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New drug duo shows early promise against advanced cancers

NCT ID NCT05021120

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

67 people

The number who actually took part.

Started

Oct 2021

Finished

Apr 2025

Lead sponsor

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

Anyone

Healthy volunteers

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

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

  • Ashford Cancer Centre Research

    Adelaide, Australia

  • Austin Health

    Melbourne, Australia

  • Monash Health

    Melbourne, Australia

  • Southside Cancer Care Centre

    Sydney, Australia

  • The Kinghorn Cancer Centre, St Vincents Hospital Sydney

    Sydney, Australia

More trials for these conditions

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