A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT03530397 |
Recruitment Status :
Recruiting
First Posted : May 21, 2018
Last Update Posted : November 1, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Selected Advanced Solid Tumors | Biological: MEDI5752 Drug: Pemetrexed Drug: Carboplatin Biological: Pembrolizumab Drug: Paclitaxel or Nab-Paclitaxel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 366 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors. |
Actual Study Start Date : | April 24, 2018 |
Estimated Primary Completion Date : | March 20, 2024 |
Estimated Study Completion Date : | March 20, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A: MEDI5752
MEDI5752
|
Biological: MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. |
Experimental: Arm B: MEDI5752 and chemotherapy
MEDI5752, pemetrexed, carboplatin and paclitaxel.
|
Biological: MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. Drug: Pemetrexed Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Drug: Carboplatin Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Drug: Paclitaxel or Nab-Paclitaxel Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
Active Comparator: Arm C: Pembrolizumab and chemotherapy
pembrolizumab, pemetrexed, and carboplatin
|
Drug: Pemetrexed
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Drug: Carboplatin Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Biological: Pembrolizumab Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
- The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
- Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase) [ Time Frame: From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after the last patient starts treatment, whichever should occur first ]The primary endpoint of antitumor activity include Objective Response and will be based on all post baseline disease assessments that occur prior to initiation of subsequent anticancer therapy.
- The number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase) [ Time Frame: Up to 21 days following the first dose ]The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
- The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
- The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
- The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
- The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.
- Pharmacokinetics of MEDI5752: Cmax [ Time Frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment ]The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include maximum observed concentration (Cmax)
- Pharmacokinetics of MEDI5752: AUC [ Time Frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment ]The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include area under the concentration-time curve (AUC)
- Pharmacokinetics of MEDI5752: Clearance [ Time Frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment ]The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include clearance (CL)
- Pharmacokinetics of MEDI5752: t 1/2 [ Time Frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment. ]The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include terminal phase half life (t 1/2)
- Ability of MEDI5752 to generate immune response in subjects with advanced solid tumors [ Time Frame: To be assessed at Day 1, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment. ]The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)
- PD-L1 Expression in subjects with advanced solid tumors [ Time Frame: To be assessed at baseline ]The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.
- Preliminary Antitumor Activity: Duration of Response [ Time Frame: From the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first ]The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the documentation of OR to the first documentation of disease progression or death due to any cause.
- Preliminary Antitumor Activity: Disease Control [ Time Frame: From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first ]The endpoints for assessment of antitumor activity include disease control (DC) and is defined as CR, PR, or SD according to RECIST v1.1.
- Preliminary Antitumor Activity: Progression Free Survival [ Time Frame: From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first ]The endpoints for assessment of antitumor activity include progression free survival (PFS) and is defined as the duration measured from the start of treatment with investigational product to the first documentation of disease progression or death due to any cause.
- Preliminary Antitumor Activity: Overall Survival [ Time Frame: From the first dose of study drug through the end of study, or date of death, or two years after last subject starts treatment whichever should occur first ]The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the duration measured from the start of treatment with investigational product until death due to any cause.
- The number of subjects experiencing treatment related adverse events (AEs) (Dose-expansion phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The secondary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
- The number of subjects experiencing abnormal laboratory evaluations (Dose-expansion phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The secondary endpoint is as assessed by the number of subjects experiencing changes in laboratory parameters from baseline.
- The number of subjects experiencing Changes from baseline in vital signs reported as adverse events (Dose-expansion phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The secondary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
- The number of subjects experiencing abnormal ECGs reported as adverse events (Dose-expansion phase) [ Time Frame: From the time of informed consent through 14 days following termination of treatment with investigational product ]The secondary endpoint is as assessed by the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
- The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-expansion phase) [ Time Frame: From the time of informed consent through 114 days following termination of treatment with investigational product ]The secondary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Age ≥ 18 years at the time of screening
- World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- Life expectancy ≥ 12 weeks
- Histologically or cytologically-confirmed advanced solid tumors
- Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
- Subjects must have at least one measurable lesion
- Adequate organ and marrow function
- Written informed consent and any locally required authorization
- Subjects must provide tumor material as applicable
Exclusion Criteria
- Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
- Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
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For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
- Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
- Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency:
- History of organ transplant
- Known allergy or reaction to any component of the planned study treatment.
- Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
- Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
- Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
- Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530397
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
United States, Michigan | |
Research Site | Recruiting |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
Research Site | Recruiting |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Research Site | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Rhode Island | |
Research Site | Recruiting |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
Research Site | Recruiting |
Chattanooga, Tennessee, United States, 37404 | |
Research Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
United States, Virginia | |
Research Site | Not yet recruiting |
Fairfax, Virginia, United States, 22031 | |
Australia | |
Research Site | Recruiting |
Melbourne, Australia, 3000 | |
Research Site | Active, not recruiting |
Melbourne, Australia, 3004 | |
Research Site | Active, not recruiting |
Randwick, Australia, 2031 | |
France | |
Research Site | Recruiting |
Bordeaux Cedex, France, 33075 | |
Research Site | Recruiting |
Lyon, France, 69373 | |
Research Site | Recruiting |
Villejuif Cedex, France, 94805 | |
Italy | |
Research Site | Recruiting |
Meldola, Italy, 47014 | |
Research Site | Withdrawn |
Milano, Italy, 20133 | |
Research Site | Recruiting |
Napoli, Italy, 80131 | |
Research Site | Recruiting |
Ravenna, Italy, 48121 | |
Research Site | Recruiting |
Roma, Italy, 168 | |
Korea, Republic of | |
Research Site | Recruiting |
Cheongju-si, Korea, Republic of, 28644 | |
Research Site | Recruiting |
Gyeonggi-do, Korea, Republic of, 13620 | |
Research Site | Recruiting |
Incheon, Korea, Republic of, 21565 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 05505 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 06351 | |
Netherlands | |
Research Site | Recruiting |
Amsterdam, Netherlands, 1066 CX | |
Portugal | |
Research Site | Recruiting |
Lisboa, Portugal, 1649-035 | |
Research Site | Recruiting |
Porto, Portugal, 4200-072 | |
Spain | |
Research Site | Recruiting |
A Coruna, Spain, 15006 | |
Research Site | Recruiting |
Barcelona, Spain, 08003 | |
Research Site | Recruiting |
Barcelona, Spain, 08028 | |
Research Site | Recruiting |
Barcelona, Spain, 08035 | |
Research Site | Recruiting |
Barcelona, Spain, 08041 | |
Research Site | Recruiting |
Barcelona, Spain, 08916 | |
Research Site | Recruiting |
Majadahonda, Spain, 28222 | |
Research Site | Recruiting |
Malaga, Spain, 29010 | |
Research Site | Recruiting |
Pamplona, Spain, 31008 | |
Research Site | Recruiting |
Valencia, Spain, 46010 | |
Taiwan | |
Research Site | Recruiting |
Taichung, Taiwan, 40705 | |
Research Site | Recruiting |
Tainan, Taiwan, 70403 | |
Research Site | Recruiting |
Taipei, Taiwan, 10048 |
Principal Investigator: | Deepa Subramaniam, MD, MSc | AstraZeneca |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT03530397 |
Other Study ID Numbers: |
D7980C00001 |
First Posted: | May 21, 2018 Key Record Dates |
Last Update Posted: | November 1, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Advanced solid tumors MEDI5752 immuno-oncology Cancer PD-1/CTLA-4 Bispecific PD-1 |
CTLA-4 Bispecific Chemotherapy Pemetrexed Carboplatin Pembrolizumab |
Neoplasms Paclitaxel Carboplatin Pembrolizumab Pemetrexed Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |