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Neoplasms MalignantPhase 1NCT04728334

A Phase 1 Dose Escalation and Expansion Study of AK117

A Phase 1 study testing AK117 in people with Neoplasms Malignant, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, open label, single arm, Phase 1，dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacodynamics, PK, immunogenicity, and preliminary antitumor activity of AK117 administered intravenously to adult subjects with relapsed/refractory advanced or metastatic… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms Malignant
What is being tested?
AK117
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteChina
Study dates
23 Mar 2021to 12 May 2023
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

  • All Subjects
  • Able to provide written and signed informed consent and any locally required authorization obtained from the subject/legal representative, which must be obtained prior to performing any protocol related procedures.
  • Men or women aged ≥18 years and ≤75 at the time of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
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  • Subjects must provide the tumor tissue samples after the diagnosis of solid tumor or lymphoma.
  • Adequate organ function.
  • Subjects with Solid Tumors：Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available. Subject must have at least 1 measurable lesion according to RECIST v1.1.
  • Subjects with Lymphomas：Subjects must have histologically confirmed non-Hodgkin lymphoma(NHL), which may include transformed lymphoma, relapsed or refractory to autologous hematopoietic stem cell transplantation, or at least 2 lines of prior chemotherapy. Subjects must have disease that is measurable or assessable for response as per Lugano Classification 2014.

Who cannot join

  • All Subjects
  • Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study.
  • Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured.
  • Receipt: The last cycle of anticancer therapy within 3 weeks prior to the first dose of investigational product; Anticancer small molecule targeted agent, palliative local treatment for non-target lesions, non-specific immunomodulatory therapy within 2 weeks prior to the first dose of investigational product; Chinese medicines with anti-tumor indications within 1 week prior to the first dose of investigational product; Any major surgery within 4 weeks; RBC infusion within 3 months.
  • Metastasis or infiltration of brainstem and meninges;Metastasis or compression of the spinal cord; Active brain/central nervous system (CNS) metastases.
  • Subjects with clinical symptoms or repeated drainage of pleural effusion, pericardial effusion or ascites.
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  • Cancer invasion of important surrounding organs or risk of esophageal tracheal fistula or esophageal pleural fistula.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
  • Known active hepatitis B or C infections (known positive HBsAg result or positive HCV antibody with detectable HCV ribonucleic acid [RNA] results).
  • Active or prior documented autoimmune disease that may relapse.
  • History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.
  • History of hemolytic anemia of any cause within 3 months prior to the first dose of investigational product.
  • History of defects in RBC production, or hemoglobin production or metabolism.History of hemophagocytic lymphohistiocytosis.
  • Previous or current gastrointestinal perforation, surgical incision, wound healing complications and bleeding events.
  • Patients with clinically significant cardio-cerebrovascular disease.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of toxicities not considered a safety risk.
  • Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to the first dose of investigational product.
  • Subjects with prior use of anti-PD-1, anti-PD-L1, anti-CTLA-4, or any other immuno-oncology agents, receipt of the following treatments or procedures: Use of immunotherapy or IO drug within 21 days prior to the first dose; Subjects had an irAE that resulted in permanent discontinuation of previous immunotherapy; Subjects had a history of grade 3 or higher irAE or cardiac, neurological, or ocular irAE of any grade at the time of prior immunotherapy; Prior to screening in this study, all AEs at the time of previous immunotherapy had not been completely remission or remission to grade 1; Subjects need to use other immunosuppressants other than glucocorticoids systematically to treat irAE.
  • History of severe hypersensitivity reactions to other mAbs.
  • History of organ transplantation.
  • Known allergy or reaction to any component of the investigational product formulation.
  • Receipt any anticancer therapy targeting the CD47/SIRPα signaling axis.
  • Known history of mental illness, alcohol or drug abuse.
  • Existing uncontrolled comorbiditions; Or a mental illness/social condition that may limit the subject's compliance with study requirements or affect the subject's ability to provide written informed consent.
  • Other exclusion criteria for subjects with lymphoma:History of HTLV-1 infection.Subjects with primary or secondary central nervous system lymphoma. Subjects with history of allogeneic hematopoietic stem cell transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • FuDan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Multicenter, Phase 1, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 in Subjects With Advanced Solid Tumors or Lymphomas

This is a multicenter, open label, single arm, Phase 1，dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacodynamics, PK, immunogenicity, and preliminary antitumor activity of AK117 administered intravenously to adult subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas.

Read the detailed description

The study comprises a dose escalation phase and a dose expansion phase. The phases will be conducted sequentially. Approximately 162 subjects will be enrolled in this study.

Being tested
AK117
Keywords
Antineoplastic Agents, Immunological
Medical subject headings
Neoplasms

What participants receive

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

  • AK117Drug

    An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal

Study groups in NCT04728334
Study groupRoleWhat they receive
AK117 monotherapyExperimentalAK117 monotherapy intravenous (IV) infusion - Weekly doses
Receives: Drug: AK117

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 time of informed consent signed through 30 days after the last dose of AK117

  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 relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications .

    Measured: During the first 21 days

Secondary outcomes (5)

  1. Objective response rate (ORR)

    ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by Investigator per RECIST Version 1.1 for solid tumor or the Lugano 2014 Classification for lymphoma

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD .

    Measured: Up to 2 years

  3. Maximum observed concentration (Cmax) of AK117

    The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.

    Measured: From first dose of AK117 through to 30 days after last dose of AK117

  4. Minimum observed concentration (Cmin) of AK117 at steady state

    The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.

    Measured: From first dose of AK117 through to 30 days after last dose of AK117

  5. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK117 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

    Measured: From first dose of AK117 through to 30 days after last dose of AK117

Timeline

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

  1. First posted28 Jan 2021
  2. Study start23 Mar 2021
  3. Primary completion25 Jan 2022
  4. Study completion12 May 2023

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
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04728334
Sponsor's protocol ID
AK117-102
Status last verified
Feb 2025
First submitted
24 Jan 2021
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
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 AK117 in people with Neoplasms Malignant, 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 10 inclusion and 25 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: finished, as of the sponsor's last update on 3 Mar 2025. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 time of informed consent signed through 30 days after the last dose of AK117). 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 NCT04728334.

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 3 Mar 2025.

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