A Study of HDM2012 in Patients With Advanced Solid Tumor
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2012 in patients with advanced solid tumors.
Eligibility criteria
Qualifiers
The participants understand and voluntarily (or their legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Males or females aged ≥18 years and less than or equal to 75 years.
For escalation cohorts in the dose escalation phase: subjects must have histologically or cytologically confirmed advanced or metastatic malignant solid tumors, who have been previously treated and failed after adequate standard therapy, and have no standard treatment options available that have the potential to confer clinical benefit, including but not limited to gastric cancer (including esophagogastric junction adenocarcinoma), colorectal cancer, pancreatic cancer, etc.
For backfill cohorts in the dose escalation phase and the dose expansion phase: subjects must have histologically or cytologically confirmed advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) or colorectal cancer.
Disqualifiers
Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors.
Major surgery within 4 weeks prior to first dose, except minor procedures such as appendectomy, tumor biopsy, etc.;
Radiation therapy to bone marrow (equivalent to pelvic marrow area) or extensive radiation within 4 weeks prior to first dose; local radiotherapy (e.g., thoracic vertebrae and rib radiation) within 2 weeks prior to first dose;
Continuous systemic corticosteroid administration (>10 mg/day prednisone equivalent) within 2 weeks prior to first dose; low-dose corticosteroids (≤10 mg/day prednisone equivalent) are permitted if dose has been stable for 4 weeks;
Trial design
Treatments tested in this trial
- HDM2012
Treatment groups
129 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov