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Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors.
Study details:
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5335 administered either as monotherapy or in combination with other anti-cancer agents in participants with advanced solid malignancies.
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: 2023-06-05
Primary completion: 2028-01-06
Study completion finish: 2028-01-06
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05797168
Intervention or treatment
DRUG: AZD5335
DRUG: Saruparib (AZD5305)
DRUG: Bevacizumab
DRUG: Carboplatin
Conditions
- • Ovarian Cancer
- • Lung Adenocarcinoma
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Liverpool, Not Specified, Australia
Research Site
Melbourne, 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: Module 1: AZD5335 Monotherapy
| DRUG: AZD5335
|
EXPERIMENTAL: Module 2: AZD5335 + Saruparib
| DRUG: AZD5335
|
EXPERIMENTAL: Module 3: AZD5335 + Bevacizumab
| DRUG: Bevacizumab
|
EXPERIMENTAL: Module 4: AZD5335 + Carboplatin +/- Bevacizumab
| DRUG: Bevacizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with adverse events/serious adverse events | Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination. | From time of Informed Consent to 30 days post last dose. |
The number of participants with dose limiting toxicity(DLT), as defined in the protocol | A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol) | From the first dose of AZD5335 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (At the end of 21 days) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective Response Rate (ORR) | The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria. | From time of Informed Consent to progressive disease or withdrawal of consent.(approx 2 years) |
Duration of Response (DoR) | The time from the date of first response until date of disease progression or death in the absence of disease progression. | From the first documented response to confirmed progression or death in the absence of disease progression.(approx 2 years) |
Disease Control Rate (DCR) | The percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 15 weeks after start of treatment (to allow for an early assessment within the assessment window). | From time of Informed Consent until progression.(approx 15 weeks) |
Progression free Survival (PFS) | Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression. Participants who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment | From time of first dose of AZD5335 or AZD5305 until the date of objective disease progression or death (by any cause in the absence of progression).(approx 2 years) |
Overall Survival (OS) | The time until death due to any cause. | From time of first dose of AZD5335 or AZD5305 until death due to any cause.(approx 2 years) |
Module 1: Pharmacokinetics of AZD5335: 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 AZD5335(approximately 12 weeks) |
Module 1: Pharmacokinetics of AZD5335: 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 AZD5335 (approximately 12 weeks) |
Module 1: Pharmacokinetics of AZD5335: 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 AZD5335 (approximately 12 weeks) |
Module 1: Pharmacokinetics of AZD5335: 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 AZD5335 (approximately 12 weeks) |
Module 1: Pharmacokinetics of AZD5335: 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 AZD5335 (approximately 12 weeks) |
Immunogenicity of AZD5335 | The number and percentage of participants who develop ADAs. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD5535.(approx 2 years) |
Module 1: To investigate baseline and on treatment changes in target expression. | The clinical activity by baseline and on-treatment changes in tumor target expression. | Baseline and predicted intervals throughout the administration of AZD5335(approx 2 years) |
Module 2: Pharmacokinetics of AZD5335 and AZD5305 when given in combination. | The plasma concentrations of AZD5335, total antibody, and total unconjugated payload. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD5335 and AZD5305.(approx 12 weeks) |
Module 2, 3, and 4: Area Under the concentration-time curve (AUC) | Area under the plasma concentration-time curve | At predefined intervals throughout the treatment period (approximately 12 weeks) |
Module 2, 3, and 4: Maximum plasma concentration of the study drug (Cmax) | Maximum observed plasma concentration of the study drug | At predefined intervals throughout the treatment period (approximately 12 weeks) |
Module 2, 3, and 4: Time to maximum plasma concentration of the study drug (T-max) | Time to maximum observed plasma concentration of the study drug | At predefined intervals throughout the treatment period (approximately 12 weeks) |
Module 2, 3, and 4: Clearance | A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time. | At predefined intervals throughout the treatment period (approximately 12 weeks) |
Module 2, 3, and 4: 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 AZD5335 (approximately 12 weeks) |
Module 3: Pharmacokinetics of AZD5335 and bevaczizumab when given in combination. | The plasma concentrations of AZD5335, total antibody, and total unconjugated payload. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD5335 and bevacizumab.(approx 12 weeks) |
Module 4: Pharmacokinetics of AZD5335 and carboplatin (+/- bevacizumab) when given in combination. | The plasma concentrations of AZD5335, total antibody, and total unconjugated payload. | From the first dose of study intervention, at predefined intervals throughout the administration of AZD5335 and carboplatin (+/- bevacizumab).(approx 12 weeks) |
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