Phase
Condition
Solid Tumors
Treatment
HDM2017
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be able and willing to provide written informed consent.
Male or female participants aged 18 to 75 years.
Participants with histologically or cytologically confirmed locally advancedunresectable or metastatic malignant solid tumors who have failed adequate standardof care, or are intolerant to standard of care, or have no effective standardtreatment options.
Be able to provide archived tumor tissue during the screening period.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Life expectancy ≥3 months.
According to RECIST v1.1, participants must have at least one measurable lesion.
Has adequate organ function.
All subjects of reproductive potential must agree to use an effective method ofcontraception, as determined by the Investigator, during and for 7 months after thelast dose of study treatment.
Be willing and able to complete regular visits, treatment plans, laboratory tests,and other trial procedures.
Exclusion
Exclusion Criteria:
Participants who have previously received ADC therapy containing Top I inhibitors,or other drug therapy targeting the CDH17 target.
Participants who have received the following treatments:
Participants who have undergone major surgery within 4 weeks before the firstdose;
Participants who have received radiotherapy involving the bone marrow orextensive radiotherapy within 4 weeks before the first dose; or localradiotherapy within 2 weeks before the first dose;
Participants receiving continuous systemic corticosteroid therapy;
Participants who have received systemic antitumor therapy, or any otherinvestigational drug therapy within 4 weeks or 5 half-lives (whichever isshorter; at least 2 weeks) before the first dose.
Participants with other malignant tumors within the past 5 years, other than thetumor being treated in this study, with the exception of locally cured tumors (suchas basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladdercancer, carcinoma in situ of the cervix or breast).
Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy)have not recovered to ≤Grade 1 or baseline level.
Known weight loss of >10% within 2 months before the first dose of study drug orother indicators showing severe malnutrition.
History of gastrointestinal perforation, abdominal fistula, or extensive intestinalresection within 6 months before the first dose; complete or incompletegastrointestinal obstruction or intra-abdominal abscess within 3 months before thefirst dose.
History of gastrointestinal hemorrhage within 3 months before the first dose, or aclear gastrointestinal hemorrhagic diathesis.
Participants with known active CNS metastasis.
Participants with cardiovascular/cerebrovascular disorder, symptoms, ormanifestations.
Participants with active syphilis, history of human immunodeficiency virus (HIV)infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), exceptfor asymptomatic chronic hepatitis B or C virus carriers.
Study Design
Connect with a study center
Peking University Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349
ChinaActive - Recruiting

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