A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD8205: AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial cancers and squamous non-small cell lung cancers.
AZD8205 and AZD2936 (Rilvegostomig): AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial cancers and squamous non-small cell lung cancers. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 and AZD5305 (saruparib): AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. Saruparib is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig): AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. Saruparib is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 in combination with AZD9574: AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. AZD9574 is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936): AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. AZD9574 is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
Study summary
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents
Eligibility
Primary outcome measure(s)
- The number of patients with adverse events — From time of Informed consent to 30 days post last dose (approximately 1 year).
Number of patients with adverse events by system organ class and preferred term - The number of patients with serious adverse events — From time of Informed consent to 30 days post last dose (approximately 1 year)
Number of patients with serious adverse events by system organ class and preferred term - The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. — From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes pre-defined haematological and non-haematological toxicities. - The number of patients with changes from baseline laboratory findings, ECGs and vital signs — From time of informed consent to 30 days post last dose (approximately 1 year)
Description of laboratory findings and vital signs variables over time including change from baseline.
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Duarte | California | Completed |
| Research Site | Irvine | California | Completed |
| Research Site | Santa Monica | California | Recruiting |
| Research Site | Santa Rosa | California | Recruiting |
| Research Site | Shreveport | Louisiana | Completed |
| Research Site | Baltimore | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | St Louis | Missouri | Recruiting |
| Research Site | Albuquerque | New Mexico | Recruiting |
| Research Site | Commack | New York | Recruiting |
| Research Site | New York | New York | Withdrawn |
| Research Site | Charlotte | North Carolina | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Clayton | Australia | Terminated |
| Research Site | Melbourne | Australia | Recruiting |
| Research Site | Nedlands | Australia | Active Not Recruiting |
| Research Site | Anderlecht | Belgium | Recruiting |
| Research Site | Leuven | Belgium | Recruiting |
| Research Site | Calgary | Alberta | Recruiting |
| Research Site | Vancouver | British Columbia | Recruiting |
| Research Site | Ottawa | Ontario | Recruiting |
| Research Site | Toronto | Ontario | Recruiting |
| Research Site | Montreal | Quebec | Completed |
| Research Site | Beijing | China | Completed |
| Research Site | Beijing | China | Recruiting |
| Research Site | Changsha | China | Terminated |
| Research Site | Changsha | China | Recruiting |
| Research Site | Chongqing | China | Recruiting |
| Research Site | Guangzhou | China | Completed |
| Research Site | Kunming | China | Recruiting |
| Research Site | Shandong | China | Recruiting |
| Research Site | Budapest | Hungary | Withdrawn |
| Research Site | Budapest | Hungary | Recruiting |
| Research Site | Budapest | Hungary | Recruiting |
| Research Site | Milan | Italy | Recruiting |
| Research Site | Milan | Italy | Recruiting |
| Research Site | Modena | Italy | Recruiting |
| Research Site | Roma | Italy | Recruiting |
| Research Site | Chūōku | Japan | Recruiting |
+ 27 more sites — see the full list on the official registry below.
More AstraZeneca trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05123482 on ClinicalTrials.gov ↗ ← All trials in Italy