NCT07539285
Recruiting
Phase 1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Efficacy of HDM2024 in Participants With Advanced Solid Tumors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.1 site in 1 country63 target enrollmentStarted: April 10, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Maximal tolerance dose (MTD) of HDM2024
Overview
Brief Summary
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.
Detailed Description
Target population are patients with advanced solid tumors .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 .
- •5\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 .
- •6\. Life expectancy ≥3 months.
- •7\. According to RECIST v1.1, the participant must have at least one measurable lesion .
- •8\. Participants with good organ function as demonstrated by screening laboratory test results.
- •9\. The fertile participants agreed to take effective contraceptive measures during the study and after its conclusion; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before dosing.
- •10\. Participants should be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria
- •1\. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and/or HER
- •2\. Participants who have received the following treatments:
- •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;
- •Participants who have received anti-tumor treatments within 4 weeks before the first dose, or are still within 5 half-lives of the last dose of the most recent anticancer therapy (whichever is longer). Traditional Chinese medicines with approved anticancer indications within 2 weeks prior to the first administration of study drug.
- •3\. Participants with other malignant tumor within the past 5 years, other than the tumor treated in this study, with the exception of locally cured tumors .
- •4\. Participants with related AEs (except for alopecia and ≤ Grade 2 sensory neuropathy) caused by previous treatment that have not recovered to ≤ Grade 1 or baseline level.
- •5\. Participants with known weight loss of \>10% within 2 months before the first dose of the study drug or other indicators showing severe malnutrition.
- •6\. Participants with serious complications or medical histories involving important organs.
Arms & Interventions
HDM2024
Experimental
HDM2024 ( the antibody-drug conjugate (ADC) drug targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3) )
Intervention: HDM2024 (Drug)
Outcomes
Primary Outcomes
Maximal tolerance dose (MTD) of HDM2024
Time Frame: DLT will be evaluated on 21 days of observation period
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.
Determination of the Recommended Phase 2 dose (RP2D)
Time Frame: Approximately 1 years
Incidence and severity of Treatment-Emergent Adverse Events
Time Frame: Approximately 1 years
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.
Secondary Outcomes
- Half-life time (t1/2) of HDM2024(Approximately 1year)
- Peak Plasma Concentration (Cmax) of HDM2024(Approximately 1 year)
- Area under the plasma concentration versus time curve (AUC) of HDM2024(approximately 1 year)
- Objective response rate (ORR)(Approximately 1 year)
- Disease control rate (DCR)(Approximately 1 year)
- Progression-free survival (PFS)(Approximately 1year)
- Overall survival (OS)(Approximately 1 year)
- Time to peak (Tmax) of HDM2024(Approximately 1 years)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
A Phase 1 Study of HDM2017 in Advanced Solid TumorsNCT07274085Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.96
Not yet recruiting
Not Applicable
A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological MalignanciesNCT07294300Qilu Pharmaceutical Co., Ltd.124
Not yet recruiting
Phase 1
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult ParticipantsUC - Ulcerative ColitisNCT07505030LyncBio Therapeutics Co., Ltd.50
Not yet recruiting
Not Applicable
Study of TYK-01054 Capsules in Patients With Advanced Solid TumorsNCT07282873TYK Medicines, Inc219
Not yet recruiting
Phase 1
Study of QLS5308 in Patients With Advanced Solid TumorsNCT07462442Qilu Pharmaceutical Co., Ltd.192