AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer
- Conditions
- Advanced Solid Tumours
- Interventions
- Registration Number
- NCT03421353
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a phase Ib/II, open-label multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 plus durvalumab alone or in combination with chemotherapy in patients with advanced, solid tumours and subsequently in patients with non-small-cell lung cancer (NSCLC)
- Detailed Description
This international, multicenter study was originally intended to be conducted in four parts, designated as Parts A, B, C, and D. The protocol was amended in December 2018 to remove Parts B and C. Parts B and C were intended to evaluate patients with locally advanced or metastatic Stage IV NSCLC; however, these parts of the study will not be conducted.
Part A of this study will evaluate the safety and tolerability of durvalumab and AZD9150 with and without selected chemotherapy regimens, and will include patients with advanced solid malignancies that are refractory to standard therapy or for whom no standard of care (SOC) regimen currently exists.
Part D will compare the relative bioavailability of the AZD9150 subcutaneous (SC) versus intravenous (IV) formulations in patients with confirmed solid malignancies that are refractory to standard therapy or for whom no SOC regimen currently exists. Approximately 50 to 62 PK-evaluable patients will be enrolled in Part D. Patients will be randomly assigned to either SC or IV AZD9150. For Part D, the PK Analysis set will include all patients who receive both study drugs (both AZD9150 and durvalumab) and have at least one PK sample collection.
A complementary anti-tumour strategy will be used in this study with 2 immuno-therapeutics applied to restore effective anti-tumour immunity at 2 distinct stages: promoting the effector function of T-cell responses with an anti-PD-L1 mAb, durvalumab, while hindering immune escape in the tumour bed with AZD9150. In addition, chemotherapy will be added to this combination to investigate possible future enhancement of response. In preclinical models, conventional platinum-based chemotherapy has been shown to induce T-cell activation through the release of tumour-specific antigens during cancer cell death. The elimination of persistent tolerogenic tumour antigen environment via chemotherapy-induced debulking may also play a role in generating an effective immune response. In this setting, immunotherapy has the potential to mount an ongoing and dynamic immune response that can kill tumour cells for an extended time.
Part A of the study will be conducted in five arms, designated Arms A1, A2, A3, A4, and A5. The primary objective of Part A is to assess the safety and tolerability, and determining the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of AZD9150 plus durvalumab in patients with advanced solid malignancies. In addition, another primary objective is to assess the safety and tolerability, and determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of AZD9150 plus durvalumab in combination with standard chemotherapy regimens in patients with advanced solid malignancies. Approximately 30 to 78 DLT-evaluable patients will be enrolled in Part A.
In Arm A1, patients will receive AZD9150 by (IV) infusion Q2W + durvalumab by IV infusion Q4W. Chemotherapy will not be given in Arm A1.
Arm A2 patients will receive AZD9150 IV QW + durvalumab IV Q3W, cisplatin by slow IV infusion over 1-4 hours on Day 1 + 5-fluorouracil (5FU) by continuous IV infusion over 96 hours (Days 1 through 4, repeated every 3 weeks for up to 18 weeks). In Arm A2 there will be a AZD9150 + chemotherapy lead-in period prior to durvalumab dosing. The last chemotherapy dose will be given in Week 15. After discontinuation of chemotherapy the regimen will include AZD9150 IV QW + durvalumab IV Q4W. Administration of durvalumab will continue Q3W through Week 19, at which time the schedule will switch to Q4W (e.g., Week 23, 27, 31, etc.).
Depending on the results from Arm A2, Arm A3 may not be conducted. If the Safety Review Committee (SRC) decides to open Arm A3, the SRC will determine the starting dose. Patients will be administered one of the following 4 chemotherapy regimens in combination with AZD9150 and durvalumab appropriate for their tumour type:
* In Arm A3, patients will receive cisplatin by slow IV infusion over 1-4 hours on Day 1 + 5FU by continuous IV infusion over 96 hours (Days 1 through 4, repeated every 3 weeks for up to 18 weeks).
* In Arm A4, patients will receive gemcitabine by IV infusion over 30 minutes on Days 1 and 8 every 3 weeks for 12 to 18 weeks, plus either:
* for cisplatin-eligible patients: cisplatin IV over 30 minutes on Day 1 (every 3 weeks for up to 12 to 18 weeks); or
* for cisplatin-ineligible patients: carboplatin IV over 30 to 60 minutes on Day 1 (every 3 weeks for up to 12 to 18 weeks).
* In Arm A5, patients will receive carboplatin at AUC 5 IV over 30 to 60 minutes on Day 1 + nab-paclitaxel IV over 30 to 40 minutes on Days 1, 8, and 15 (every 3 weeks for up to 12 to 18 weeks)
There will be an AZD9150 7-day lead-in period (termed Week 0) in all arms in all parts of the study. AZD9150 will be given IV on Days 1,3, and 5 of the lead-in week. When chemotherapy is administered, the dosing of chemotherapy will also commence during the lead-in period with AZD9150. In Arm A2 of Part A, dosing with AZD9150 IV, durvalumab, and chemotherapy will commence on Day 1 of Week 0. In Part D, dosing with AZD9150 IV or SC will commence on Day 1 of Week 0
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A3 Cisplatin Depending on the results of Arm A2, Arm A3 may not be conducted. If Arm A3 is conducted, patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + cisplatin on Day 1 + 5-flourouracil (5-FU) over Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A2 5-Flourouracil Patients will receive AZD9150 once weekly (QW) + durvalumab every three weeks (Q3W) + Cisplatin on Day 1 + 5-flourouracil (5-FU) on Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A5 Nab-paclitaxel Patients will receive AZD9150 every two weeks (Q2W) plus durvalumab every three weeks (Q3W) plus carboplatin on Day 1 plus nab-paclitaxel on Days 1, 8, and 15 (every 3 weeks for up to 12-18 weeks). There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A4 Cisplatin Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: * For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or * For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A2 Cisplatin Patients will receive AZD9150 once weekly (QW) + durvalumab every three weeks (Q3W) + Cisplatin on Day 1 + 5-flourouracil (5-FU) on Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A3 5-Flourouracil Depending on the results of Arm A2, Arm A3 may not be conducted. If Arm A3 is conducted, patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + cisplatin on Day 1 + 5-flourouracil (5-FU) over Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A4 Durvalumab Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: * For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or * For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm D: AZD9150 IV AZD9150 Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150. Arm D: AZD9150 IV Durvalumab Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150. Arm D: AZD9150 SC Durvalumab Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150. Arm A1 AZD9150 Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every four weeks (Q4W). There will be a 1 week AZD9150 lead-in prior to durvalumab dosing. Arm A2 AZD9150 Patients will receive AZD9150 once weekly (QW) + durvalumab every three weeks (Q3W) + Cisplatin on Day 1 + 5-flourouracil (5-FU) on Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A4 AZD9150 Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: * For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or * For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A5 AZD9150 Patients will receive AZD9150 every two weeks (Q2W) plus durvalumab every three weeks (Q3W) plus carboplatin on Day 1 plus nab-paclitaxel on Days 1, 8, and 15 (every 3 weeks for up to 12-18 weeks). There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A3 AZD9150 Depending on the results of Arm A2, Arm A3 may not be conducted. If Arm A3 is conducted, patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + cisplatin on Day 1 + 5-flourouracil (5-FU) over Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm D: AZD9150 SC AZD9150 Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150. Arm A1 Durvalumab Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every four weeks (Q4W). There will be a 1 week AZD9150 lead-in prior to durvalumab dosing. Arm A2 Durvalumab Patients will receive AZD9150 once weekly (QW) + durvalumab every three weeks (Q3W) + Cisplatin on Day 1 + 5-flourouracil (5-FU) on Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A3 Durvalumab Depending on the results of Arm A2, Arm A3 may not be conducted. If Arm A3 is conducted, patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + cisplatin on Day 1 + 5-flourouracil (5-FU) over Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A4 Carboplatin Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: * For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or * For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A4 Gemcitabine Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: * For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or * For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A5 Durvalumab Patients will receive AZD9150 every two weeks (Q2W) plus durvalumab every three weeks (Q3W) plus carboplatin on Day 1 plus nab-paclitaxel on Days 1, 8, and 15 (every 3 weeks for up to 12-18 weeks). There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing. Arm A5 Carboplatin Patients will receive AZD9150 every two weeks (Q2W) plus durvalumab every three weeks (Q3W) plus carboplatin on Day 1 plus nab-paclitaxel on Days 1, 8, and 15 (every 3 weeks for up to 12-18 weeks). There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
- Primary Outcome Measures
Name Time Method Part D: Area under the plasma concentration versus time curve at steady state [AUC(ss)] of AZD9150 administered once per week in combination with durvalumab. Blood samples for the PK analysis of AZD9150 will be collected at prespecified intervals during Weeks 0, 1, 5, 6, and 9. Pharmacokinetic parameters will be derived from the measured plasma concentration of AZD9150. The area under the plasma concentration versus time curve \[AUC(ss)\] will be compared in subjects receiving AZD9150 subcutaneoulsy vs. intravenously.
Part A: Maximum Tolerated Dose (MTD) in subjects receiving AZD9150 plus durvalumab and AZD9150 plus durvalumab plus chemotherapy. Through study completion (an average of 6 months). Dose-limiting toxicities (DLTs) will be assessed through 5 weeks for patients who do not receive chemotherapy or 3 weeks for patients receiving chemotherapy. The Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) will be determined by assessment of the incidence of dose-limiting toxicities (DLTs). DLTs may come from the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), the change from baseline in vital signs, clinical chemistry, haemotology, and urinalysis parameters will be evaluated for each treatment arm in Part A of the study.
Part D: Minimum plasma concentration at steady state [Ctrough (ss)] of AZD9150 administered once per week in combination with durvalumab. Blood samples for the PK analysis of AZD9150 will be collected at prespecified intervals during Weeks 0, 1, 5, 6, and 9. Pharmacokinetic parameters will be derived from the measured plasma concentration of AZD9150. The minimum plasma concentration of AZD9150 at steady state \[Ctrough(ss)\] will be determined for subjects receiving AZD9150 once per week in combination with durvalumab.
- Secondary Outcome Measures
Name Time Method Part A: Duration of Overall Response (DoR) Throughout the study (approximately 6 months). Efficacy parameters as defined by RECIST v1.1 for each combination (with and without chemotherapy) and schedule include: disease control rate (DCR) at 12 weeks, duration of overall response (DOR), and progression-free survival (PFS).
Part A: Trough plasma concentration (Ctrough) of AZD9150 after single-dose. Blood samples for the PK analysis of AZD9150 will be collected at prespecified intervals during Weeks 0, 1, 5, 6, and 9. The trough plasma concentration (Ctrough) of AZD9150 after single dose and at steady state after multiple doses in combination with durvalumab Q4W will be determined.
Part A: Durvalumab anti-drug antibody titres Blood samples for durvalumab anti-drug antibodies (ADAs) will be collected predose on prespecified dosing days up to 13 weeks. Unwanted immunogenicity in the form of anti-drug-antibodies (ADAs) will be assessed.
Part A: Disease Control Rate (DCR) 12 weeks Efficacy parameters as defined by RECIST v1.1 for each combination (with and without chemotherapy) and schedule include: disease control rate (DCR) at 12 weeks, duration of overall response (DOR), and progression-free survival (PFS).
Part A: Baseline tumour PD-L1 expression Pre-dose Baseline tumour PDL1 expression will be evaluated for potential correlation with drug activity or the ability to prospectively identify patients likely to respond to treatment.
Immunohistochemistry (IHC) for PD-L1 will be carried out using a tumour sample from an archival biopsy or one taken at screening.Part A: Peak plasma concentration (Cmax) of AZD9150 after single-dose. Blood samples for the PK analysis of AZD9150 will be collected at prespecified intervals during Weeks 0, 1, 5, 6, and 9. The peak plasma concentration (Cmax) of AZD9150 after single dose and at steady state after multiple doses in combination with durvalumab Q4W will be determined.
Part A: Peak plasma concentration (Cmax,ss) of AZD9150 after multiple doses. Blood samples for the PK analysis of AZD9150 will be collected at prespecified intervals during Weeks 0, 1, 5, 6, and 9. The peak plasma concentration (Cmax,ss) of AZD9150 at steady state after multiple doses in combination with durvalumab Q4W will be determined.
Part D: Peak plasma concentration (Cmax,ss) of AZD9150 at steady state after multiple doses. Through study completion (an average of 6 months) The peak plasma concentration (Cmax) of AZD9150 after single dose and at steady state after multiple doses when given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: Area under the plasma concentration versus time curve [AUC(0-inf)] after single-dose. Through study completion (an average of 6 months) The area under the plasma concentration versus time curve from zero time to infinity \[AUC(0-inf)\] of AZD9150 after single dose given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: The elimination half-life (t1/2) of AZD9150 after single-dose Through study completion (an average of 6 months) The elimination half-life (t1/2) after single-dose will be calculated for AZD9150 given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part A: Progression-Free Survival (PFS) From the date of documented complete response or partial response, whichever comes first, until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months Efficacy parameters as defined by RECIST v1.1 for each combination (with and without chemotherapy) and schedule include: disease control rate (DCR) at 12 weeks, duration of overall response (DOR), and progression-free survival (PFS).
Part A: AZD9150 anti-drug antibody titres Blood samples for AZD9150 anti-drug antibodies (ADAs) will be collected predose on prespecified dosing days up to 9 weeks. Unwanted immunogenicity in the form of anti-drug-antibodies (ADAs) will be assessed.
Part A: STAT3 protein in tumour biopsies Predose and 3 weeks after start of treatment STAT3 knockdown will be assessed in tumour biopsies taken on-treatment at Week 3, Day 1. Baseline and on-treatment biopsies will be used to measure STAT3 expression levels by immunohistochemistry.
Part A: Area under the plasma concentration versus time curve [AUC(ss)] at steady state after multiple doses. Through study completion (an average of 6 months) The area under the plasma concentration versus time curve \[AUC(ss)\] of AZD9150 at steady state after multiple in combination with durvalumab Q4W will be determined.
Part D: Peak plasma concentration (Cmax) of AZD9150 after single-dose. Through study completion (an average of 6 months) The peak plasma concentration (Cmax) of AZD9150 after single dose and at steady state after multiple doses when given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part A: Trough plasma concentration (Ctrough,ss) of AZD9150 after multiple doses. Blood samples for the PK analysis of AZD9150 will be collected at prespecified intervals during Weeks 0, 1, 5, 6, and 9. The trough plasma concentration (Ctrough,ss) of AZD9150 at steady state after multiple doses in combination with durvalumab Q4W will be determined.
Part D: Injection site tolerability for patients receiving subcutaneous injections. Through study completion (an average of 6 months) Pain, tenderness, redness, and other symptoms will be assessed for subcutaneous injection of AZD9150.
Part D: The systemic clearance (CL) of AZD9150 after single-dose. Through study completion (an average of 6 months) The systemic clearance (CL) after single-dose will be calculated for AZD9150 given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: The systemic clearance [CL(ss)] of AZD9150 after multiple doses. Through study completion (an average of 6 months) The systemic clearance \[CL(ss)\] after multiple doses will be calculated for AZD9150 given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part A: Area under the plasma concentration versus time curve (AUC) of AZD9150 after single-dose. Through study completion (an average of 6 months) The area under the plasma concentration versus time curve (AUC) of AZD9150 after single-dose given in combination with durvalumab Q4W will be determined.
Part D: The incidence of adverse events (AEs) in subjects receiving AZD9150. Through study completion (an average of 6 months) The incidence of adverse events will be determined for each treatment arm in Part D of the study.
Part D: Area under the plasma concentration versus time curve from time zero to 48 hours [AUC(0-48] after single-dose. Through study completion (an average of 6 months) The area under the plasma concentration versus time curve from zero time to 48 hours \[AUC(0-48)\] of AZD9150 after single dose given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: The apparent systemic clearance (CL/F) of AZD9150 after single-dose. Through study completion (an average of 6 months) The apparent systemic clearance (CL/F) after single-dose will be calculated for AZD9150 given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: The mean residence time (MRT) of AZD9150 after single-dose. Through study completion (an average of 6 months) The mean residence time (MRT) after single-dose will be calculated for AZD9150 given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: Injection site tolerability of AZD9150 given by subcutaneous injection every 4 weeks relative to AZD9150 200 mg IV QW in Through study completion (an average of 6 months) Injection site tolerability will be assessed by careful visual observation of both subcutaneous and intravenous injection sites and questioning the patient about adverse events at the injection site.
Part D: The incidence of serious adverse events (SAEs) in subjects receiving AZD9150. Through study completion (an average of 6 months) The incidence of serious adverse events will be determined for each treatment arm in Part D of the study.
Part D: Time to peak plasma concentration (tmax) of AZD9150 after single-dose. Through study completion (an average of 6 months) The time to peak plasma concentration (tmax) of AZD9150 after single dose when given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: Area under the plasma concentration versus time curve [AUC(ss)] at steady state after multiple doses. Through study completion (an average of 6 months) The area under the plasma concentration versus time curve \[AUC(ss)\] of AZD9150 at steady state after multiple doses given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: Area under the plasma concentration versus time curve [AUC(0-t)] after single-dose. Through study completion (an average of 6 months) The area under the plasma concentration versus time curve from zero time to time t \[AUC(0-t)\] of AZD9150 after single dose given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Part D: The volume of distribution (Vz/F) of AZD9150 after single-dose. Through study completion (an average of 6 months) The volume of distribution (Vz/F) after single-dose will be calculated for AZD9150 given subcutaneously QW relative to intravenous administration QW in combination with durvalumab Q4W will be determined.
Trial Locations
- Locations (1)
Research Site
🇺🇸Fairfax, Virginia, United States