Classic Hodgkin LymphomaPhase 1/2NCT06642792
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
A Phase 1/2 study testing AK129 and AK117 in people with Classic Hodgkin Lymphoma, run by Akeso at 1 site in China.
Trial summary
This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Hodgkin Lymphoma
- What is being tested?
- AK129 and AK117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old at the time of enrolment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected Survival of ≥ 12 weeks.
- Diagnosed as R/R cHL according to Lugano 2014 criteria.
- Has progressed on treatment with PD-1/L1 inhibitior therapy.
- Has adequate organ function.
- All female and male subjects of reproductive potential must agree to use an effective method of contraception from the start of screening until 120 days after the last dose of study treatment.
Who cannot join
- Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zone lymphoma.
- Central nervous system (CNS) lymphoma involvement.
- Known history of human T-cell leukemia virus type 1 (HTLV-1) infection.
- Autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose of study treatment.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Previous use of any agents targeting the CD47-SIRPα pathway, LAG-3 pathway, or similar targets.
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- Has other malignancies within 3 years prior to the first dose or residual lesions from other malignancies diagnosed more than 3 years ago.
- Has an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
- History of active or previously confirmed inflammatory bowel disease.
- History of interstitial lung disease requiring corticosteroid therapy, or current interstitial lung disease.
- Has known active Hepatitis B or Hepatitis C.
- Unresolved toxicity from previous anti-tumor treatment.
- Uncontrolled comorbidities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Study of AK129 (Bispecific Antibody Targeting LAG-3 and PD-1) Monotherapy or in Combination With AK117 (Anti-CD47 Monoclonal Antibody) in Relapse or Refractory Classic Hodgkin Lymphoma With PD-1/L1 Inhibitor Treatment Failure
This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy. The purpose of this study is to evaluate the safety and efficacy of AK129 (bispecific antibody targeting LAG-3 and PD-1) monotherapy or in combination with AK117 (anti-CD47 monoclonal antibody) in R/R cHL with PD-1/L1 inhibitor treatment failure.
- Conditions
- Classic Hodgkin Lymphoma
- Being tested
- AK129, AK117
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK129Drug
Subjects receive AK129 intravenously.
AK117Drug
Subjects receive AK117 intravenously.
| Study group | Role | What they receive |
|---|---|---|
| AK129 | Experimental | Phase Ia: Subjects will receive AK129: different doses on every 2 weeks. Receives: Drug: AK129 |
| AK129+AK117 | Experimental | Phase Ib: Subjects will receive: AK129: different doses on every 2 weeks, AK117: 30mg/kg on every 2 weeks.
Phase II: Subjects will receive: AK129: recommended phase II dose (RP2D) from phase Ib on every 2 weeks, AK117: 30mg/kg on every 2 weeks. Receives: Drug: AK129; Drug: AK117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Number of participants with dose limiting toxicity (DLT)
Any untoward medical occurrence in a subject within the first 28 days following the first dose, considered related to the study treatment.
Measured: Within the first 28 days following the first dose of study treatment.
Phase I/II: Incidence and severity of adverse events (AEs)
Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to approximately 2 years.
Phase I/II: Objective response rate (ORR)
The proportion of subjects achieving complete response (CR) or partial response (PR) assessed by investigator per Lugano 2014 criteria.
Measured: Up to approximately 2 years
Secondary outcomes (10)
Disease control rate (DCR)
The proportion of subjects achieving complete response (CR) , partial response (PR) or stable disease (SD) assessed by investigator per Lugano 2014 criteria.
Measured: Up to approximately 2 years
Time to response (TTR)
The time from cycle 1 day 1(C1D1) to the first recorded response assessed by investigator per Lugano 2014 criteria.
Measured: Up to approximately 2 years
Duration of response (DoR)
The time from the first recorded response until disease progression assessed by investigator or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Progression-free survival (PFS)
The time from C1D1 until disease progression assessed by investigator or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Overall survival (OS)
The time from C1D1 until death due to any cause.
Measured: Up to approximately 2 years
Maximum concentration (Cmax)
The maximum concentration of the drug observed in the blood plasma after administration.
Measured: Up to approximately 2 years
Time to maximum concentration (Tmax)
The time taken to reach the maximum concentration (Cmax) of the drug in the blood plasma.
Measured: Up to approximately 2 years
Area under the curve (AUC)
The area under the plasma concentration versus time curve, which represents the total drug exposure over time.
Measured: Up to approximately 2 years
Half-life (T1/2)
The time required for the plasma concentration of the drug to decrease by half.
Measured: Up to approximately 2 years
Anti-drug antibody (ADA)
Number of subjects with detectable anti-drug antibodies.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start17 Jan 2025
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenting Li, MD, Study director, Akeso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642792
- Sponsor's protocol ID
- AK129-102
- Status last verified
- Feb 2025
- First submitted
- 26 Sep 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of AK129 (Bispecific Antibody Targeting LAG-3 and PD-1) Monotherapy or in Combination With AK117 (Anti-CD47 Monoclonal Antibody) in Relapse or Refractory Classic Hodgkin Lymphoma With PD-1/L1 Inhibitor Treatment Failure
- ClinicalTrials.gov ID
- NCT06642792
- Acronym / sponsor ID
- AK129-102
- Conditions
- Classic Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy. The purpose of this study is to evaluate the safety and efficacy of AK129 (bispecific antibody targeting LAG-3 and PD-1) monotherapy or in combination with AK117 (anti-CD47 monoclonal antibody) in R/R cHL with PD-1/L1 inhibitor treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK129 | Experimental | Drug: AK129Phase Ia: Subjects will receive AK129: different doses on every 2 weeks. |
| AK129+AK117 | Experimental | Drug: AK129, Drug: AK117Phase Ib: Subjects will receive: AK129: different doses on every 2 weeks, AK117: 30mg/kg on every 2 weeks. Phase II: Subjects will receive: AK129: recommended phase II dose (RP2D) from phase Ib on every 2 weeks, AK117: 30mg/kg on every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old at the time of enrolment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected Survival of ≥ 12 weeks.
- Diagnosed as R/R cHL according to Lugano 2014 criteria.
- Has progressed on treatment with PD-1/L1 inhibitior therapy.
Key exclusion criteria (13 listed)
- Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zone lymphoma.
- Central nervous system (CNS) lymphoma involvement.
- Known history of human T-cell leukemia virus type 1 (HTLV-1) infection.
- Autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose of study treatment.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK129Subjects receive AK129 intravenously. | Drug | AK129, AK129+AK117 |
| AK117Subjects receive AK117 intravenously. | Drug | AK129+AK117 |
Primary outcome
Phase I: Number of participants with dose limiting toxicity (DLT)
Time frame: Within the first 28 days following the first dose of study treatment.
Any untoward medical occurrence in a subject within the first 28 days following the first dose, considered related to the study treatment.
Phase I/II: Incidence and severity of adverse events (AEs)
Time frame: Up to approximately 2 years.
Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Phase I/II: Objective response rate (ORR)
Time frame: Up to approximately 2 years
The proportion of subjects achieving complete response (CR) or partial response (PR) assessed by investigator per Lugano 2014 criteria.
10 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Maximum concentration (Cmax)
Time frame: Up to approximately 2 years
Time to maximum concentration (Tmax)
Time frame: Up to approximately 2 years
Area under the curve (AUC)
Time frame: Up to approximately 2 years
Half-life (T1/2)
Time frame: Up to approximately 2 years
Anti-drug antibody (ADA)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenting Li, MD study director
Akeso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK129 and AK117 in people with Classic Hodgkin 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li, MD (+86(0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Number of participants with dose limiting toxicity (DLT) (time frame: Within the first 28 days following the first dose of study treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.