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Antibody-drug conjugate
AZD5335 for Cancer (FONTANA Trial)
Phase 1 & 2
Recruiting
Led By Funda Meric-Bernstam, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Participant must be ≥ 18 years at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose of azd5335 or azd5305 until death due to any cause.(approx 2 years)
Awards & highlights
FONTANA Trial Summary
This trial is testing a new anti-cancer treatment to see if it is safe, well-tolerated, and effective against advanced cancer.
Who is the study for?
This trial is for adults with advanced solid tumors who have tried other treatments or consider a clinical trial their best option. They must be able to consent, provide tumor samples, and have an ECOG status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory). Exclusions include patients with certain lung conditions, infections like TB/HIV/HBV/HCV, unresolved toxicities from past therapies, brain metastases requiring steroids, serious heart issues within the last year, pregnancy/breastfeeding intentions during the study period.Check my eligibility
What is being tested?
The study tests AZD5335 alone or combined with other anti-cancer agents in participants with solid tumors. It aims to assess safety and cancer-fighting ability. The phase I/IIa design will first determine safe dosages and then evaluate how well the treatment works.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for similar treatments may include fatigue, nausea, allergic reactions to drug components (like rash), potential organ damage affecting liver/kidney function and blood cell counts leading to increased infection risk.
FONTANA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
FONTANA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first dose of azd5335 or azd5305 until death due to any cause.(approx 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose of azd5335 or azd5305 until death due to any cause.(approx 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events/serious adverse events
The number of participants with dose limiting toxicity(DLT), as defined in the protocol
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Immunogenicity of AZD5335
+16 moreFONTANA Trial Design
2Treatment groups
Experimental Treatment
Group I: Module 2: AZD5335 + AZD5305Experimental Treatment2 Interventions
AZD5335 + AZD5305
Group II: Module 1: AZD5335 MonotherapyExperimental Treatment1 Intervention
AZD5335 Monotherapy
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,553 Total Patients Enrolled
47 Trials studying Ovarian Cancer
23,561 Patients Enrolled for Ovarian Cancer
Funda Meric-Bernstam, MDPrincipal InvestigatorUT MD Anderson Cancer Center
5 Previous Clinical Trials
913 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.Participants must have a disease that can be measured using specific guidelines.You are expected to live for at least 12 weeks.I am fully active or can carry out light work.I am 18 years old or older.I don't have serious side effects from previous treatments, except for stable nerve issues, hair loss, or skin color changes.I am pregnant, breastfeeding, or planning to become pregnant during the study.I need a new biopsy because I've had targeted cancer treatments before.I have had cancer before, but it meets the trial's exceptions.I have a heart condition.I have tried or considered all standard treatments for my advanced cancer, or a trial is my best option.I have given my consent for optional genetic research.I have or had lung inflammation needing steroids or extra oxygen.I have or had spinal cord compression or cancer spread to the lining of my brain.I do not have an active infection like TB, hepatitis B or C, or uncontrolled HIV.I haven't taken any of the study's listed medications recently.My brain metastases are stable, I don't have symptoms, and I haven't needed high-dose steroids recently.I had hepatitis B or C, but it's now resolved or treated.I had radiation pneumonitis, but it's resolved without needing steroids.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Module 2: AZD5335 + AZD5305
- Group 2: Module 1: AZD5335 Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many localities is this experiment currently being conducted in?
"Currently, 7 medical sites across the United States are enrolling patients into this clinical trial. La Jolla, Louisville and Boston all have participating locations in addition to 4 other cities. For those interested in joining the study it is advised that they select a proximate site so as to minimise travel requirements."
Answered by AI
Is this trial recruiting participants currently?
"According to clinicaltrials.gov, this particular research effort is not presently recruiting new patients; the trial was first posted on May 10th 2023 and it's last update took place on March 21st of the same year. Nevertheless, there are 1410 other studies that require volunteers at present."
Answered by AI
Does this clinical trial encompass adults in their forties?
"This research project has a minimum age of 18 and an upper limit of 130 for participants."
Answered by AI
Who is eligible to partake in this trial?
"This study requires that potential participants possess lung adenocarcinoma and are between 18 and 130 years old. The team is aiming to enrol 150 individuals in total."
Answered by AI
What is the primary objective of this clinical investigation?
"This clinical trial's primary aim is to measure the rate of dose-limiting toxicity (DLT) among participants. Secondary objectives involve gauging Objective Response Rate (ORR), Duration of Response (DoR), and Progression-free Survival (PFS). Data for these parameters will be collected from Informed Consent up until 30 days post last dosing administration, with progression or death dates used as censoring events in any PFS analysis."
Answered by AI
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