Advanced Solid TumorPhase 1/2NCT05142423
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing AK109+AK104 in people with Advanced Solid Tumor, run by Akeso at 1 site in China.
Trial summary
This is a multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AK109+AK104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to Apr 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and signed informed consent.
- Age ≥ 18 years and ≤ 75 years.
- ECOG Performance Status of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented, locally advanced or metastatic solid tumours (NSCLC, mCRC, HCC, GEJ, etc. ), for which standard therapy does not exist or has proven ineffective or intolerable.
- At least one radiographically measurable lesion per RECIST 1.1.
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- Tumor biopsy (during advanced stage) available.
- Adequate organ function.
- Female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.
Who cannot join
- Other documented active malignancies other than for this trial within 3 years.
- Participation in other clincial trials simultaneously.
- Use of systemic anti-tumor treatments with 4 weeks, non-specific immunomodulating agents within 2 weeks.
- Prior exposure to other T cell coregulatory proteins except for PD-1/PD-L1 inhibitors (apart from cohort B, i.e. treatment naive HCC patients).
- Current use corticosteroids/immunosuppressive agents, permanently discontinuation of study drug, or having any unresolved irAEs (≥grade 2) from prior PD-1/PD-L1 inhibitors treatment.
- Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
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- Uncontrolled pleural/pericardial or peritoneal effusion.
- History of hemorrhagic event need blood transfusion, invasive approaches to intervene, or hospitalization within 3 months, or having high risks of bleeding.
- Any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 months.
- Uncontrolled gastrointestinal diseases.
- Use of NSAIDs and anticoagulant agents within 7 days.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks.
- Severe or uncontrolled hypertension and cardiovascular/cerebrovascular diseases.
- Uncontrolled comorbidities need corticosteroids using.
- Active or prior autoimmune disease or history of immunodeficiency.
- History of interstitial lung disease.
- Known history of active tuberculosis (TB).
- Evidence of active infections including hepatitis B and C.
- Use of anti-infectious agents within 2 weeks.
- History of human immunodeficiency virus (HIV) infections.
- Active syphilis infections.
- Any unresolved toxicities (≥grade 2) from previous anti-cancer therapies.
- Mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First affliated hospital of Zhejiang University
Hangzhou, Zhejiang
Nong Xu, MD
About this study
Official title: An Open Label, Multi-center, Phase Ib/II Clinical Study of AK109 Combined With AK104 to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Advanced Solid Tumors
This is a multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .
- Conditions
- Advanced Solid Tumor
- Being tested
- AK109+AK104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK109+AK104Drug
It includes dose escalation and dose expansion stage. 6-12 patients will be enrolled in dose escalation stage for safety and efficacy. Then select specific dose of AK104 and AK109. Expand for the further safety and efficacy study.
| Study group | Role | What they receive |
|---|---|---|
| AK109+AK104 | Experimental | AK104: 10mg/kg (d1, q3w); AK109: 10mg/kg or 15mg/kg(d1, q3w) Receives: Drug: AK109+AK104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing dose-limiting toxicities(DLTs)
DLTs will be assessed during the first 21 days of treatment 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: Up to 21 days
Incidences and severity of AE
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: Up to 2 years
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.
Measured: Up to 2 years
Secondary outcomes (6)
Progression-free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) or death from any cause (whichever occurs first)
Measured: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
Measured: Up to 2 years
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
Time to response (TTR)
Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR, as determined by the investigator according to RECIST v1.1.
Measured: Up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: Up to 2 years
Correlation analysis of PD-L1 expression with efficacy
Characteristics of tumor tissue PD-L1 expression and exploratory analysis of correlation between PD-L1 expression status and efficacy.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start3 Nov 2021
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nong Xu, MD, Principal investigator, The First Affiliated Hospital of Medicine College, Zhejiang UniversityJianming Xu, MD, Principal investigator, The Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142423
- Sponsor's protocol ID
- AK109-102
- Status last verified
- Mar 2025
- First submitted
- 29 Oct 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center, Phase Ib/II Clinical Study of AK109 Combined With AK104 to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05142423
- Acronym / sponsor ID
- AK109-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Dec 2021 (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 multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK109+AK104 | Experimental | Drug: AK109+AK104AK104: 10mg/kg (d1, q3w); AK109: 10mg/kg or 15mg/kg(d1, q3w) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written and signed informed consent.
- Age ≥ 18 years and ≤ 75 years.
- ECOG Performance Status of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented, locally advanced or metastatic solid tumours (NSCLC, mCRC, HCC, GEJ, etc. ), for which standard therapy does not exist or has proven ineffective or intolerable.
Key exclusion criteria (23 listed)
- Other documented active malignancies other than for this trial within 3 years.
- Participation in other clincial trials simultaneously.
- Use of systemic anti-tumor treatments with 4 weeks, non-specific immunomodulating agents within 2 weeks.
- Prior exposure to other T cell coregulatory proteins except for PD-1/PD-L1 inhibitors (apart from cohort B, i.e. treatment naive HCC patients).
- Current use corticosteroids/immunosuppressive agents, permanently discontinuation of study drug, or having any unresolved irAEs (≥grade 2) from prior PD-1/PD-L1 inhibitors treatment.
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 |
|---|---|---|
| AK109+AK104It includes dose escalation and dose expansion stage. 6-12 patients will be enrolled in dose escalation stage for safety and efficacy. Then select specific dose of AK104 and AK109. Expand for the further safety and efficacy study. | Drug | AK109+AK104 |
Primary outcome
Number of subjects experiencing dose-limiting toxicities(DLTs)
Time frame: Up to 21 days
DLTs will be assessed during the first 21 days of treatment 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.
Incidences and severity of AE
Time frame: Up to 2 years
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.
Objective response rate (ORR)
Time frame: Up to 2 years
The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Time to response (TTR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Correlation analysis of PD-L1 expression with efficacy
Time frame: Up to 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 12 Mar 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.
Nong Xu, MD principal investigator
The First Affiliated Hospital of Medicine College, Zhejiang University
Jianming Xu, MD principal investigator
The Chinese PLA General Hospital
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 AK109+AK104 in people with Advanced Solid Tumor, 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 23 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 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?
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 Ting Liu, MD (+86 (0760) 8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing dose-limiting toxicities(DLTs) (time frame: Up to 21 days). 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 12 Mar 2025.