Experimental cancer combo targets Hard-to-Treat tumours
NCT ID NCT05514132
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This early-stage trial tests a combination of two drugs—ceralasertib (a targeted therapy) and durvalumab (an immunotherapy)—in 14 Chinese patients with advanced solid tumours that have not responded to prior treatments. The main goal is to check safety and find the right dose. Researchers will also look for early signs of tumour shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ceralasertib (a targeted cancer drug) and durvalumab (an immunotherapy)
- What this could lead to
- If this combination proves safe and tolerable, it could lead to a new treatment option for advanced solid tumours that have stopped responding to standard therapies.
- What could go wrong
- This is a very early (Phase 1) and small (14 participants) study focused on safety and dosing, not effectiveness. The combination may cause significant side effects or fail to shrink tumours.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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14 people
The number who actually took part.
- Started
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Sep 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Beijing, 100021, China
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Research Site
Shandong, China
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Other studies related to the condition(s) this trial covers.
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