A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors (NCT03811652) | Clinical Trial Compass
CompletedPhase 1
A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors
United States, Canada8 participantsStarted 2018-12-20
Plain-language summary
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.
Who can participate
Age range18 Years – 101 Years
SexALL
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Inclusion criteria
✓. Confirmed diagnosis of advanced or metastatic select solid tumors and either progression on or documented intolerance to standard therapies
✓. Age ≥ 18 years at the time of screening.
✓. Written informed consent and any locally required authorization
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. At least 1 measurable target lesion by CT or MRI per RECIST Version 1.1 (excluding mCRPC)
✓. 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)
✓. Creatinine Clearance (CrCL) ≥ 40 mL/min
✓. 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
Exclusion criteria
✕. 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.
✕. 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.
What they're measuring
1
Occurrence of Adverse Events
Timeframe: From time of informed consent through 90 days post end of treatment
2
Occurrence of Serious Adverse Events
Timeframe: From time of informed consent through 90 days post end of treatment
3
Occurrence of Dose Limiting Toxicities
Timeframe: During the evaluation period of 21 days post first dose
4
Number of patients with changes in laboratory parameters from baseline
Timeframe: From time of informed consent through 90 days post end of treatment
5
Number of patients with changes in vital signs parameters from baseline
Timeframe: from time of informed consent through 21 days post last dose
6
Number of patients with changes in electrocardiogram results from baseline
Timeframe: from time of informed consent through 21 days post last dose
7
Percentage of patients with changes in laboratory parameters from baseline
Timeframe: from time of informed consent through 90 days post end of treatment
✕. Royal Marsden Hospital (RMH) prognostic score 2 and 3 at baseline.
✕. 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.