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Clinical Trial Record

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A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors

2018-12-20

2019-12-10

2019-12-10

8

Study Overview

A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors

To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or metastatic solid tumor malignancies that have received at least 1 prior line of treatment.

N/A

  • Non Small Cell Lung Cancer Squamous (NSCLC-Sq)
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Small Cell Lung Cancer (SCLC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Colorectal Cancer (CRC)
  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • DRUG: MEDI7247
  • D8540C00002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2018-12-21  

N/A  

2019-12-27  

2019-01-17  

N/A  

2019-12-30  

2019-01-22  

N/A  

2019-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: NSCLC-Sq/HNSCC

Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have re

DRUG: MEDI7247

  • Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
EXPERIMENTAL: Small Cell Lung Cancer

Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen.

DRUG: MEDI7247

  • Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
EXPERIMENTAL: Colorectal Cancer

Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irin

DRUG: MEDI7247

  • Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
EXPERIMENTAL: Pancreatic Ductal Adenocarcinoma

Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment.

DRUG: MEDI7247

  • Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
EXPERIMENTAL: Metastatic Castration-Resistant Prostate Cancer

Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.

DRUG: MEDI7247

  • Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
EXPERIMENTAL: Other advanced/metastatic target expressing solid tumors

Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies

DRUG: MEDI7247

  • Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
Primary Outcome MeasuresMeasure DescriptionTime Frame
Occurrence of Adverse EventsTo assess the occurrence of adverse eventsFrom time of informed consent through 90 days post end of treatment
Occurrence of Serious Adverse EventsTo assess the occurrence of serious adverse eventsFrom time of informed consent through 90 days post end of treatment
Occurrence of Dose Limiting ToxicitiesTo assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administrationDuring the evaluation period of 21 days post first dose
Number of patients with changes in laboratory parameters from baselineTo assess serum chemistry, hematology, urinalysis and coagulation parametersFrom time of informed consent through 90 days post end of treatment
Number of patients with changes in vital signs parameters from baselineto assess changes in vital signsfrom time of informed consent through 21 days post last dose
Number of patients with changes in electrocardiogram results from baselineto assess changes in ECGfrom time of informed consent through 21 days post last dose
Percentage of patients with changes in laboratory parameters from baselineto assess changes in serum chemistry, hematology, urinalysis, and coagulation parametersfrom time of informed consent through 90 days post end of treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
MEDI7247 maximum observed concentration (Cmax)To characterize MEDI7247 single agent PharmacokineticsFrom first dose through 90 days post end of treatment
MEDI7247 terminal half life (t1/2)To characterize single agent MEDI7247 pharmacokineticsFrom first dose through 90 days post end of treatment
MEDI7247 area under the concentration/time curve (AUC)To characterize single agent MEDI7247 pharmacokineticsfrom first dose through 90 days post end of treatment
MEDI7247 clearanceto characterize the single agent MEDI7247 pharmacokineticsfrom first dose through 90 days post end of treatment
Number of subjects who develop anti-drug antibodiesTo characterize MEDI7247 immunogenicityfirst dose through 90 days post end of treatment
Best Overall ResponseTo assess antitumor activity of MEDI7247From time of informed consent and up to 90 days post end of treatment
Objective Response Rate (ORR)To assess antitumor activity of MEDI7247From time of informed consent and up to 2 years after last subject in
Time to Response (TTR)To assess antitumor activity of MEDI7247From time of informed consent and up to 90 days post end of treatment
Duration of Response (DoR)To assess antitumor activity of MEDI7247From time of informed consent and up to 2 years after last subject in
Progression Free Survival (PFS)To assess the antitumor activity of MEDI7247From time of informed consent and up to 2 years after last subject in
Disease Control (DC)To assess antitumor activity of MEDI7247From time of informed consent and up to 2 years after last subject in
Overall Survival (OS)To assess antitumor activity of MEDI7247From time of informed consent and up to 2 years after last subject in

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Confirmed diagnosis of advanced or metastatic select solid tumors and either progression on or documented intolerance to standard therapies 2. Age ≥ 18 years at the time of screening. 3. Written informed consent and any locally required authorization 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. At least 1 measurable target lesion by CT or MRI per RECIST Version 1.1 (excluding mCRPC) 6. Adequate Liver Function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (upper limit normal), Albumin > 3 g/dL, and serum total bilirubin (TBL) ≤ 1.5 × ULN; (unless bilirubin rise is due to Gilbert's syndrome, hepatic metastases or of non-hepatic origin, in which case TBL ≤ 3 × ULN is allowed) 7. Creatinine Clearance (CrCL) ≥ 40 mL/min 8. Adequate Hematopoesis: Absolute Neutrophil Count (ANC) ≥ 1,500/μL, Platelets ≥ 100,000/μL, and Hgb ≥ 9 g/dL unassisted by transfusion or growth factor within 14 days of screening 9. Provision of archival or fresh tumor tissue at screening 10. Female patients of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception, and must agree to continue using such precautions for 90 days after the last dose of investigational product. 11. Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product.
    Exclusion Criteria:
    1. Active central nervous system (CNS) metastases, unless adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) and prednisolone 10 mg or less for more than 2 weeks prior to enrollment. For SCLC, a brain MRI scan that was conducted ≤ 28 days from Day 1 is required. 2. Residual toxicity from prior anticancer therapy not resolved to NCI CTCAE v4.03 Grade 1, with the exception of alopecia/vitiligo at the time of first dose of investigational product. For patients previously receiving immunotherapy, toxicities that are unlikely to recover to Grade 1. 3. Royal Marsden Hospital (RMH) prognostic score 2 and 3 at baseline. 4. Treatment with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 21 days, or prior palliative radiotherapy within 2 weeks of the first dose of investigational product.
    5 Prior treatment with other Pyrrolobenzodiazepine-Antibody Drug Conjugates.
    6 History of previous malignancies (except for locally curable cancers) unless a complete remission was achieved at least 3 years prior to study entry AND no additional therapy is required during the study period (except adjuvant hormonal therapy and bisphosphonate).
    7. Failure to recover from major surgery or significant traumatic injury within 21 days of first dose of study treatment.
    8 History of hepatic sinusoidal obstruction syndrome, also called veno-occlusive disease 9. History of capillary leak syndrome. 10 Blood transfusion within 14 days of study entry except when needed for disease related anemia.
    11. New York Heart Association classes III-IV congestive heart failure or serious cardiac arrhythmia requiring treatment, history of myocardial infarction, unstable angina, vascular stent, or coronary artery bypass graft within 6 months of the first dose of investigational product. 12. Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.
    13. Current severe active systemic disease including active concurrent malignancy 14. Pregnancy and/or breastfeeding at time of screening 15. Concurrent enrollment in anther clinical study involving an investigational treatment that is not an extension of another MedImmune study with the same investigational product.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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