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Hodgkin's LymphomaPhase 1/2NCT03722147

A Study of Anti-PD-1 AK105 in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma

A Phase 1/2 study testing AK105 in people with Hodgkin's Lymphoma, 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 single-arm, open-label, multicenter, phase I/II study to evaluate efficacy and safety of AK105 in patients with relapsed or refractory classic Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
AK105
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
13 Aug 2018to 31 Dec 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written and signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Histologically confirmed classic Hodgkin's lymphoma (cHL) (based on tumor tissue obtained within 3 years prior to enrollment).
  • Relapsed (disease progression during or after most recent therapy) or refractory (failure to achieve CR or PR after most recent therapy) cHL and meet any of the following criterions:
  • Recurrence or disease progression after autologous hematopoietic stem cell transplantation.
  • For subject without receiving , the subject has received at least 2 lines of prior systemic chemotherapy. Refractory subject is defined as subject who has not achieved PR after at least 2 cycles of treatment, or subject who has not achieved CR after at least 4 cycles of treatment. If the best response to treatment is PD or the reason for ending the treatment is PD, the subject is consider as refractory without requirement on the number of cycles of treatment that the subject has received. For relapsed subjects, disease progression occurred for the subject who has received at least 2 line of prior systemic chemotherapy.
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  • Subject must have at least one measurable lesion (> 1.5 cm in the longest diameter, or > 1 cm in the longest diameter with uptake on 18FDG-PET)according to the Lugano 2014 criteria.
  • Adequate organ functions.
  • Use effective methods of contraception.

Who cannot join

  • Known nodular lymphoma predominant Hodgkin lymphoma or Grey zone lymphoma.
  • Lymphoma involving the central nervous system.
  • Participated in other clinical studies of experimental drugs or received research treatment or used experimental equipment within 4 weeks prior to the first dose of AK105.
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
  • Receipt of the last radiotherapy or the last dose of anticancer therapy (chemotherapy, target therapy, immunotherapy or tumor embolism, etc.) with 4 weeks prior to the first dose of AK105. Receipt of the last dose of nitrocarbamide or mitomycin C within 6 weeks prior to the first dose of AK105.
  • Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTL4 antibody or any other antibody or drug targeting T-cell costimulation or checkpoint pathways such as ICOS, or agonists such as CD40, CD137, GITR, OX40 etc..
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  • Had other active malignancies within 5 years prior to enrollment. Locally curable cancer (manifested as cured) is excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
  • Active, known or suspected autoimmune diseases, or a history of the disease within the past 2 years, except the following: vitiligo, alopecia, Graves' disease, psoriasis or eczema that do not require systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring a stable dose of hormone replacement therapy, type I diabetes requiring only a stable dose of insulin replacement therapy, or diseases not expected to recur in the absence of external triggering factors.
  • Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis or chronic diarrhea).
  • Subjects 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.
  • History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • History of primary immunodeficiency.
  • History of active tuberculosis.
  • History of allogeneic stem cell transplantation or organ transplantation.
  • Autologous hematopoietic stem cell transplantation performed within 90 days prior to the first dose of AK105.
  • History of gastrointestinal perforation and /or within 6 months prior to enrollment.
  • History of interstitial lung disease.
  • Patients with untreated chronic hepatitis B or with HBV DNA exceeding 500 IU/mL, or with active hepatitis C should be excluded. Inactive HBsAg carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), or cured hepatitis C patients can be enrolled. For patients with positive HCV antibody, they are eligible to participate in the study only if the test result of HCV RNA is negative.
  • Major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of AK105 or still recovering from prior surgery. Local procedures (eg, placement of a systemic port, core needle biopsy, and prostate biopsy) are allowed if completed at least 24 hours prior to the administration of the first dose of study treatment.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Active infections requiring systemic treatment.
  • Uncontrolled concurrent disease, including but not limited to, persistent or active infection, symptomatic congestive heart failure (according to the New York heart association functional class defined 3 or 4), out of control of high blood pressure, unstable angina, arrhythmia, severe peptic ulcer or gastritis, activity, or mental illness/social status which will limit the participants compliance requirements or damage to the participants to provide written informed consent.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) (NCI CTCAE v4.03) Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the study drug may be included (eg, hearing loss) after consultation with the medical monitor. Subjects with ≤ Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the medical monitor.
  • Receipt of live or attenuated vaccination within 30 days prior to the first dose of AK105, or plan to have live or attenuated vaccination during the study.
  • Known allergy or reaction to any component of the AK105 formulation.
  • History of severe allergic reaction to any other monoclonal antibodies.
  • Women who are pregnant or nursing.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beiing, 100142

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Open-label, Phase I/II Study of AK105 as Monotherapy in Relapsed or Refractory Classic Hodgkin Lymphoma

This is a single-arm, open-label, multicenter, phase I/II study to evaluate efficacy and safety of AK105 in patients with relapsed or refractory classic Hodgkin lymphoma.

Being tested
AK105
Keywords
immunotherapy, immuno-oncology, Classic Hodgkin Lymphoma
Medical subject headings
Hodgkin Disease

What participants receive

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

  • AK105Biological

    AK105 200 mg intravenously (IV) every-2-weeks (Q2W)

Study groups in NCT03722147
Study groupRoleWhat they receive
AK105ExperimentalAK105 200 mg intravenously (IV) every-2-weeks (Q2W)
Receives: Biological: AK105

What is being measured

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

  1. Objective response rate (ORR) assessed by Independent Radiology Review Committee (IRRC) per the Lugano 2014 Classification

    ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by IRRC per the Lugano 2014 Classification.

    Measured: Up to 2 years

  2. Number of subjects 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 90 days after the last dose of AK105

Secondary outcomes (6)

  1. ORR assessed by Investigator

    ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by Investigator per the Lugano 2014 Classification.

    Measured: Up to 2 years

  2. Duration of Response (DoR)

    From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.

    Measured: Up to 2 years

  3. Progression-free Survival (PFS)

    From the first dose of AK105 to the date of the date of objective disease progression or death, whichever occurs first.

    Measured: Up to 2 years

  4. Disease control rate (DCR)

    DCR defined as the proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) per the Lugano 2014 Classification.

    Measured: Up to 2 years

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

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

    Measured: From first dose of AK105 through 30 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 antidrug 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 posted26 Oct 2018
  2. Study start13 Aug 2018
  3. Primary completion10 Jan 2020
  4. Study completion31 Dec 2021

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
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03722147
Sponsor's protocol ID
AK105-201
Status last verified
Apr 2024
First submitted
25 Oct 2018
Last updated
3 Apr 2024
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK105 in people with Hodgkin's Lymphoma, 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 9 inclusion and 28 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 Apr 2024. 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) assessed by Independent Radiology Review Committee (IRRC) per the Lugano 2014 Classification (time frame: Up to 2 years). 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 NCT03722147, which also lists 1 linked publication.

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 Apr 2024.

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