A Study of AK157D1 for Injection in Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able to understand and voluntarily sign the written informed consent form.
Aged of ≥ 18 years and ≤75 years.
Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
At least one measurable lesion according to RECIST v1.1.
Disqualifiers
Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
Having other active malignancies within 3 years.
Having received major surgical operations within 4 weeks before the first administration.
Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
Trial design
Design model
Sequential
Treatments tested in this trial
AK157D1 for injection
DrugIV infusion, administered on Day 1 of each cycle, Q3W, continuous treatment
Treatment groups
243 Participants
are divided into 1 treatment groupGroup A: AK157D1 for injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with dose limiting toxicities (DLTs)
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Time frame
During the first 3 weeks of treatment.2
Number of participants with adverse events (AEs)
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
Time frame
From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.Secondary outcomes
1
Area under curve (AUC)
The area under the curve of the drug concentration in the blood over time
Time frame
From pre-dose to the end of the last dose, an average of 6 months.2
Maximum Concentration (Cmax)
The peak value of the plasma drug concentration reached on the time curve after a single administration
Time frame
From pre-dose to the end of the last dose, an average of 6 months.3
Peak Time (Tmax)
The time required for the drug concentration in human plasma to reach its peak (peak concentration) after administration
Time frame
From pre-dose to the end of the last dose, an average of 6 months.4
The terminal elimination half-life (t1/2)
The time that takes for the elimination processes to reduce the plasma concentration of the drug in the body by 50%
Time frame
From pre-dose to the end of the last dose, an average of 6 months. Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: