New drug duo shows early promise against advanced cancers
NCT ID NCT05021120
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of two experimental drugs (AK127 and AK104) in 67 people with advanced or metastatic solid tumours that had stopped responding to standard treatments. The main goals were to check safety and find the right dose, while also looking for signs that the tumours shrank or stopped growing. The study is now complete, and results will help decide if further testing is warranted.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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67 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Apr 2025
- 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
-
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written and signed informed consent 2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies 3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy 4. Subject must have at least one measurable lesion according to RECIST Version1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. 6. Available archived or fresh tumor tissue 7. Adequate organ function. 8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate. 9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product. Exclusion Criteria: 1. History of severe hypersensitivity reactions to other mAbs. 2. Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration. 3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy 4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment 5. Any major surgery within 4 weeks prior to the first dose of treatment 6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment. 7. Active or prior documented inflammatory bowel disease 8. History of organ transplant. 9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies. 10. Known active hepatitis B or C infections or history of HIV. 11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product. 12. Patients with severe heart and lung dysfunction.
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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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Ashford Cancer Centre Research
Adelaide, Australia
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Austin Health
Melbourne, Australia
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Monash Health
Melbourne, Australia
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Southside Cancer Care Centre
Sydney, Australia
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The Kinghorn Cancer Centre, St Vincents Hospital Sydney
Sydney, Australia
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