A Study of HDM2024 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:
* Is the drug safe and tolerable ? * Does the drug exhibit antitumor activity ?
Participants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.
Eligibility criteria
Qualifiers
1. Participants who voluntarily participate in this study and sign the written Informed Consent Form (ICF) after being fully informed.
2. Male or female participants aged 18 to 75 years (inclusive).
3. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors who have experienced disease progression on or after standard therapy , or are intolerant to standard therapy, or for whom no effective standard of care is available.
4. Participants who are able to provide fresh or archival tumor tissue during the screening period. Tumor tissue will be collected for biomarker testing at a central laboratory, including immunohistochemistry for EGFR and HER3 .
Disqualifiers
1. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and/or HER3.
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 who are receiving continuous systemic corticosteroid therapy ; low-dose corticosteroids are permitted if the dose of systemic corticosteroids has been stable for 4 weeks;
Trial design
Treatments tested in this trial
- HDM2024
Treatment groups
63 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov