Non-small Cell Lung Cancer Stage IIIB/IVPhase 1/2NCT06943820
AK129 Combination Therapy for Advanced Solid Tumors
A Phase 1/2 study testing AK129(dose 1), Pemetrexed and Paclitaxel in people with Non-small Cell Lung Cancer Stage IIIB/IV and Head and Neck Squamous Cell Carcinoma (HNSCC), run by Akeso at 1 site in China.
Trial summary
This is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Adenocarcinoma
- What is being tested?
- AK129(dose 1), Pemetrexed and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2025to May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- ≥18 years old and ≤ 75 years (regardless of sex);
- ECOG performance status 0-1;
- Life expectancy longer than 3 months;
- 1)Histologically or cytologically confirmed diagnosis of Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;
- 1)Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (American Joint Committee on Cancer [AJCC]); 2)No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC ;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy;
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- Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization;
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- Adequate organ function.
Who cannot join
- Histologically or cytologically confirmed the presence of small cell carcinoma components/EGFR-sensitive mutations or ALK fusion positivite/known ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;
- Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable/mismatch repair gene expression defect (MSI-H/dMMR)or histopathological examination confirmed other pathological types;
- Participating in another clinical research;
- Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression;
- Has an active autoimmune disease that has required systemic treatment in the past 2 years;
- Has known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; known active syphilis infection; known active Hepatitis B or Hepatitis C;
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- Past or currently has non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid therapy;
- Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;
- Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;
- Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;
- Pregnant or lactating female.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongxu Liu,M.D. contact
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
About this study
Official title: A Phase Ib/II Study of Anti-PD-1/LAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors
This is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.
- Conditions
- Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Adenocarcinoma, Advanced Solid Tumors
- Being tested
- AK129(dose 1), Pemetrexed, Paclitaxel, Carboplatin, AK129(dose 2)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK129(dose 1)Drug
IV infusion
PemetrexedDrug
IV infusion;500mg/m2
PaclitaxelDrug
IV infusion;175mg/m2
CarboplatinDrug
IV infusion;AUC 5
AK129(dose 2)Drug
IV infusion
DocetaxelDrug
IV infusion;75mg/m2
Cis-platinumDrug
IV infusion;100 mg/m2
5-FU (5-fluorouracil)Drug
IV infusion;1000 mg/m2
CetuximabDrug
IV infusion;400mg/m2/ 250mg/m2
PaclitaxelDrug
IV infusion;80mg/m2
DocetaxelDrug
IV infusion;35mg/m2
ChemotherapyDrug
IV infusion
AK129(RP2D)Drug
IV infusion
PenpulimabDrug
IV infusion;200mg
| Study group | Role | What they receive |
|---|---|---|
| AK129(dose 1) + Chemotherapy(Phase Ib) | Experimental | Non-Squamous NSCLC:Subjects receive AK129 (dose 1) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 1) plus Pemetrexed until progression.
Squamous NSCLC:Subjects receive AK129 (dose 1) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 1) until progression. Receives: Drug: AK129(dose 1); Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin |
| AK129(dose 2) + Chemotherapy(Phase Ib) | Experimental | Non-Squamous NSCLC:Subjects receive AK129 (dose 2) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 2) plus Pemetrexed until progression.
Squamous NSCLC:Subjects receive AK129(dose 2) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 2) until progression. Receives: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: AK129(dose 2) |
| Cohort 1 PARTA Treatment Group 1(Phase II) | Experimental | Non-Squamous NSCLC:Subjects receive AK129 (RP2D) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(RP2D) plus Pemetrexed until progression.
Squamous NSCLC:Subjects receive AK129(RP2D) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(RP2D) until progression. Receives: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: AK129(RP2D) |
| Cohort 1 PARTA Treatment Group 2(Phase II) | Active comparator | Non-Squamous NSCLC:Subjects receive Penpulimab plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab plus Pemetrexed until progression.
Squamous NSCLC:Subjects receive Penpulimab plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab until progression. Receives: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Penpulimab |
| Cohort 1 PARTB(Phase II) | Experimental | NSCLC:Subjects receive AK129(RP2D) plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression. Receives: Drug: Docetaxel; Drug: AK129(RP2D) |
| Cohort 2 PARTA(Phase II) | Experimental | HNSCC:Subjects receive AK129(RP2D,Day1) plus Carboplatin/Cis-platinum(Day1) and 5-FU(Day1-4) every 3-week cycle (Q3W) for 6 cycles followed by AK129(RP2D) until progression. Receives: Drug: Carboplatin; Drug: Cis-platinum; Drug: 5-FU (5-fluorouracil); Drug: AK129(RP2D) |
| Cohort 2 PARTB(Phase II) | Experimental | HNSCC:Subjects receive AK129(RP2D) plus 1 investigator-selected treatment protocol(Cetuximab/Paclitaxel/Docetaxel) on Day 1 of every 3-week cycle (Q3W) until progression, and are not allowed to choose a treatment they had already received. Receives: Drug: Cetuximab; Drug: Paclitaxel; Drug: Docetaxel; Drug: AK129(RP2D) |
| Cohort 3(Phase II) | Experimental | CRC:Subjects receive AK129(RP2D) until progression. Receives: Drug: AK129(RP2D) |
| Cohort 4(Phase II) | Experimental | Advanced solid tumors:Subjects receive AK129(RP2D)± chemotherapy until progression. Receives: Drug: Chemotherapy; Drug: AK129(RP2D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AEs) ,Clinically significant abnormal laboratory results
Frequency and severity of AEs and clinically significant abnormal laboratory results for all arms in phase Ib/II.
Measured: Up to approximately 2 years
Overall Response Rate (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) for all arms in phase II , based on RECIST v1.1.
Measured: Up to approximately 2 years
Secondary outcomes (8)
Overall Response Rate (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) for all arms in phase Ib, based on RECIST v1.1.
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
Evaluation of PFS based on RECIST v1.1.
Measured: Up to approximately 2 years
Overall survival (OS)
Evaluation of OS based on RECIST v1.1.
Measured: Up to approximately 2 years
Disease control rate (DCR)
Evaluation of DCR based on RECIST v1.1.
Measured: Up to approximately 2 years
Duration of Response (DoR)
Evaluation of DoR based on RECIST v1.1.
Measured: Up to approximately 2 years
Time to Response (TTR)
Evaluation of TTR based on RECIST v1.1.
Measured: Up to approximately 2 years
Pharmacokinetics (PK)
PK parameters: serum concentrations of AK129 at different point of time
Measured: Up to cycle 21(each cycle is 21 days)
Anti-Drug Antibodies(ADAs)
Number and percentage of patients 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 posted24 Apr 2025
- Study start21 May 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIB/IVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943820
- Sponsor's protocol ID
- AK129-201
- Status last verified
- May 2025
- First submitted
- 6 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Anti-PD-1/LAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06943820
- Acronym / sponsor ID
- AK129-201
- Conditions
- Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Adenocarcinoma, Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Apr 2025 (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 an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| AK129(dose 1) + Chemotherapy(Phase Ib) | Experimental | Drug: AK129(dose 1), Drug: Pemetrexed, Drug: Paclitaxel, Drug: CarboplatinNon-Squamous NSCLC:Subjects receive AK129 (dose 1) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 1) plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK129 (dose 1) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 1) until progression. |
| AK129(dose 2) + Chemotherapy(Phase Ib) | Experimental | Drug: Pemetrexed, Drug: Paclitaxel, Drug: Carboplatin, Drug: AK129(dose 2)Non-Squamous NSCLC:Subjects receive AK129 (dose 2) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 2) plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK129(dose 2) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 2) until progression. |
| Cohort 1 PARTA Treatment Group 1(Phase II) | Experimental | Drug: Pemetrexed, Drug: Paclitaxel, Drug: Carboplatin, Drug: AK129(RP2D)Non-Squamous NSCLC:Subjects receive AK129 (RP2D) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(RP2D) plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK129(RP2D) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(RP2D) until progression. |
| Cohort 1 PARTA Treatment Group 2(Phase II) | Active comparator | Drug: Pemetrexed, Drug: Paclitaxel, Drug: Carboplatin, Drug: PenpulimabNon-Squamous NSCLC:Subjects receive Penpulimab plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab plus Pemetrexed until progression. Squamous NSCLC:Subjects receive Penpulimab plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab until progression. |
| Cohort 1 PARTB(Phase II) | Experimental | Drug: Docetaxel, Drug: AK129(RP2D)NSCLC:Subjects receive AK129(RP2D) plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression. |
| Cohort 2 PARTA(Phase II) | Experimental | Drug: Carboplatin, Drug: Cis-platinum, Drug: 5-FU (5-fluorouracil), Drug: AK129(RP2D)HNSCC:Subjects receive AK129(RP2D,Day1) plus Carboplatin/Cis-platinum(Day1) and 5-FU(Day1-4) every 3-week cycle (Q3W) for 6 cycles followed by AK129(RP2D) until progression. |
| Cohort 2 PARTB(Phase II) | Experimental | Drug: Cetuximab, Drug: Paclitaxel, Drug: Docetaxel, Drug: AK129(RP2D)HNSCC:Subjects receive AK129(RP2D) plus 1 investigator-selected treatment protocol(Cetuximab/Paclitaxel/Docetaxel) on Day 1 of every 3-week cycle (Q3W) until progression, and are not allowed to choose a treatment they had already received. |
| Cohort 3(Phase II) | Experimental | Drug: AK129(RP2D)CRC:Subjects receive AK129(RP2D) until progression. |
| Cohort 4(Phase II) | Experimental | Drug: Chemotherapy, Drug: AK129(RP2D)Advanced solid tumors:Subjects receive AK129(RP2D)± chemotherapy until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- ≥18 years old and ≤ 75 years (regardless of sex);
- ECOG performance status 0-1;
- Life expectancy longer than 3 months;
- 1)Histologically or cytologically confirmed diagnosis of Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;
Key exclusion criteria (11 listed)
- Histologically or cytologically confirmed the presence of small cell carcinoma components/EGFR-sensitive mutations or ALK fusion positivite/known ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;
- Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable/mismatch repair gene expression defect (MSI-H/dMMR)or histopathological examination confirmed other pathological types;
- Participating in another clinical research;
- Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression;
- Has an active autoimmune disease that has required systemic treatment in the past 2 years;
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 |
|---|---|---|
| AK129(dose 1)IV infusion | Drug | AK129(dose 1) + Chemotherapy(Phase Ib) |
| PemetrexedIV infusion;500mg/m2 | Drug | AK129(dose 1) + Chemotherapy(Phase Ib), AK129(dose 2) + Chemotherapy(Phase Ib), Cohort 1 PARTA Treatment Group 1(Phase II), Cohort 1 PARTA Treatment Group 2(Phase II) |
| PaclitaxelIV infusion;175mg/m2 | Drug | AK129(dose 1) + Chemotherapy(Phase Ib), AK129(dose 2) + Chemotherapy(Phase Ib), Cohort 1 PARTA Treatment Group 1(Phase II), Cohort 1 PARTA Treatment Group 2(Phase II) |
| CarboplatinIV infusion;AUC 5 | Drug | AK129(dose 1) + Chemotherapy(Phase Ib), AK129(dose 2) + Chemotherapy(Phase Ib), Cohort 1 PARTA Treatment Group 1(Phase II), Cohort 1 PARTA Treatment Group 2(Phase II), Cohort 2 PARTA(Phase II) |
| AK129(dose 2)IV infusion | Drug | AK129(dose 2) + Chemotherapy(Phase Ib) |
| DocetaxelIV infusion;75mg/m2 | Drug | Cohort 1 PARTB(Phase II) |
| Cis-platinumIV infusion;100 mg/m2 | Drug | Cohort 2 PARTA(Phase II) |
| 5-FU (5-fluorouracil)IV infusion;1000 mg/m2 | Drug | Cohort 2 PARTA(Phase II) |
| CetuximabIV infusion;400mg/m2/ 250mg/m2 | Drug | Cohort 2 PARTB(Phase II) |
| PaclitaxelIV infusion;80mg/m2 | Drug | Cohort 2 PARTB(Phase II) |
| DocetaxelIV infusion;35mg/m2 | Drug | Cohort 2 PARTB(Phase II) |
| ChemotherapyIV infusion | Drug | Cohort 4(Phase II) |
| AK129(RP2D)IV infusion | Drug | Cohort 1 PARTA Treatment Group 1(Phase II), Cohort 1 PARTB(Phase II), Cohort 2 PARTA(Phase II), Cohort 2 PARTB(Phase II), Cohort 3(Phase II), Cohort 4(Phase II) |
| PenpulimabIV infusion;200mg | Drug | Cohort 1 PARTA Treatment Group 2(Phase II) |
Primary outcome
Frequency and severity of adverse events (AEs) ,Clinically significant abnormal laboratory results
Time frame: Up to approximately 2 years
Frequency and severity of AEs and clinically significant abnormal laboratory results for all arms in phase Ib/II.
Overall Response Rate (ORR)
Time frame: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) for all arms in phase II , based on RECIST v1.1.
8 secondary outcomes
Overall Response Rate (ORR)
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
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Time to Response (TTR)
Time frame: Up to approximately 2 years
Pharmacokinetics (PK)
Time frame: Up to cycle 21(each cycle is 21 days)
Anti-Drug Antibodies(ADAs)
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 3 Jun 2025.
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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.
Hongxu Liu,M.D. contact
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(dose 1), Pemetrexed and Paclitaxel in people with Non-small Cell Lung Cancer Stage IIIB/IV and Head and Neck Squamous Cell Carcinoma (HNSCC), 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 11 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 3 Jun 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,M.D. (+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?
Frequency and severity of adverse events (AEs) ,Clinically significant abnormal laboratory results (time frame: Up to approximately 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?
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 Jun 2025.