A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor
ConditionAdvanced Malignant Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be able to understand and voluntarily sign the written informed consent form.
Aged of ≥ 18 years and ≤75 years.
ECOG PS 0 or 1.
The expected lifespan is ≥3 months.
Disqualifiers
Having other active malignancies within 3 years.
Currently participating in another interventional clinical study.
Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
Having received any treatment targeting CSF-1R, ILT2 and ILT4..
Trial design
Design model
Single group
Treatments tested in this trial
AK150
DrugIV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment
Treatment groups
96 Participants
are divided into 1 treatment groupGroup A: AK150Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with a Dose Limiting Toxicity (DLT)
DLTs will be assessed during the first 4 weeks of treatment for dose-escalation I phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 2 cycles (4 weeks) of treatment
Time frame
During the first 4 weeks2
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame
From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.Secondary outcomes
1
Serum PK concentration of AK150
Serum PK of AK150 at different timepoints after AK150 administration
Time frame
From pre-dose to the end of the last dose, an average of 6 months.2
The immunogenicity of AK150
The immunogenicity of AK150 will be assessed by summarizing the number of participants who develop detectable anti-drug antibodies (ADAs)
Time frame
From pre-dose to 30 days post end of treatment3
Overall response rate (ORR)
Efficacy measures such as ORR, which is the proportion of participants with CR or PR by investigator based on RECIST v1.1
Time frame
Up to 12 year.4
Progression-Free Survival(PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
Time frame
Up to 1 year Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: