Phase
Condition
All Solid Tumors
Treatment
AK138D1
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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;
Subjects who have histologically or cytologically diagnosed locally advanced ormetastatic solid tumor, which Is refractory to or intolerant to standard treatment;
At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeatedaccurate measurement.
Adequate organ function.
Exclusion
Exclusion Criteria:
Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, includingantibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cellimmunotherapy (CAR-T), and others;
Concomitant participation in another clinical study, unless it is anon-interventional clinical study or the follow-up period of an interventionalstudy;
Presence of active central nervous system (CNS) metastases.
Patients with a history of non-infectious pneumonitis requiring systemiccorticosteroid therapy; a history of interstitial lung disease (ILD) (includingpulmonary fibrosis or radiation pneumonitis); currently suffering fromILD/pneumonitis or suspected of having such diseases based on imaging duringscreening;
Live vaccines or attenuated live vaccines administered within 4 weeks prior to thefirst dose, or planned to be administered during the study; use of inactivatedvaccines is allowed;
Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). ForHBsAg-positive subjects, anti-hepatitis B therapy is required during the study;subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above thelower limit of detection) is also an exclusion;
Known active pulmonary tuberculosis (TB); subjects with suspected active TB mustundergo appropriate clinical assessment to rule out the presence of active disease;
Active syphilis infection;
Subjects with known allergy to any component of any study drug; and with a historyof known severe hypersensitivity reactions to other monoclonal antibodies;
Other reasons for ineligibility as evaluated by the investigator.
Study Design
Study Description
Connect with a study center
Blacktown Hospital-Blacktwon Cancer and Haematology Centre
Blacktown, New South Wales 2148
AustraliaSite Not Available
Macquarie University
North Ryde, New South Wales 2109
AustraliaSite Not Available
ICON Cancer Centre South Brisbane
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria 3199
AustraliaActive - Recruiting
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