Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07004296

A Study of HDM2005 in Patients With Advanced Solid Tumor

Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-06-08

72

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.

CONDITIONS

Official Title

A Study of HDM2005 in Patients With Advanced Solid Tumor

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Agree to follow the study protocol and voluntarily sign consent
  • Male or female aged 18 years or older
  • ECOG performance status of 0-1
  • Life expectancy of at least 3 months
  • Confirmed advanced solid tumors by tissue examination
  • Metastatic disease progressed after prior appropriate treatment
  • Provide archived or fresh tissue for ROR1 expression testing
  • Radiographically measurable disease present
  • Recovered to Grade 1 or less from any prior anticancer therapy side effects
  • Adequate organ function
  • Female participants of childbearing potential must use contraception and have a negative pregnancy test; males must agree to contraception during and 6 months after the study
Not Eligible

You will not qualify if you...

  • Active brain metastases (unstable, symptomatic, or requiring certain medications)
  • Another primary cancer except treated non-melanoma skin cancer or carcinoma in situ without recurrence
  • History of severe bleeding disorders
  • History of pancreatitis within 6 months
  • History or evidence of active interstitial lung disease or radiation pneumonitis
  • Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
  • Prior solid organ transplant
  • Peripheral neuropathy greater than Grade 1
  • Significant cardiovascular or cerebrovascular disease
  • Uncontrolled infection
  • Active infectious diseases like HIV, active hepatitis B or C, or active syphilis
  • Receiving corticosteroids above a certain dose
  • Contraindication to any HDM2005 components
  • History of severe allergic reactions or uncontrolled asthma or COPD
  • Pregnant, lactating, or planning pregnancy during study
  • Mental illness or substance abuse impacting study cooperation
  • Any medical condition or treatment that might affect study outcomes or safety as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

J

Jun Zhou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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