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
Qualifiers
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
Treatments tested in this trial
- AK138D1
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov