvalumab
| Arm | Type | Description |
|---|---|---|
| Part 1: SC Durvalumab DL1 | EXPERIMENTAL | Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. |
| Part 1: SC Durvalumab DL2 | EXPERIMENTAL | Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. |
| Part 2: Expansion Cohort, SC Durvalumab Dose Level X | EXPERIMENTAL | Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. |
| Name | Type | Description |
|---|---|---|
| SC durvalumab + rHu | DRUG | Durvalumab + rHu will be administered subcutaneously. |
| IV durvalumab | DRUG | Durvalumab will be administered intravenously. |
| Tremelimumab | DRUG | Tremelimumab will be administered to participants with unresectable HCC as an IV infusion. |
Inclusion Criteria: * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of ≥ 12 weeks at enrolment. * Adequate organ and marrow function. * Minimum body weight \> 30 kg. Part 1 only: Locally Advanced Unresectable (Stage III) NSCLC Participants - * Histo...
| 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 |
Durvalumab is an investigational antibody being studied for multiple cancers, including triple negative breast neoplasms, extensive-stage small cell lung cancer, invasive bladder cancer, metastatic non-small cell lung cancer, and non-small cell lung cancer. It is currently in Phase 3 clinical development and is not FDA approved.
Durvalumab is a monoclonal antibody (mab) that targets PD-L1, a protein that helps cancer cells evade the immune system. By blocking PD-L1, durvalumab aims to enhance the body's immune response against tumors. This mechanism is being evaluated across several oncology indications.
Durvalumab is developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting multiple clinical trials to evaluate durvalumab as a potential treatment for various solid tumors.
Durvalumab is in Phase 3 clinical development for extensive-stage small cell lung cancer and other indications. It is an investigational drug, meaning it has not yet received FDA approval. Several Phase 3 trials are ongoing or completed, with a total of 8 clinical trials registered.
Durvalumab is being studied in 8 clinical trials, including NCT03043872 (CASPIAN), a Phase 3 trial combining durvalumab with tremelimumab and chemotherapy in untreated extensive-stage small cell lung cancer. Other trials include NCT03446547, NCT04449861, and NCT04712903, all evaluating durvalumab in lung cancer settings.
Durvalumab is also known as Durvalumab/Tremelimumab Combination Therapy, referring to its use in combination with tremelimumab. It is also referred to as Durvalumab (MEDI4736), Durvalumab + Chemotherapy, and SC durvalumab + rHu. These names describe different regimens or formulations of the same drug.