Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

MEDI1191 escalation in sequential and concurrent combination with durvalumab

MEDI1191 expansion in concurrent combination with durvalumab

Subjects will receive MEDI1191 (at least twice)

MEDI1191

Subject will receive durvalumab every 4 weeks

MedImmune LCC

To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.

This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral injection in sequential and concurrent combination with intravenous durvalumab to subjects with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of doses.

A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors

A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination With Durvalumab in Subjects With Advanced Solid Tumors

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

The occurrence of DLTs will be used to establish the maximum tolerated dose (MTD) of MEDI1191.

The ORR is defined as the proportion of subjects with confirmed response (CR) or confirmed partial response (PR).

The DCR will be estimated by the proportion of disease control. Disease control is defined as CR, PR or stable disease.

The DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

The TTR is defined as the time from the start of treatment with any investigational product until the first documentation of a subsequently confirmed objective response.

PFS will be measured from the start of treatment with any investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first.

OS will be measured from the start of treatment with investigational product until death due to any cause.

The endpoints for assessment of PK of MEDI1191 and durvalumab include individual MEDI1191 and durvalumab concentrations in serum at different timepoints after administration.

The endpoints for assessment of PK of MEDI1191 include MEDI1191 concentrations in serum at different timepoints after administration.

The endpoints for assessment of immunogenicity of MEDI1191 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).

Spots Global Cancer Trial Database for medi1191

Every month we try and update this database with for medi1191 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for medi1191

Every month we try and update this database with for medi1191 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for medi1191 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.