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Advanced Solid TumorsPhase 1NCT05393063

A Study to Evaluate the Efficacy and Safety of AK127 in Patients With Advanced Solid Tumors

A Phase 1 study testing AK127 in people with Advanced Solid Tumors, run by Akeso.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Jun 2022to Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

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.
  • Not currently enrolled in any other clinical study.
  • Receipt of any anticancer therapy within 4 weeks or within 5 half-lives of the drug prior to the first dose of AK127.
  • Symptomatic central nervous system metastases.
  • Active malignancies within the past 1 years, with the exception of tumors in this study and cured local tumors.
  • Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
Show all 18Show fewer
  • 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 AK127.
  • 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

No sites are listed yet.

Shun Lu, Chief doctor contact

13601813062

shun_lu@hotmail.com

About this study

Official title: A Phase I Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 Monotherapy in Patients With Advanced Malignant Tumors

This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies.

Read the detailed description

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies. The study, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 as a single agent, and describe Dose Limiting Toxicity (DLT).

Being tested
AK127

What participants receive

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

  • AK127Drug

    Also called Subjects will receive AK127 by intravenous administration

    Subjects will receive AK127 by intravenous administration（administered on Day 1 of each cycle, Q3W）

Study groups in NCT05393063
Study groupRoleWhat they receive
AK127ExperimentalSubjects will receive AK127 by intravenous administration
Receives: Drug: AK127

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 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug

    Measured: During the first 21 days

Secondary outcomes (9)

  1. PFS

    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

  2. ORR

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

    Measured: Up to 2 years

  3. DCR

    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

  4. DOR

    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

  5. TTR

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

    Measured: Up to 2 years

  6. Area under the Concentration-Time Curve (AUC) of AK127

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

    Measured: Cycle 1 and 4: Predose, Post-dose-5min,2 hours, 24 hours, Day 4,8 and 15; Cycle 2,3,5,6: Predose and Post-dose-5min; then Predose at Day 1, every 2 cycles (cycle length 21 days),Day30 after last dose; Up to 2 years and 1 months

  7. Maximum observed concentration (Cmax) of AK127

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

    Measured: Cycle 1 and 4: Predose, Post-dose-5min,2 hours, 24 hours, Day 4,8 and 15; Cycle 2,3,5,6: Predose and Post-dose-5min; then Predose at Day 1, every 2 cycles (cycle length 21 days),Day30 after last dose; Up to 2 years and 1 months

  8. Minimum observed concentration (Cmin) of AK127 at steady state

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

    Measured: Cycle 1 and 4: Predose, Post-dose-5min,2 hours, 24 hours, Day 4,8 and 15; Cycle 2,3,5,6: Predose and Post-dose-5min; then Predose at Day 1, every 2 cycles (cycle length 21 days),Day30 after last dose; Up to 2 years and 1 months

  9. Number and Percentage of Subjects with Anti-Drug Antibodies(ADAs) to AK127

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

    Measured: Predose on Day 1 at Cycle 1-6, then Predose at Day 1, every 2 cycles,Day30 after last dose; Up to 2 years and 1 months

Timeline

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

  1. First posted26 May 2022
  2. Study startJun 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05393063
Sponsor's protocol ID
AK127-102
Status last verified
May 2022
First submitted
23 May 2022
Last updated
26 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK127 in people with Advanced Solid Tumors, run by Akeso.

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 18 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: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Shun Lu, Chief doctor (13601813062, shun_lu@hotmail.com), or a site near the patient. 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 2 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 NCT05393063.

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 26 May 2022.

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