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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
HDM2012
DrugHDM2012 will be administered via IV infusion.
Treatment groups
129 Participants
are divided into 1 treatment groupGroup A: HDM2012Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Time frame
up to 21 days following first dose2
Incidence and severity of adverse events(for dose escalation phase)
The safety profile of HDM2012 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame
Until 30 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first3
Objective Response Rate (ORR) (for dose expansion phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame
through study completion, an average of 1 year4
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, E-R relationships, and efficacy data.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Plasma concentration of HDM2012
Plasma concentration of HDM2012
Time frame
up to7 days following last dose2
Immunogenicity
Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
Time frame
up to 7 days following last dose3
Incidence and severity of adverse events(for dose expansion phase)
The safety profile of HDM2012 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame
Until 30 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first4
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov