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Antisense Oligonucleotide

AZD9150 + Durvalumab and Chemotherapy 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
Patients must provide informed consent for the genetic sampling and analyses for inclusion in the optional pharmacogenetic research
Part A of the study will include patients that have histological confirmation of a solid malignancy [other than Hepatocellular Carcinoma (HCC)] that is refractory to standard therapy or for which no standard of care regimen currently exists
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (an average of 6 months). dose-limiting toxicities (dlts) will be assessed through 5 weeks for patients who do not receive chemotherapy or 3 weeks for patients receiving chemotherapy.
Awards & highlights

Study Summary

This trial is testing a new drug, AZD9150, to see if it is safe and works well against cancer. The trial will first test AZD9150 alone and then in combination with another drug, durvalumab, or with chemotherapy.

Who is the study for?
Adults over 18 with advanced solid tumors or non-small-cell lung cancer (NSCLC) that standard treatments can't help. They must have a life expectancy of at least 12 weeks, agree to genetic sampling, and meet certain health criteria. Women must not be pregnant and use birth control; men need contraception too. Participants should be fairly active and healthy overall (ECOG score of 0 or 1).Check my eligibility
What is being tested?
The trial is testing AZD9150 in combination with Durvalumab, alone or alongside chemotherapy drugs like Gemcitabine, Nab-paclitaxel, Cisplatin, Carboplatin, and 5-Flourouracil for their safety and effectiveness against advanced solid tumors including NSCLC.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug entering the body, fatigue, nausea or vomiting due to chemotherapy drugs used in combination therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to give a sample for genetic testing and research.
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I have a confirmed solid tumor cancer, not liver cancer, with no effective standard treatment left.
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I am willing to have a biopsy for the study, unless I'm in the first 3 of any arm or in Part D.
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My cancer does not respond to standard treatments anymore.
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I have a tumor that can be measured and has not been treated with radiation.
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I am not pregnant, not breastfeeding, and either use birth control or cannot become pregnant.
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I am a male and either surgically sterile or using contraception during and for 20 weeks after the study.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (an average of 6 months). dose-limiting toxicities (dlts) will be assessed through 5 weeks for patients who do not receive chemotherapy or 3 weeks for patients receiving chemotherapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (an average of 6 months). dose-limiting toxicities (dlts) will be assessed through 5 weeks for patients who do not receive chemotherapy or 3 weeks for patients receiving chemotherapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Maximum Tolerated Dose (MTD) in subjects receiving AZD9150 plus durvalumab and AZD9150 plus durvalumab plus chemotherapy.
Part D: Area under the plasma concentration versus time curve at steady state [AUC(ss)] of AZD9150 administered once per week in combination with durvalumab.
Part D: Minimum plasma concentration at steady state [Ctrough (ss)] of AZD9150 administered once per week in combination with durvalumab.
Secondary outcome measures
Part A: AZD9150 anti-drug antibody titres
Part A: Area under the plasma concentration versus time curve (AUC) of AZD9150 after single-dose.
Part A: Area under the plasma concentration versus time curve [AUC(ss)] at steady state after multiple doses.
+27 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Arm D: AZD9150 SCExperimental Treatment2 Interventions
Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150.
Group II: Arm D: AZD9150 IVExperimental Treatment2 Interventions
Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150.
Group III: Arm A5Experimental Treatment4 Interventions
Patients will receive AZD9150 every two weeks (Q2W) plus durvalumab every three weeks (Q3W) plus carboplatin on Day 1 plus nab-paclitaxel on Days 1, 8, and 15 (every 3 weeks for up to 12-18 weeks). There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
Group IV: Arm A4Experimental Treatment5 Interventions
Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
Group V: Arm A3Experimental Treatment4 Interventions
Depending on the results of Arm A2, Arm A3 may not be conducted. If Arm A3 is conducted, patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + cisplatin on Day 1 + 5-flourouracil (5-FU) over Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
Group VI: Arm A2Experimental Treatment4 Interventions
Patients will receive AZD9150 once weekly (QW) + durvalumab every three weeks (Q3W) + Cisplatin on Day 1 + 5-flourouracil (5-FU) on Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
Group VII: Arm A1Experimental Treatment2 Interventions
Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every four weeks (Q4W). There will be a 1 week AZD9150 lead-in prior to durvalumab dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
AZD9150
2018
Completed Phase 1
~120
Durvalumab
2017
Completed Phase 2
~3870
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,345 Total Patients Enrolled
Melissa Johnson, M.D.Study ChairTennessee Oncology

Media Library

AZD9150 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT03421353 — Phase 1
Solid Tumors Research Study Groups: Arm D: AZD9150 IV, Arm A4, Arm A5, Arm D: AZD9150 SC, Arm A1, Arm A2, Arm A3
Solid Tumors Clinical Trial 2023: AZD9150 Highlights & Side Effects. Trial Name: NCT03421353 — Phase 1
AZD9150 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03421353 — Phase 1

Frequently Asked Questions

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

How hazardous is AZD9150 to patient health?

"Our team has assigned AZD9150 a rating of 1 on the safety scale, as this drug is currently under evaluation in Phase 1 trials and there is only limited data available to support both its efficacy and security."

Answered by AI

What is the current geographic scope of this research endeavor?

"This medical study is actively enrolling participants from 6 sites, including Fairfax, Oklahoma City and Dallas. To reduce hardship for any potential volunteers, it may be best to choose a clinic that's close by."

Answered by AI

Are there currently any opportunities for volunteers to join this experiment?

"Currently, this clinical trial is not open for recruitment. It was initially posted on February 7th 2018 and its last update was November 2nd 2022. If you are seeking other research opportunities, there are 3671 studies searching for cancer patients and 1916 trials requiring AZD9150 participants."

Answered by AI

What ailments is AZD9150 traditionally used to address?

"AZD9150 is a medication utilized to treat metastatic ureter urothelial carcinoma, lymphoma, advanced non-small cell lung cancer and more. It has also been used for initial treatments of certain conditions."

Answered by AI

What are the chief aims of this research?

"The primary outcome of this trial is to assess the minimum plasma concentration at steady state [Ctrough (ss)] of AZD9150 when administered in combination with durvalumab. Blood samples for PK analysis will be collected over a time frame spanning Weeks 0, 1, 5, 6 and 9. Secondary objectives include determining systemic clearance [CL(ss)], area under the plasma concentration versus time curve [AUC(0-inf)], as well as injection site tolerability when compared against intravenous administration QW in conjunction with durvalumab Q4W."

Answered by AI

What prior investigations have there been into the efficacy of AZD9150?

"AZD9150 was initially studied at City of Hope Comprehensive Cancer Centre in 1997. As of now, 2866 trials have been finished and 1916 are still recruiting participants - the majority being conducted out of Fairfax, Virginia."

Answered by AI

Might I be a qualified participant in this experiment?

"This trial is actively seeking 76 individuals with cancer of age 18-130. Those that wish to be considered must meet a strict set of qualifications, including all the inclusion criteria and none of the exclusion parameters."

Answered by AI

Does this experiment accommodate those aged 80 or above?

"This research initiative is recruiting patients that are aged 18 years or older, and no more than 130."

Answered by AI

To what extent is participant recruitment for this experiment progressing?

"This study is no longer welcoming applications. It was originally posted on February 7th 2018 and the last update to its status occurred in November 2nd 2022. Nonetheless, individuals with cancer can still explore 3671 clinical trials currently recruiting participants, as well as 1916 studies enrolling people for AZD9150."

Answered by AI
~11 spots leftby Mar 2025