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AZD5335

AZD5305

AstraZeneca Clinical Study Information Center

Funda Meric-Bernstam, MD

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

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

The study consists of individual modules, each evaluating the safety and tolerability of AZD5335 dosed as monotherapy or in combination with specific treatments.

* Module 1 (AZD5335 monotherapy)
* Module 2 (AZD5335 in combination with AZD5305)

Phase I/IIa Study for AZD5335 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors

FONTANA: A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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.

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)

The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

The time from the date of first response until date of disease progression or death in the absence of disease progression.

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).

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

Area under the plasma concentration-time curve

Maximum observed plasma concentration of the study drug

Time to maximum observed plasma concentration of the study drug

A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.

The pharmacodynamics of AZD5335 by assessing changes in peripheral blood including, but not limited to cytokines, CA-125 and ctDNA.

The number and percentage of participants who develop ADAs.

The clinical activity by baseline and on-treatment changes in tumor target expression.

The plasma concentrations of AZD5335, total antibody, and total unconjugated warhead.

Spots Global Cancer Trial Database for azd5335

Every month we try and update this database with for azd5335 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd5335

Every month we try and update this database with for azd5335 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd5335 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.