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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

HDM2017
Drug
Participants will be treated with HDM2017 intravenous infusion

Treatment groups

96 Participants

are divided into 1 treatment group

Group A: HDM2017Experimental treatment 1 intervention

Trial outcomes