AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors
ConditionAdvanced Malignant Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written and signed informed consent.
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.
Disqualifiers
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-CD73, anti-LAG-3 treatment.
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.
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/exclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
Trial design
Design model
Single group
Treatments tested in this trial
AK137
DrugIV infusion, specified dose on specified days.
Treatment groups
87 Participants
are divided into 1 treatment groupGroup A: AK137Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AEs
Incidence and severity of participants with adverse events
Time frame
From time ICF is signed until 90 days after last dose of AK1372
DLT
Time frame
During the first 28-day of treatment with AK137Secondary outcomes
1
Objective Response Rate (ORR)
Time frame
Up to approximately 2 years2
Disease Control Rate (DCR)
Time frame
Up to approximately 2 years3
Duration of Response (DoR)
Time frame
Up to approximately 2 years4
Time to response (TTR)
Time frame
Up to approximately 2 years Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: