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Advanced Solid TumorsPhase 1/2NCT05951608

A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing AK127 in combination with AK112 in people with Advanced Solid Tumors, run by Akeso at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in combination with AK112 in Patients with Advanced Malignant Tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
AK127 in combination with AK112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
16 Oct 2023to 15 Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
  • Life expectancy ≥3 months；
  • 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.
  • Adequate organ function.
  • Patients of childbearing potential must agree to use effective contraceptive measures.

Who cannot join

  • The patient has received prior immunotherapy against TIGIT target.
  • The patient had previously been treated with anti-PD -(L)1 and anti-VEGF targets.
  • Currently enrolled in any other clinical study.
  • Receipt of any anticancer therapy within 4 weeks prior to the first dose of Investigational drug;
  • Symptomatic central nervous system metastases.
  • Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
Show all 19Show fewer
  • Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
  • There is a history of major diseases 1 year prior to the first dose.
  • Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
  • Received chest radiation therapy prior to the first dose
  • Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
  • Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
  • Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of Investigational drug.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Known history of active tuberculosis.
  • History of organ transplant or hematopoietic stem cell.
  • History of primary immunodeficiency.
  • 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.
  • Other cases deemed inappropriate by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 430022

Other trials in China

About this study

Official title: A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK112 in Patients With Advanced Malignant Tumors

A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in combination with AK112 in Patients with Advanced Malignant Tumors

Read the detailed description

The study consisted of two parts. The first part, Phase Ib is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity of AK127 in combination with AK112 in adult subjects with advanced solid tumor malignancies. The part, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 in combination with AK112, and describe Dose Limiting Toxicity (DLT).The second part, Phase II is to Evaluate the anti-tumor activity of AK127 in combination with AK112 in different tumor species cohorts.

Being tested
AK127 in combination with AK112

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK127 in combination with AK112Drug

    AK127 in combination with AK112 (administered on Day 1 of each cycle, Q3W) up to 2 years

Study groups in NCT05951608
Study groupRoleWhat they receive
AK127 in combination with AK112ExperimentalSubjects will receive AK127 in combination with AK112 by intravenous administration
Receives: Drug: AK127 in combination with AK112

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

    Measured: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

  2. Number of participants with a Dose Limiting Toxicity (DLT)

    DLTs will be assessed during the first 3 weeks of treatment for dose-escalation Ib phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment

    Measured: During the first 3 weeks

  3. Number of participants with ORR

    Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by investigator based on RECIST v1.1

    Measured: Up to 2 years

  4. Progression-Free Survival

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Disease control rate

    DCR, which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1

    Measured: Up to 2 years

  2. Duration of response

    DoR, which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  3. Time to Progress

    TTR is defined as the time to response base on RECIST v1.1

    Measured: Up to 2 years

  4. AUC of AK127 and AK112

    Area under the curve (AUC) of AK127 and AK112

    Measured: Up to 2 years

  5. PK of AK127 and AK112

    The endpoints for assessment of PK of AK127 and AK112 include serum concentrations of AK127 and AK112 at different timepoints after AK127 and AK112 administration

    Measured: Up to 2 years

  6. Cmax of AK127 and AK112

    Maximum observed concentration (Cmax) of AK127 and AK112

    Measured: Up to 2 years

  7. Cmin of AK127 and AK112 at steady state

    Minimum observed concentration (Cmin) of AK127 and AK112 at steady state

    Measured: Up to 2 years

  8. The immunogenicity of AK127 and AK112

    The immunogenicity of AK127 and AK112 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start16 Oct 2023
  3. Primary completion1 May 2026 (estimated)
  4. Study completion15 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951608
Sponsor's protocol ID
AK127-104
Status last verified
Mar 2026
First submitted
11 Jul 2023
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK127 in combination with AK112 in people with Advanced Solid Tumors, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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