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A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-10-18
Primary completion: 2025-12-30
Study completion finish: 2025-12-30
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05123482
Intervention or treatment
DRUG: AZD8205
DRUG: AZD8205 and AZD2936 (Rilvegostomig)
Conditions
- • Breast Cancer
- • Ovarian Cancer
- • Endometrial Cancer
- • Biliary Tract Carcinoma
Find a site
Closest Location:
Research Site
Research sites nearby
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Research Site
Clayton, Not Specified, Australia
Research Site
South Brisbane, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Sub-Study 1 AZD8205 Monotherapy
| DRUG: AZD8205
|
EXPERIMENTAL: Sub Study 2: AZD8205 in combination with rilvegostomig
| DRUG: AZD8205 and AZD2936 (Rilvegostomig)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
The number of patients with adverse events | Number of patients with adverse events by system organ class and preferred term | 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 | 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. | 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. | From time of informed consent to 30 days post last dose (approximately 1 year) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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). | From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years ) |
Duration of response (DoR) | The time from the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression. | 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. | 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). | 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. | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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 AZD2936 Pharmacodynamics | To assess the change in intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered in combination with rilvegostomig. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) |
Frequently Asked Questions
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