Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-09

Study Completion Date

2020-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors

NCT01577745

Solid Tumors

COMPLETED PHASE1

A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies

NCT02013804

Advanced Malignancies

COMPLETED PHASE1

A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors

NCT03530397

Selected Advanced Solid Tumors

ACTIVE_NOT_RECRUITING PHASE1

A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma

NCT04970992

Solid Tumor Lymphoma

COMPLETED PHASE1

A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors

NCT02829099

Advanced Solid Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MEDI9090

Group Type EXPERIMENTAL

MEDI9090

Intervention Type BIOLOGICAL

MEDI9090 will be administered by IV infusion

Durvalumab

Intervention Type BIOLOGICAL

Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MEDI9090

MEDI9090 will be administered by IV infusion

Intervention Type BIOLOGICAL

Durvalumab

Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects
* 18 years and older
* Must have histologic documentation of advanced solid tumors
* Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option

Exclusion Criteria

* Concurrent enrollment in another clinical study
* Prior participation in clinical studies that include durvalumab alone or in combination
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No