Advanced Malignant TumorsPhase 1NCT05653284
A Study of AK130 in Patients With Advanced Malignant Tumors
A Phase 1 study testing AK130 in people with Advanced Malignant Tumors, run by Akeso at 1 site in China.
Trial summary
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- AK130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2023to 30 May 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥3 months.
- Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- Subject must have at least one measurable lesion according to RECIST Version1.1.
- Adequate organ function.
Who cannot join
- Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
- Receipt of any anti-TIGIT, anti-TGF-β treatment.
- Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
- Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.
- History of organ transplant.
- Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.
Trial locations and contacts
1 site in 1 country.
China1 site
The Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AK130 (TIGIT/TGF-β Bifunctional Fusion Protein) in Patients With Advanced Malignant Tumors
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.
- Conditions
- Advanced Malignant Tumors
- Being tested
- AK130
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK130Drug
IV infusion, specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| AK130 | Experimental | Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met. Receives: Drug: AK130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of participants with adverse events (AEs)
Measured: From time ICF is signed until 90 days after last dose of AK130
Number of participants with DLTs
Measured: During the first four weeks of treatment with AK130
Secondary outcomes (10)
Objective response rate (ORR)
Measured: Up to approximately 2 years
Disease control rate (DCR)
Measured: Up to approximately 2 years
Progression-free survival (PFS)
Measured: Up to approximately 2 years
Overall survival (OS)
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Time to response (TTR)
Measured: Up to approximately 2 years
Maximum observed concentration (Cmax) of AK130
The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.
Measured: From first dose of study drug through end of treatment (up to approximately 2 years)
Minimum observed concentration(Cmin) of AK130
The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.
Measured: From first dose of study drug through end of treatment (up to approximately 2 years)
Area under the curve (AUC) of AK130 for assessment of pharmacokinetics
The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.
Measured: From first dose of study drug through end of treatment (up to approximately 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: From first dose of study drug through 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start9 Feb 2023
- Primary completion12 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinming Yu, Principal investigator, The Cancer Hospital Affiliated to Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653284
- Sponsor's protocol ID
- AK130-101
- Status last verified
- Aug 2024
- First submitted
- 25 Nov 2022
- Last updated
- 13 Aug 2024
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AK130 (TIGIT/TGF-β Bifunctional Fusion Protein) in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05653284
- Acronym / sponsor ID
- AK130-101
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 16 Dec 2022 (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.
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK130 | Experimental | Drug: AK130Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥3 months.
- Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- Subject must have at least one measurable lesion according to RECIST Version1.1.
Key exclusion criteria (7 listed)
- Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
- Receipt of any anti-TIGIT, anti-TGF-β treatment.
- Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
- Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.
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 |
|---|---|---|
| AK130IV infusion, specified dose on specified days. | Drug | AK130 |
Primary outcome
Incidence and severity of participants with adverse events (AEs)
Time frame: From time ICF is signed until 90 days after last dose of AK130
Number of participants with DLTs
Time frame: During the first four weeks of treatment with AK130
10 secondary outcomes
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
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
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Maximum observed concentration (Cmax) of AK130
Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Minimum observed concentration(Cmin) of AK130
Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Area under the curve (AUC) of AK130 for assessment of pharmacokinetics
Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drug through 30 days after last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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. This study is not recruiting at the moment.
Jinming Yu principal investigator
The Cancer Hospital Affiliated to Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK130 in people with Advanced Malignant Tumors, 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 6 inclusion and 7 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 13 Aug 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 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.
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?
Incidence and severity of participants with adverse events (AEs) (time frame: From time ICF is signed until 90 days after last dose of AK130). 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 13 Aug 2024.