A Phase 1 Study of HDM2017 in Advanced Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
This is a phase I clinical study. All subjects are patients with advanced solid tumors. The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary antitumor efficacy of HDM2017 in patients with advanced malignant solid tumors.
Eligibility criteria
Qualifiers
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 advanced unresectable or metastatic malignant solid tumors who have failed adequate standard of care, or are intolerant to standard of care, or have no effective standard treatment options.
Be able to provide archived tumor tissue during the screening period.
Disqualifiers
Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
Participants who have undergone major surgery within 4 weeks before the first dose;
Participants who have received radiotherapy involving the bone marrow or extensive radiotherapy within 4 weeks before the first dose; or local radiotherapy within 2 weeks before the first dose;
Participants receiving continuous systemic corticosteroid therapy;
Trial design
Treatments tested in this trial
- HDM2017
Treatment groups
96 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov