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Solid TumorPhase 1/2NCT04172506

A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors

A Phase 1/2 study testing AK105 in people with Solid Tumor and Lung Cancer, 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 multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor, Lung Cancer, HCC
What is being tested?
AK105
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
10 Sep 2019to 30 Jan 2022
Phase
Phase 1/2
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

  • Written and signed informed consent.
  • Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male.
  • ECOG PS is 0-1.
  • The expected survival time is ≥ 3months
  • Histologically or cytologically confirmed selected advanced solid tumor.
  • Subject must have at least one measurable lesion according to RECIST Version1.1.
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  • Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy.
  • Adequate organ function.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
  • Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
  • Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other requirements for the study.

Who cannot join

  • Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug.
  • Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study drug.
  • Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.).
  • Toxicity from previous anti-cancer therapy has not been alleviated or resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria.
  • Patients with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
  • Active or previously recorded inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).
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  • Patients with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Large surgical procedures (defined by researchers as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first dose of study drug.
  • Known history of interstitial lung disease.
  • Patients with untreated chronic hepatitis B or HBV DNA exceeding 1000IU/mL or active hepatitis C. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
  • Patients with active tuberculosis (TB).
  • History of known primary immunodeficiency virus infection or positive HIV testing.
  • Severe infections within 4 weeks prior to the first dose of study drug, including but not limited to complications, sepsis or severe pulmonary infections requiring hospitalization.
  • Patients with meningeal metastasis, spinal cord compression, pia mater disease or active brain metastasis. Patients who meet one of the following requirements may be enrolled: a). No central nervous system metastasis symptoms and signs, such as neurological dysfunction, epilepsy or other central nervous system metastasis before admission. No edema around the lesion found by imaging examination, and no brain metastasis more than 1.5 cm in length. b). Patients with central nervous system metastasis had received treatment and achieved asymptomatic status (e.g. without neurological dysfunction, epilepsy or other typical central nervous system metastasis symptoms and signs)
  • Patients with pleural effusion, pericardial effusion or ascites that could not be controlled stably by repeated drainage or other methods as judged by the investigator.
  • Receipt of live, attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live, attenuated vaccine during the study.
  • Known history of sever hypersensitivity reaction to other monoclonal antibodies.
  • Known history of allergy or hypersensitivity to AK105 or any of its components
  • Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors

This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors.

Being tested
AK105
Keywords
Anti-PD-1, immunotherapy
Medical subject headings
Lung Neoplasms

What participants receive

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

  • AK105Drug

    Anti-PD-1 antibody

Study groups in NCT04172506
Study groupRoleWhat they receive
AK105ExperimentalAK105 200 mg, every 2 weeks
Receives: Drug: AK105

What is being measured

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

  1. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: Up to 2 years

Secondary outcomes (6)

  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: the time of informed consent signed through 90 days after the last dose of AK105

  2. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

    Measured: Up to 2 years

  3. Duration of response (DoR)

    Duration of response 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

  4. Progression-free survival (PFS)

    Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  5. Minimum observed concentration (Cmin) of AK105 at steady state

    The endpoints for assessment of PK of AK104 include serum concentrations of AK105 at different timepoints after AK105 administration.

    Measured: From first dose of AK105 through to 90 days after last dose of AK105

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

    The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: From first dose of AK105 through to 90 days after last dose of AK105

Timeline

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

  1. First posted21 Nov 2019
  2. Study start10 Sep 2019
  3. Primary completion1 Dec 2021
  4. Study completion30 Jan 2022

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172506
Sponsor's protocol ID
AK105-204
Status last verified
Mar 2025
First submitted
19 Nov 2019
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022.

    PubMed 35833116

  • Zheng Y, Mislang ARA, Coward J, Cosman R, Cooper A, Underhill C, Zhu J, Xiong J, Jiang O, Wang H, Xie Y, Zhou Y, Jin X, Li B, Wang ZM, Kwek KY, Xia D, Xia Y, Xu N. Penpulimab, an anti-PD1 IgG1 antibody in the treatment of advanced or metastatic upper gastrointestinal cancers. Cancer Immunol Immunother. 2022 Oct;71(10):2371-2379. doi: 10.1007/s00262-022-03160-1. Epub 2022 Feb 15.

    PubMed 35165764

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK105 in people with Solid Tumor and Lung Cancer, 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 11 inclusion and 20 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 12 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 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?

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?

Objective response rate (ORR) (time frame: Up to 2 years). 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 NCT04172506, which also lists 2 linked publications.

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 12 Mar 2025.

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