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

Study identifier:D8540C00002

ClinicalTrials.gov identifier:NCT03811652

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1/1b Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients with Advanced or Metastatic Disease in Selected Solid Tumors

Medical condition

non small cell lung cancer squamous (NSCLC-Sq)

Phase

Phase 1

Healthy volunteers

Study drug

MEDI7247

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 101 Years

Date

Study Start Date: 20 Dec 2018

Primary Completion Date: 10 Dec 2019

Study Completion Date: 10 Dec 2019

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2020 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

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: AST and ALT <= 2.5 × ULN, Albumin > 3 g/dL, and serum 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 participants 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 study drug.
11. Nonsterilized male participants 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 study drug.

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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade 1, with the exception of alopecia/vitiligo at the time of first dose of study drug. For participants 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 study drug.
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 study drug.
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 study drug.

No locations available

Arms	Assigned Interventions
Experimental: Escalation: MEDI7247 Q3W Dose 1 Participants will receive intravenous (IV) infusion of MEDI7247 Dose 1 every three weeks (Q3W) in dose escalation phase of the study.	Drug: MEDI7247 Participants will receive IV infusion of MEDI7247 Dose 1 or Dose 2 Q3W in dose escalation phase of the study.
Experimental: Escalation: MEDI7247 Q3W Dose 2 Participants will receive IV infusion of MEDI7247 Dose 2 Q3W in dose escalation phase of the study.	Drug: MEDI7247 Participants will receive IV infusion of MEDI7247 Dose 1 or Dose 2 Q3W in dose escalation phase of the study.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]