New drug duo takes on advanced cancers in early trial
NCT ID NCT05951608
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two experimental drugs, AK127 and AK112, together in people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety and see if the combination can shrink tumors. About 216 adults aged 18 to 75 with good performance status are being enrolled.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Aug 2026
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 to 75 years
- 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. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 4. Life expectancy ≥3 months; 5. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy. 6. Adequate organ function. 7. Patients of childbearing potential must agree to use effective contraceptive measures. Exclusion Criteria: 1. The patient has received prior immunotherapy against TIGIT target. 2. The patient had previously been treated with anti-PD -(L)1 and anti-VEGF targets. 3. Currently enrolled in any other clinical study. 4. Receipt of any anticancer therapy within 4 weeks prior to the first dose of Investigational drug; 5. Symptomatic central nervous system metastases. 6. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors 7. Active autoimmune disease requiring systemic treatment prior to the start of study treatment. 8. There is a history of major diseases 1 year prior to the first dose. 9. Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose 10. Received chest radiation therapy prior to the first dose 11. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage. 12. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). 13. Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of Investigational drug. 14. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 15. Known history of active tuberculosis. 16. History of organ transplant or hematopoietic stem cell. 17. History of primary immunodeficiency. 18. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. 19. Other cases deemed inappropriate by the investigator.
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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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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 430022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
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- Oral drug RVU120 put to the test against advanced solid tumors