A Study of AK138D1 in Advanced Malignant Tumors
ConditionSolid Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject must sign the written informed consent form (ICF) voluntarily;
At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
ECOG performance status score of 0 or 1;
Has a life expectancy of ≥ 3 months;
Disqualifiers
Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
Presence of active central nervous system (CNS) metastases.
Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
Trial design
Design model
Single group
Treatments tested in this trial
AK138D1
DrugEnrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: AK138D1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
Incidence and severity of participants with adverse events
Time frame
Up to approximately 2 years2
Dose-Limiting Toxicity (DLT)
Occurrence of DLTs and determination fo maximum tolerated dose (MTD)
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Peak Plasma Concentration (Cmax) of AK138D1
AK138D1 serum drug concentrations in subjects at different time points after administration.
Time frame
Up to approximately 2 years2
Area under the plasma concentration versus time curve (AUC) of AK138D1
The definite integral of the concentration of AK138D1 in blood plasma as a function of time.
Time frame
Up to approximately 2 years3
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame
Up to approximately 2 years4
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Time frame
Up to approximately 2 years Source ClinicalTrials.gov