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AZD8701 + Durvalumab for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must provide a new or previous tumour sample

Body weight > 35 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)

Awards & highlights

Study Summary

This trial is testing a new drug, AZD8701, to see if it is safe and effective in treating certain types of solid tumors. The drug will be tested alone and in combination with another drug, durvalumab.

Who is the study for?

Adults with advanced solid tumors, including various cancers like lung, breast, and melanoma. They must have a tumor sample available, weigh over 35 kg, and have tried standard treatments without success or no options exist. Participants should be in relatively good health (ECOG 0-1), not pregnant or breastfeeding, willing to use contraception if of childbearing potential, and free from significant heart disease or active COVID-19.Check my eligibility

What is being tested?

The trial is testing AZD8701 alone and combined with Durvalumab for safety and effectiveness against certain advanced solid tumors. It will look at how the body processes these drugs (pharmacokinetics/dynamics) as well as their ability to provoke an immune response (immunogenicity) and fight cancer cells.See study design

What are the potential side effects?

Potential side effects may include typical reactions associated with immunotherapy such as fatigue, skin reactions, inflammation of organs like the lungs or intestines (colitis), hormonal gland problems (like thyroid dysfunction), liver issues; however specific side effects for AZD8701 are being studied.

Eligibility Criteria

Inclusion Criteria

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

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You need to provide a recent or past sample of your tumor for the study.

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You weigh more than 35 kilograms.

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You have a disease that is not getting better with usual treatments, or there are no standard treatments available for your disease, and joining a clinical trial is the best choice for your next treatment based on how you have responded to previous treatments.

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You have already received a specific type of treatment for your non-small lung cancer.

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You have not been treated with PD(L)1 medication before for clear cell renal cancer.

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You are able to perform daily activities with little to no help.

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You have a tumor that can be measured by a CT scan or MRI, and it was checked within the last 28 days before starting treatment.

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If you have triple negative breast cancer, you have not had a specific type of treatment before.

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You are expected to live for more than 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of AEs and SAEs related to AZD8701 as monotherapy and in combination with Durvalumab in disease specific expansions treated at the MTD/OBD/MFD

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of Dose Limiting Toxicities (DLTs)

+2 more

Secondary outcome measures

Best percentage change in tumour size according to RECIST 1.1 by investigator assessment

Change in FOXP3 mRNA expression

Disease Control Rate at 16 weeks according to RECIST 1.1 by investigator assessment

+13 more

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471

26%

Asthenia

20%

Anaemia

20%

Constipation

17%

Decreased appetite

16%

Diarrhoea

15%

Nausea

13%

Pruritus

10%

Urinary tract infection

10%

Cough

10%

Fatigue

Vomiting

Dyspnoea

Back pain

Oedema peripheral

Pyrexia

Haematuria

Abdominal pain

Arthralgia

Hypothyroidism

Blood creatinine increased

Weight decreased

Sepsis

Pneumonia

Tumour hyperprogression

General physical health deterioration

Death

Acute kidney injury

Pyelonephritis

Device related infection

Urosepsis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab

Trial Design

2Treatment groups

Experimental Treatment

Group I: MonotherapyExperimental Treatment1 Intervention

Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.

Group II: Combination TherapyExperimental Treatment2 Interventions

Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,726 Total Patients Enrolled

Media Library

AZD8701 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04504669 — Phase 1

Solid Tumors Research Study Groups: Monotherapy, Combination Therapy

Solid Tumors Clinical Trial 2023: AZD8701 Highlights & Side Effects. Trial Name: NCT04504669 — Phase 1

AZD8701 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504669 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a history of research surrounding the efficacy of AZD8701?

"AZD8701 was initially researched in 2010 by the professionals at City of Hope. The drug has been tested in 106 different trials so far, and currently there are 333 ongoing studies that have begun recruiting patients; most notably sites located around Madison, Wisconsin."

Answered by AI

How many healthcare centers are currently executing this experiment?

"At the moment, 11 different medical centres are conducting this clinical trial. While there is a site in Madison, Toronto and Houston, 8 additional sites exist to make travel requirements more manageable for participants."

Answered by AI

To what extent is the patient pool for this trial being expanded?

"Indeed, according to clinicialtrials.gov, this medical research project is actively enrolling patients after being initially published on August 18th 2020. 153 participants are required for completion of the trial and will be recruited from 11 different clinical sites."

Answered by AI

Does this research project accept older adults as participants?

"The eligibility requirements for this clinical trial necessitate that potential participants are at least 18 years of age and no older than 101."

Answered by AI

What risks do individuals face when taking AZD8701?

"As this is an early testing stage (Phase 1), and there is limited clinical data available to verify safety or efficacy, AZD8701 was awarded a score of 1."

Answered by AI

In what contexts is AZD8701 commonly prescribed?

"AZD8701 is mainly used to treat late-stage, inoperable non-small cell lung cancer. It may also be prescribed for patients with metastatic ureteral carcinoma or other advanced directives."

Answered by AI

What key outcomes are being sought in this research project?

"According to the trial's sponsor, AstraZeneca, the primary metric of success will be assessing Maximum Tolerated Dose (or Optimal/Maximum Feasible Dosage) and RP2D of AZD8701 when administered as monotherapy or in combination with Durvalumab. This evaluation period extends from screening until 105 days following the last dose. Secondary objectives include examining Plasma and Urine concentrations of AZD8701 through Non-Compartmental Analysis (NCA), serum concentration levels for Durvalumab when combined with AZD8701, alongside Time To Maximum Concentration values both on their own and"

Answered by AI

Are new participants being sought out for this clinical trial?

"Per clinicaltrials.gov, this investigation is currently recruiting individuals to participate in the research study. The trial opened on August 18th 2020 and was last amended on October 27th 2022."

Answered by AI

What is the eligibility criteria for participation in this research endeavor?

"This clinical trial is recruiting 153 individuals aged 18 to 101 who have been diagnosed with melanoma. To be eligible, patients must weigh more than 35 kilograms and demonstrate an ECOG performance status of 0-1. Furthermore, they ought to possess the capacity to provide informed consent as well as meet other criteria such as not having received prior PD(L)1 treatment (for certain cancers). This study consists of two parts: Monotherapy involving AZD8701 and Combined Therapy with both AZD8701 and Durvalumab being administered. Male and female participants capable of conceiving are required to use effective contraception methods during the duration of the"

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Direct Targeting of FOXP3 in Tregs with AZD8701, a Novel Antisense Oligonucleotide to Relieve Immunosuppression in Cancer

Revenko, Alexey, Larissa S Carnevalli, Charles Sinclair, Ben Johnson, Alison Peter, Molly Taylor, Lisa Hettrick, et al.. 2022. “Direct Targeting of FOXP3 in Tregs with AZD8701, a Novel Antisense Oligonucleotide to Relieve Immunosuppression in Cancer”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2021-003892.

clinicaltrials.govStudy

First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

2020. "First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04504669.

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