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
This study is a Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
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 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.
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
Time frame: From time of Informed consent to 30 days post last dose (approximately 1 year).
The number of patients with serious adverse events
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of Informed consent to 30 days post last dose (approximately 1 year)
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
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.
Time frame: From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
The number of patients with changes from baseline laboratory findings, ECGs and vital signs
Description of laboratory findings and vital signs variables over time including change from baseline.
Time frame: From time of informed consent to 30 days post last dose (approximately 1 year)
Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1).
Time frame: From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Duration of response (DoR)
AstraZeneca Clinical Study Information Center
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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 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 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 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.
Research Site
Duarte, California, United States
COMPLETEDResearch Site
Irvine, California, United States
COMPLETEDResearch Site
Santa Monica, California, United States
RECRUITINGResearch Site
Santa Rosa, California, United States
RECRUITINGResearch Site
Shreveport, Louisiana, United States
COMPLETEDResearch Site
Baltimore, Maryland, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
RECRUITINGResearch Site
St Louis, Missouri, United States
RECRUITINGResearch Site
Albuquerque, New Mexico, United States
RECRUITINGResearch Site
Commack, New York, United States
RECRUITING...and 57 more locations
The time from the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression.
Time frame: From the first documented response to confirmed progressive disease or death ( approx. 2 years )
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or cessation of study treatment.
Time frame: From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Disease Control Rate at 12 weeks (DCR-12)
Percentage of patients with confirmed CR or PR or having SD maintained for \>= 11 weeks from first dose (RECIST 1.1).
Time frame: Measured from first dose until progression. For each patient, this is expected to be at 12 weeks
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause.
Time frame: From first dose of AZD8205 to death ( approx. 2 years )
Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max)
Time to maximum observed plasma concentration of the study drug
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Terminal elimination half-life (t 1/2)
Terminal elimination half life.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Immunogenicity of AZD8205.
The number and percentage of participants who develop ADAs.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Sub Study 1: AZD8205 monotherapy Pharmacodynamics
To assess the intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered as a monotherapy.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Sub Study 2: AZD8205 in combination with rilvegostomig Pharmacodynamics
To assess the change in intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered in combination with rilvegostomig.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Sub-study 2: Rilvegostomig Pharmacokinetics when in combination with AZD8205
To characterize the PK serum concentrations and PK parameters of rilvegostomig in combination with AZD8205.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-study 2: Immunogenicity of Rilvegostomig when in combination with AZD8205
The number and percentage of participants who develop ADAs.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 3: Pharmacokinetics of saruparib in combination with AZD8205 with or without rilvegostomig
To characterize the PK plasma concentration and PK parameters of saruparib, including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow, of saruparib when given in combination with AZD8205 with or without rilvegostomig.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-study 3: Pharmacokinetics of rilvegostomig in combination with AZD8205 and saruparib
To characterize the PK serum concentrations and PK parameters (where applicable) of rilvegostomig when given in combination with AZD8205 and saruparib.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 3: Immunogenicity of rilvegostomig in combination with AZD8205 and saruparib
The number and percentage of participants who develop ADAs.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 4: Pharmacokinetics of AZD9574 in combination with AZD8205 with or without rilvegostomig
To characterize the PK plasma concentration and PK parameters of AZD9574, including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow, of AZD9574 when given in combination with AZD8205 with or without rilvegostomig.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-study 4: Pharmacokinetics of rilvegostomig in combination with AZD8205 and AZD9574
To characterize the PK serum concentrations and PK parameters (where applicable) of rilvegostomig when given in combination with AZD8205 and AZD9574.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 4: Immunogenicity of rilvegostomig in combination with AZD8205 and AZD9574
The number and percentage of participants who develop ADAs.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)