A Study of HDM2024 in Participants With Advanced Solid Tumors

NCT07539285 | Recruiting Phase 1

• 1 other identifier: HDM2024-101
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

ADC; advanced solid tumors; EGFR; HER3

Outcome Measures

Primary Outcomes (3)

• 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.

  DLT will be evaluated on 21 days of observation period

• Determination of the Recommended Phase 2 dose (RP2D)

  Approximately 1 years

• 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.

  Approximately 1 years

Secondary Outcomes (8)

• Time to peak (Tmax) of HDM2024

  Approximately 1 years

• 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

Study Arms (1)

HDM2024

EXPERIMENTAL

HDM2024 ( the antibody-drug conjugate (ADC) drug targeting epidermal growth factor receptor (EGFR) \& human epidermal growth factor receptor 3 (HER3) )

Drug: HDM2024

Interventions

HDM2024 DRUG

ADC drug targeting EGFR and HER3

HDM2024

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participants who voluntarily participate in this study and sign the written Informed Consent Form (ICF) after being fully informed.
• \. Male or female participants aged 18 to 75 years (inclusive).
• \. 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.
• \. 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 .
• \. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 .
• \. Life expectancy ≥3 months.
• \. According to RECIST v1.1, the participant must have at least one measurable lesion .
• \. Participants with good organ function as demonstrated by screening laboratory test results.
• \. 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.
• \. Participants should be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• \. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and/or HER3.
• \. 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.
• \. 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 .
• \. 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.
• \. Participants with known weight loss of \>10% within 2 months before the first dose of the study drug or other indicators showing severe malnutrition.
• \. Participants with serious complications or medical histories involving important organs.
• \. Participants with known active central nervous system (CNS) metastasis.
• \. Participants with any of the cardiovascular/cerebrovascular disorders, symptoms, or manifestations.
• \. Participants with the following conditions will be excluded at screening: active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), with the exception of asymptomatic chronic hepatitis B or C virus carriers.
• \. Participants with a history of interstitial pneumonia or other moderate to severe lung disorders that seriously affect lung function.
• \. Participants with severe infection during the screening period.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Central Study Contacts

Zhou Caicun

CONTACT

+8613301825532; caicunzhoudr@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 20, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): December 28, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)