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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK105 | Experimental | AK105 200 mg intravenously (IV) every-2-weeks (Q2W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK105 | Biological | AK105 200 mg intravenously (IV) every-2-weeks (Q2W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| 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. | From the time of informed consent signed through 90 days after the last dose of AK105 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Duration of Response (DoR) |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beiing | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35833116 | Derived | 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. |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.
| Up to 2 years |
| 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. | Up to 2 years |
| 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. | Up to 2 years |
| 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. | From first dose of AK105 through 30 days after last dose of AK105 |
| 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). | From first dose of AK105 through to 90 days after last dose of AK105 |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |