A Phase 1 Study of MEDI0562 in Adult Subjects With Selected 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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-02

Study Completion Date

2018-01-09

Brief Summary

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

To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors

Related Clinical Trials

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

A Study in Adult Subjects With Select Advanced Solid Tumors

NCT02583165

Advanced Solid Tumors

COMPLETED PHASE1

Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy

NCT06089967

Cancer Immune-related Adverse Event

COMPLETED

Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer

NCT05620342

Lung Cancer Small Cell Lung Carcinoma Non Small Cell Lung Cancer

RECRUITING EARLY_PHASE1

MIDRIXNEO-LUNG Dendritic Cell Vaccine in Patients With Non-small Cell Lung Cancer

NCT04078269

Non-small Cell Lung Cancer

COMPLETED PHASE1

Dendritic Cell Vaccination for Patients with Solid Tumors

NCT01291420

Glioblastoma Renal Cell Carcinoma Sarcomas +3 more

COMPLETED PHASE1/PHASE2

Detailed Description

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

This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.

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.

Monotherapy Arm

MEDI0562 monotherapy

Group Type EXPERIMENTAL

MEDI0562

Intervention Type BIOLOGICAL

Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.

Interventions

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

MEDI0562

Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

* Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
* Subjects must have at least 1 measurable lesion.
* Consent to provide archived tumor specimens
* Willingness to undergo pre-treatment and on-treatment biopsy.
* Adequate organ function.
* Use of highly effective contraception (females) or male condom plus spermicide (males).

Exclusion Criteria

* Prior treatment with TNFRSF agonists.
* Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.

o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
* History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
* Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
* Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
* Unresolved toxicities from prior anticancer therapy.
* Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No