What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as bevacizumab, pazopanib, and olaparib, have distinct side effect profiles. Bevacizumab can cause hypertension, proteinuria, and increased risk of bleeding and thromboembolic events. Pazopanib is associated with hypertension, diarrhea, and hepatotoxicity. Olaparib often leads to anemia, nausea, fatigue, and anorexia. Antibody-drug conjugates, like the investigational AZD5335, typically cause side effects related to the cytotoxic agents they deliver, including myelosuppression, neuropathy, and infusion-related reactions. These side effects are generally manageable but require careful monitoring.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for ovarian cancer, including bevacizumab, a monoclonal antibody that inhibits angiogenesis by targeting VEGF. Another notable approval is for PARP inhibitors like olaparib, which target DNA repair mechanisms in cancer cells. While specific antibody-drug conjugates (ADCs) like AZD5335 are not mentioned in the provided context, the general approach of using targeted therapies to deliver cytotoxic agents directly to cancer cells is a growing area of interest in ovarian cancer treatment.

What other types of research exist?

Promising novel alternatives to AZD5335 for ovarian cancer patients in 2024 include Mirvetuximab soravtansine, an ADC targeting folate receptor alpha, and Tisotumab vedotin, an ADC targeting tissue factor. Both have shown efficacy in clinical trials for ovarian cancer.

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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

Must not have

For women only - currently pregnant (confirmed with positive pregnancy test), lactating, breastfeeding, or intend to become pregnant during the study period

History of another primary malignancy except for specific conditions

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

No Placebo-Only Group

Summary

This trial is testing a new treatment called AZD5335, which combines an antibody with a cancer-killing drug. It aims to see if this treatment is safe and effective for patients with advanced solid tumors. The antibody helps deliver the drug directly to the cancer cells, potentially reducing harm to healthy cells.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant, breastfeeding, or planning to become pregnant during the study.

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I have had cancer before, but it meets the trial's exceptions.

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I have a heart condition.

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I have or had lung inflammation needing steroids or extra oxygen.

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I have or had spinal cord compression or cancer spread to the lining of my brain.

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I do not have an active infection like TB, hepatitis B or C, or uncontrolled HIV.

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I haven't taken any of the study's listed medications recently.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose of azd5335 or azd5305 until death due to any cause.(approx 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events/serious adverse events

The number of participants with dose limiting toxicity(DLT), as defined in the protocol

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DoR)

Immunogenicity of AZD5335

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Module 4: AZD5335 + Carboplatin +/- BevacizumabExperimental Treatment2 Interventions

AZD5335 + Carboplatin +/- Bevacizumab

Group II: Module 3: AZD5335 + BevacizumabExperimental Treatment1 Intervention

AZD5335 + Bevacizumab

Group III: Module 2: AZD5335 + SaruparibExperimental Treatment2 Interventions

AZD5335 + Saruparib

Group IV: Module 1: AZD5335 MonotherapyExperimental Treatment1 Intervention

AZD5335 Monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Carboplatin

2014

Completed Phase 3

~6120

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ovarian cancer treatments primarily include surgery, chemotherapy, targeted therapy, and maintenance therapy. Chemotherapy often uses platinum-based agents like carboplatin and paclitaxel, which work by damaging the DNA of cancer cells, leading to cell death. Targeted therapies, such as PARP inhibitors (e.g., niraparib, olaparib), exploit specific genetic weaknesses in cancer cells, particularly those with BRCA mutations, to prevent DNA repair and induce cell death. Antibody-drug conjugates (ADCs), like the experimental AZD5335, combine an antibody specific to cancer cell markers with a cytotoxic drug, delivering the drug directly to cancer cells and minimizing damage to healthy cells. This targeted approach is crucial for ovarian cancer patients as it can enhance treatment efficacy while reducing side effects, improving overall outcomes and quality of life.

Molecular Pathways and Targeted Therapies for Malignant Ovarian Germ Cell Tumors and Sex Cord-Stromal Tumors: A Contemporary Review.