A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors
ConditionSolid Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.
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.
Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;
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
100 Participants
are divided into 1 treatment groupGroup A: AK138D1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Cmax and Cmin of AK138D1
AK138D1 serum drug concentrations in subjects at different time points after administration.
Time frame
Up to approximately 2 years2
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame
Up to approximately 2 years3
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 years4
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame
Up to approximately 2 years Source ClinicalTrials.gov