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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HDM2024
DrugADC drug targeting EGFR and HER3
Treatment groups
63 Participants
are divided into 1 treatment groupGroup A: HDM2024Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximal tolerance dose (MTD) of HDM2024
The MTD is defined as the dose level at which the estimated toxicity probability is closest to the target toxicity rate during the Dose-limiting toxicity (DLT) observation period of the dose escalation stage.
Time frame
DLT will be evaluated on 21 days of observation period2
Determination of the Recommended Phase 2 dose (RP2D)
Time frame
Approximately 1 years3
Incidence and severity of Treatment-Emergent Adverse Events
Incidence rates of adverse events (AE), serious adverse events (SAE)per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0.
Time frame
Approximately 1 yearsSecondary outcomes
1
Time to peak (Tmax) of HDM2024
Tmax of HDM2024, total antibody, and exatecan will be measured
Time frame
Approximately 1 years2
Half-life time (t1/2) of HDM2024
t1/2 of HDM2024, total antibody, and exatecan will be measured
Time frame
Approximately 1year3
Peak Plasma Concentration (Cmax) of HDM2024
Cmax of HDM2024, total antibody, and exatecan will be measured
Time frame
Approximately 1 year4
Area under the plasma concentration versus time curve (AUC) of HDM2024
AUC of HDM2024, total antibody, and exatecan will be measured
Time frame
approximately 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov