Description:
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics,
Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in
Adult Subjects with Select Advanced Solid Tumors
Title
- Brief Title: MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
- Official Title: A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
D6070C00001
- NCT ID:
NCT02503774
Conditions
Interventions
Drug | Synonyms | Arms |
---|
MEDI9447 | | Monotherapy |
MEDI9447 and MEDI4736 | | Combination |
Purpose
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics,
Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in
Adult Subjects with Select Advanced Solid Tumors
Trial Arms
Name | Type | Description | Interventions |
---|
Monotherapy | Experimental | MEDI9447 (oleclumab) only | |
Combination | Experimental | MEDI9447 (oleclumab) and MEDI4736 (durvalumab) | |
Eligibility Criteria
Inclusion Criteria:
- Adult subjects; age ≥ 18
- Written and signed informed consent must be obtained
- Have histologic or cytologic documentation of solid tumor including EGFR mutated
(EGFRm) NSCLC
- Subjects must have at least 1 lesion that is measureable using RECIST guidelines
- Subjects must consent to provide archived tumor specimens or tumor biopsies for
correlative biomarker studies.
- Eastern Cooperative Oncology Group performance score of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Prior treatment with tumor necrosis factor receptor superfamily agonists including
OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, anti
PDL-1 and anti PDL-1.
- Subjects who have received prior therapy with regimens containing CTLA-4, PD-L1, or
PD-1 antagonists may be permitted to enroll under certain conditions
- Cardiac or peripheral vascular disease meeting any of the following criteria:
- Past history of myocardial infarction in the prior 12 months
- Past history of stroke or transient ischemic attack requiring medical therapy
- Congestive heart failure ≥ Class 3 based on New York Heart Association Functional
Classification
- Grade 3 or greater edema (eg, peripheral, pulmonary)
- History of Grade 3 or greater thromboembolic events in the prior 12 months
- Subjects with active tuberculosis are ineligible. In settings where there is clinical
or radiographic evidence of tuberculosis, active disease must be ruled out
- Active or prior documented autoimmune or inflammatory disorders
- Untreated central nervous system (CNS) metastatic disease
- Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B
or active hepatitis A or C
- Other invasive malignancy within 2 years except for noninvasive malignancies such as
cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the
skin, ductal carcinoma in situ of the breast that has been surgically cured
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, active peptic ulcer disease or gastritis, uncontrolled hypertension,
uncontrolled diabetes, or psychiatric illness/social situations that would limit
compliance with study requirement
Maximum Eligible Age: | 101 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Adverse Events as a Measure of Safety |
Time Frame: | From time of informed consent through 12 weeks after last dose of investigational product |
Safety Issue: | |
Description: | The primary endpoint is safety as assessed by the presence of AEs, serious adverse events (SAEs). |
Secondary Outcome Measures
Measure: | Composite measure of Preliminary antitumor activity |
Time Frame: | From the time of informed consent through an average of 1 year |
Safety Issue: | |
Description: | Assessment of antitumor activity include OR, disease control (DC), duration of response (DoR), progression-free survival (PFS), and overall survival (OS). |
Measure: | Composite measure of Pharmacokinetics of MEDI9447 or MEDI9447/MEDI4736 |
Time Frame: | From time of informed consent through 12 weeks after last dose of investigational product |
Safety Issue: | |
Description: | Including Cmax and AUC of MEDI9447 administered as a single agent and the Cmax and AUC of both MEDI9447 and MEDI4736 when administered in combination. |
Measure: | Composite measure of Immunogenicity |
Time Frame: | From time of informed consent through 12 weeks after last dose of investigational product |
Safety Issue: | |
Description: | Immunogenicity of MEDI9447 and MEDI4736 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). |
Measure: | Biomarker activity |
Time Frame: | From time of informed consent through 12 weeks after last dose of investigational product |
Safety Issue: | |
Description: | Assessment of target expression in subject samples. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | MedImmune LLC |
Trial Keywords
- Solid Tumors, MEDI9447, oleclumab, MEDI4736, durvalumab, CD73, PD-L1, EGFRm NSCLC, immunotherapy, pancreatic, colorectal
Last Updated
June 30, 2021