Advanced Malignant Tumors
Conditions
Brief summary
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.
Interventions
DRUGAK137
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. 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-CD73, anti-LAG-3 treatment. 3. Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required. 4. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs | From time ICF is signed until 90 days after last dose of AK137 | Incidence and severity of participants with adverse events |
| DLT | During the first 28-day of treatment with AK137 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DoR) | Up to approximately 2 years |
| Time to response (TTR) | Up to approximately 2 years |
| Progression Free Survival (PFS) | Up to approximately 2 years |
| Objective Response Rate (ORR) | Up to approximately 2 years |
| Cmax of AK137 | From first dose of study drug through end of treatment (up to approximately 2 years) |
| Cmin of AK137 | 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) | From first dose of study drug through 30 days after last dose of study drug |
| Overall Survival (OS) | Up to approximately 2 years |
| Disease Control Rate (DCR) | Up to approximately 2 years |
Countries
China
Contacts
Primary ContactXufang Yu
Outcome results
None listed