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Trial Title:
A Study to Evaluate the Safety and Pharmacokinetics of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours
NCT ID:
NCT05514132
Condition:
Advanced Solid Tumours
Conditions: Official terms:
Neoplasms
Durvalumab
Antibodies, Monoclonal
Conditions: Keywords:
Phase 1
Safety
Tolerability
Pharmacokinetics
Advanced solid tumours
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ceralasertib
Description:
Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific
protein kinase, ATR, with good selectivity against other phosphatidylinositol
3-kinase-related kinase family members.
Arm group label:
Ceralasertib in Combination with Durvalumab
Other name:
Ceralasertib taken orally
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Durvalumab is a human mAb of the immunoglobulin G 1 kappa subclass that blocks the
interaction of PD-L1 (but not PD-L2) with PD-1 on T cells and CD80 (B7.1) on immune
cells.
Arm group label:
Ceralasertib in Combination with Durvalumab
Other name:
Durvalumab Infusion
Summary:
This is a Phase 1, open-label study of ceralasertib given in combination with durvalumab
in Chinese participants with advanced solid tumours. In each cohort, a monotherapy
lead-in period (Cycle 0, duration of 7 or 14 days), prior to dosing with durvalumab, is
added to investigate the PK profile and safety/tolerability of ceralasertib in Chinese
participants.
This study is designed to investigate and characterise preliminary safety, tolerability,
and PK of ceralasertib in DLT-evaluable Chinese participants
Detailed description:
Primary Objective:
To assess the safety and tolerability of ceralasertib in combination with durvalumab in
Chinese patients with advanced solid tumours refractory/resistant to prior SoC therapy or
for which no appropriate SoC therapy exists.
Secondary Objective:
To characterise the PK profile of ceralasertib after single- and multiple-doses
administration. To characterise the anti-tumour activity and efficacy of ceralasertib in
combination with durvalumab in Chinese patients .
This is a Phase 1, open-label study of ceralasertib given in combination
with durvalumab in Chinese patients with advanced solid tumours.Results from this study
will provide dose rationale for future investigations.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed written informed consent.
2. At least 18 years of age at the time of signing the ICF.
3. Histological or cytological confirmation advanced solid tumour with
refractory/resistance to a prior line of anti-PD-1/PD-L1-containing therapy
(received as monotherapy or in combination) or for which no SoC exists.
4. Ability to swallow oral medication intact and retain it.
5. ECOG/WHO performance status of 0 to 1.
6. Must have a life expectancy of at least 12 weeks.
7. Participant must have had a treatment-free interval of ≥ 3 weeks from any prior
therapy before the first dose of study treatment.
8. Body weight > 35 kg and no cancer-associated cachexia (eg, CTCAE Grade 2 or worse
weight loss over the 3 months prior to the Screening Visit).
9. Contraceptive use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
1. Inadequate bone marrow reserve or organ function
2. As judged by the investigator, any evidence of uncontrolled intercurrent illness,
that in the investigator's opinion makes it undesirable for the participant to
participate in the study.
3. Spinal cord compression, leptomeningeal disease, or brain metastases, unless
asymptomatic, treated, stable, and not requiring continuous corticosteroids
4. As judged by the investigator, any active disease or condition that will interfere
significantly with the absorption, distribution, metabolism, or excretion of oral
therapy
5. History of another primary malignancy.
6. As judged by the Investigator, any evidence of severe or uncontrolled systemic
diseases, active bleeding diatheses, renal transplant, or active infection including
any patient known to have hepatitis B, hepatitis C, and HIV.
7. Known history of HIV infection.
8. Active cardiacvascular disease be consider as clinical significant.
9. Active or prior documented autoimmune or inflammatory disorders
10. Prior exposure to a CHK1 or ATR inhibitor.
11. As judged by the investigator, any unresolved treatment-related toxicities from
previous anti-cancer therapy of CTCAE v5.0 Grade ≥ 2
12. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer
treatment.
13. Participants must not have experienced a toxicity that led to permanent
discontinuation of prior anti-PD-1 or anti-PD-L1 immunotherapy.
14. Participants must not have required the use of additional immunosuppression other
than corticosteroids for the management of an AE, not have experienced recurrence of
an AE if re-challenged
15. Participants with a known allergy or hypersensitivity to any of the study drugs or
any of the study drug excipients
16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).
17. Judgment by the investigator that the participant should not participate in the
study if the participant is unlikely to comply with study procedures, restrictions
and requirements.
18. Previous enrolment in the present study.
19. For women only - currently pregnant (confirmed with positive pregnancy test) or
breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Start date:
September 23, 2022
Completion date:
April 1, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05514132
