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Monoclonal Antibodies

Dose-expansion (Pancreatic adenocarcinoma): Oleclumab Dose 4+ Durvalumab Dose 1 for Solid Tumors

Q: What is the usual indication for MEDI9447?

<p>For unresectable stage III non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, MEDI9447 is a suitable remedy. Additionally, this drug can be beneficial for those with advanced metastatic urothelial carcinoma and other medical circumstances that necessitate advance directives.</p>

Phase 1

Waitlist Available

Research Sponsored by MedImmune LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (prior to start of medi9447 infusion and 10 minutes post end of medi4736 infusion), day 57 (prior to start of medi9447 infusion)

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of the combination of two drugs, MEDI9447 and MEDI4736, in treating adult patients with certain types of advanced solid tumors.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (prior to start of medi9447 infusion and 10 minutes post end of medi4736 infusion), day 57 (prior to start of medi9447 infusion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (prior to start of medi9447 infusion and 10 minutes post end of medi4736 infusion), day 57 (prior to start of medi9447 infusion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (prior to start of medi9447 infusion and 10 minutes post end of medi4736 infusion), day 57 (prior to start of medi9447 infusion) for reporting.

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 Abnormal Clinical Laboratory Parameters Reported as TEAEs

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Number of Participants With Change From Baseline in QTcF

+2 more

Secondary outcome measures

Accumulation Ratio for Cmax (Rac Cmax) of MEDI9447

Accumulation Ratio for Ctrough (Rac Ctrough) of MEDI9447

Area Under the Serum Concentration Time Curve From 0 To 14 Days Post First Dose [AUC(0-14)] of MEDI9447

+14 more

Trial Design

11Treatment groups

Experimental Treatment

Group I: Dose-expansion (Pancreatic adenocarcinoma): Oleclumab Dose 4+ Durvalumab Dose 1Experimental Treatment2 Interventions

Participants with previously treated pancreatic adenocarcinoma will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group II: Dose-expansion (NSCLC): Oleclumab Dose 4 + Durvalumab Dose 1Experimental Treatment2 Interventions

Participants with previously treated EGFRm NSCLC will receive oleclumab Dose 4 IV followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group III: Dose-expansion (CRC): Oleclumab Dose 4 + Durvalumab Dose 1Experimental Treatment2 Interventions

Participants with previously treated microsatellite stable-colorectal cancer (MSS-CRC) will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group IV: Dose-escalation: OleclumabDose 4 + Durvalumab Dose 1Experimental Treatment2 Interventions

Participants will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group V: Dose-escalation: OleclumabDose 3 + Durvalumab Dose 1Experimental Treatment2 Interventions

Participants will receive oleclumab Dose 3 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group VI: Dose-escalation: Oleclumab Dose 4Experimental Treatment1 Intervention

Participants will receive oleclumab Dose 4 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group VII: Dose-escalation: Oleclumab Dose 3Experimental Treatment1 Intervention

Participants will receive oleclumab Dose 3 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group VIII: Dose-escalation: Oleclumab Dose 2 + Durvalumab Dose 1Experimental Treatment2 Interventions

Participants will receive oleclumab Dose 2 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group IX: Dose-escalation: Oleclumab Dose 2Experimental Treatment1 Intervention

Participants will receive oleclumab Dose 2 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group X: Dose-escalation: Oleclumab Dose 1 + Durvalumab Dose 1Experimental Treatment2 Interventions

Participants will receive oleclumab Dose 1 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Group XI: Dose-escalation: Oleclumab Dose 1Experimental Treatment1 Intervention

Participants will receive oleclumab Dose 1 intravenously (IV) every two weeks (Q2W) until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Oleclumab

2015

Completed Phase 2

~880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor

347 Previous Clinical Trials

793,717 Total Patients Enrolled

Frequently Asked Questions

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

Has MEDI9447 been explored in prior research?

"MEDI9447 was initially tested at City of Hope in 2010, with 107 trials having been concluded. At present, 333 studies are underway, many originating from Atlanta, Georgia."

Answered by AI

What demographic is most suitable for enrollment in this trial?

"This cancer research study is presently open to participants aged 18-101. To be eligible, they must provide written consent and possess a documented solid tumor including EGFR mutated (EGFRm) NSCLC, 1 measurable lesion based on RECIST guidelines, an ECOG performance score of 0 or 1 and demonstrate adequate organ function. Additionally, archived tissue samples are required for correlative biomarker studies."

Answered by AI

What is the usual indication for MEDI9447?

"For unresectable stage III non-small cell lung cancer, MEDI9447 is a suitable remedy. Additionally, this drug can be beneficial for those with advanced metastatic urothelial carcinoma and other medical circumstances that necessitate advance directives."

Answered by AI

How expansive is the recruitment process for this clinical trial?

"Unfortunately, the study has ended its patient recruitment. It was posted on July 24th 2015 and last updated on November 21st 2022. Nevertheless, currently there are 2585 studies looking for cancer patients and 333 trials searching for participants taking MEDI9447."

Answered by AI

Is this clinical trial accepting new participants?

"As indicated on clinicaltrials.gov, this trial is not pursuing any new patients at present; it was initially posted in July 2015 and last updated November 2022. However, the platform lists 2,918 other trials actively recruiting test subjects right now."

Answered by AI

How many research facilities are conducting the trial?

"Patients may currently join this experiment at 11 different locations, including Atlanta, Durham and Nashville. To limit travel requirements to a minimum, one should strive to select the medical site closest to them when enrolling in the trial."

Answered by AI

Is this research endeavor taking into consideration individuals who are of advanced age?

"The parameters of eligibility specify that the youngest participant can be no younger than 18 and the oldest should not exceed 101 years old."

Answered by AI

Has the FDA sanctioned MEDI9447 for use in clinical settings?

"Since it is a Phase 1 trial, and the safety profile of MEDI9447 has yet to be fully established, our team at Power deemed its risk level as a score of 1."

Answered by AI

Recent research and studies

OncoImmunologyJournal

Targeting CD73 in the Tumor Microenvironment with MEDI9447

Hay, Carl M., Erin Sult, Qihui Huang, Kathy Mulgrew, Stacy R. Fuhrmann, Kelly A. McGlinchey, Scott A. Hammond, et al.. 2016. “Targeting CD73 in the Tumor Microenvironment with MEDI9447”. Oncoimmunology. Informa UK Limited. doi:10.1080/2162402x.2016.1208875.

clinicaltrials.govStudy

MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.

2015. "MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02503774.