Advanced Malignant Tumors
Conditions
Brief 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.
Interventions
DRUGAK130
IV infusion, specified dose on specified days.
Sponsors
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative. 2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. 3. Life expectancy ≥3 months. 4. 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. 5. Subject must have at least one measurable lesion according to RECIST Version1.1. 6. Adequate organ function.
Exclusion criteria
1. 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. 2. Receipt of any anti-TIGIT, anti-TGF-β treatment. 3. 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. 4. 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of participants with adverse events (AEs) | From time ICF is signed until 90 days after last dose of AK130 |
| Number of participants with DLTs | During the first four weeks of treatment with AK130 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 2 years | — |
| Overall survival (OS) | Up to approximately 2 years | — |
| Duration of Response (DOR) | Up to approximately 2 years | — |
| Time to response (TTR) | Up to approximately 2 years | — |
| Objective response rate (ORR) | Up to approximately 2 years | — |
| Minimum observed concentration(Cmin) of AK130 | From first dose of study drug through end of treatment (up to approximately 2 years) | The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration. |
| Area under the curve (AUC) of AK130 for assessment of pharmacokinetics | From first dose of study drug through end of treatment (up to approximately 2 years) | The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration. |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of study drug through 30 days after last dose of study drug | — |
| Maximum observed concentration (Cmax) of AK130 | From first dose of study drug through end of treatment (up to approximately 2 years) | The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration. |
| Disease control rate (DCR) | Up to approximately 2 years | — |
Countries
China
Outcome results
None listed