Selected Advanced Solid TumorsPhase 1NCT03530397
A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors
A Phase 1 study testing MEDI5752, Pemetrexed and Carboplatin in people with Selected Advanced Solid Tumors, run by MedImmune LLC at 40 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Selected Advanced Solid Tumors
- What is being tested?
- MEDI5752, Pemetrexed and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 40 sitesin 9 countries
- Study dates
- 24 Apr 2018to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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.
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- 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.
Trial locations and contacts
40 sites in 9 countries.
40 sites in 9 countries
Spain10 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 08003
Research Site
Barcelona, 08028
Research Site
Barcelona, 08035
Research Site
Barcelona, 08041
Research Site
Barcelona, 08916
Research Site
Majadahonda, 28222
Research Site
Málaga, 29010
Research Site
Pamplona, 31008
Research Site
Valencia, 46010
United States7 sites
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Chattanooga, Tennessee, 37404
Research Site
Detroit, Michigan, 48202
Research Site
Fairfax, Virginia, 22031
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10065
Research Site
Providence, Rhode Island, 02903
South Korea7 sites
Research Site
Cheongju-si, 28644
Research Site
Gyeonggi-do, 13620
Research Site
Incheon, 21565
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Italy4 sites
Research Site
Meldola, 47014
Research Site
Naples, 80131
Research Site
Ravenna, 48121
Research Site
Roma, 168
Australia3 sites
Research Site
Melbourne, 3000
Research Site
Melbourne, 3004
Research Site
Randwick, 2031
France3 sites
Research Site
Bordeaux, 33075
Research Site
Lyon, 69373
Research Site
Villejuif, 94805
Taiwan3 sites
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Taipei, 10048
About this study
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.
The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
Read the detailed description
This is a phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability, and efficacy, pharmacokinetics and Immunogenicity of MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
- Conditions
- Selected Advanced Solid Tumors
- Being tested
- MEDI5752, Pemetrexed, Carboplatin, Pembrolizumab, Paclitaxel or Nab-Paclitaxel
- Keywords
- Advanced solid tumors, MEDI5752, immuno-oncology, Cancer, PD-1/CTLA-4 Bispecific, PD-1, CTLA-4, Bispecific, Chemotherapy, Pemetrexed, Carboplatin, Pembrolizumab
- Medical subject headings
- Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI5752Biological
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
PemetrexedDrug
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
CarboplatinDrug
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
PembrolizumabBiological
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Paclitaxel or Nab-PaclitaxelDrug
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Arm A: MEDI5752 | Experimental | MEDI5752 Receives: Biological: MEDI5752 |
| Arm B: MEDI5752 and chemotherapy | Experimental | MEDI5752, pemetrexed, carboplatin and paclitaxel. Receives: Biological: MEDI5752; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel |
| Arm C: Pembrolizumab and chemotherapy | Active comparator | pembrolizumab, pemetrexed, and carboplatin Receives: Drug: Pemetrexed; Drug: Carboplatin; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase)
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase)
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.
Measured: 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 number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase)
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
Measured: Up to 21 days following the first dose
The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase)
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase)
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase)
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase)
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
Secondary outcomes (15)
Pharmacokinetics of MEDI5752: Cmax
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)
Measured: 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
Pharmacokinetics of MEDI5752: AUC
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)
Measured: 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
Pharmacokinetics of MEDI5752: Clearance
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)
Measured: 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
Pharmacokinetics of MEDI5752: t 1/2
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)
Measured: 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.
Ability of MEDI5752 to generate immune response in subjects with advanced solid tumors
The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: 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.
PD-L1 Expression in subjects with advanced solid tumors
The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.
Measured: To be assessed at baseline
Preliminary Antitumor Activity: Duration of Response
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.
Measured: 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
Preliminary Antitumor Activity: Disease Control
The endpoints for assessment of antitumor activity include disease control (DC) and is defined as CR, PR, or SD according to RECIST v1.1.
Measured: 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
Preliminary Antitumor Activity: Progression Free Survival
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.
Measured: 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
Preliminary Antitumor Activity: Overall Survival
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.
Measured: 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 number of subjects experiencing treatment related adverse events (AEs) (Dose-expansion phase)
The secondary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
The number of subjects experiencing abnormal laboratory evaluations (Dose-expansion phase)
The secondary endpoint is as assessed by the number of subjects experiencing changes in laboratory parameters from baseline.
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
The number of subjects experiencing Changes from baseline in vital signs reported as adverse events (Dose-expansion phase)
The secondary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
The number of subjects experiencing abnormal ECGs reported as adverse events (Dose-expansion phase)
The secondary endpoint is as assessed by the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
Measured: From the time of informed consent through 14 days following termination of treatment with investigational product
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-expansion phase)
The secondary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03
Measured: From the time of informed consent through 114 days following termination of treatment with investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start24 Apr 2018
- Primary completion14 Jul 2025
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selected Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepa Subramaniam, MD, MSc, Principal investigator, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530397
- Sponsor's protocol ID
- D7980C00001
- Other IDs
- 2023-509605-77-00, 2018-003075-35, 2018, 2023
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2018
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03530397
- Acronym / sponsor ID
- D7980C00001
- Conditions
- Selected Advanced Solid Tumors
- Keywords
- Advanced solid tumors, MEDI5752, immuno-oncology, Cancer, PD-1/CTLA-4 Bispecific, PD-1, CTLA-4, Bispecific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
Detailed description
This is a phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability, and efficacy, pharmacokinetics and Immunogenicity of MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: MEDI5752 | Experimental | Biological: MEDI5752MEDI5752 |
| Arm B: MEDI5752 and chemotherapy | Experimental | Biological: MEDI5752, Drug: Pemetrexed, Drug: Carboplatin, Drug: Paclitaxel or Nab-PaclitaxelMEDI5752, pemetrexed, carboplatin and paclitaxel. |
| Arm C: Pembrolizumab and chemotherapy | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Biological: Pembrolizumabpembrolizumab, pemetrexed, and carboplatin |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
- For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI5752Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. | Biological | Arm A: MEDI5752, Arm B: MEDI5752 and chemotherapy |
| PemetrexedSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation | Drug | Arm B: MEDI5752 and chemotherapy, Arm C: Pembrolizumab and chemotherapy |
| CarboplatinSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation | Drug | Arm B: MEDI5752 and chemotherapy, Arm C: Pembrolizumab and chemotherapy |
| PembrolizumabSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation | Biological | Arm C: Pembrolizumab and chemotherapy |
| Paclitaxel or Nab-PaclitaxelSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation | Drug | Arm B: MEDI5752 and chemotherapy |
Primary outcome
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.
15 secondary outcomes
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
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
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
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.
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.
PD-L1 Expression in subjects with advanced solid tumors
Time frame: To be assessed at baseline
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
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
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
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 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 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 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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Subramaniam, MD, MSc principal investigator
AstraZeneca
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI5752, Pemetrexed and Carboplatin in people with Selected Advanced Solid Tumors, run by MedImmune LLC at 40 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain, United States, South Korea, Italy, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.