HDM2005 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label interventional trial gives escalating doses of HDM2005 to adults with metastatic solid tumors to determine safety, tolerability, and pharmacokinetics while collecting early signs of anti-tumor activity. Participants must have measurable disease, ECOG 0-1, prior progression on appropriate therapies, adequate organ function, and provide archived or fresh tumor tissue for central ROR1 expression testing. The study monitors adverse events, lab tests, and tumor imaging at scheduled visits and adjusts dosing according to predefined safety criteria. The sponsor is Hangzhou Zhongmei Huadong Pharmaceutical and the study site is Fudan University Shanghai Cancer Center in Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent.
2. Male or female aged ≥ 18 years at the time of signing the ICF;
3. ECOG performance status of 0-1.
4. Life expectancy of at least 3 months.
5. Specific types of advanced solid tumors that have been confirmed by histopathological examination.
6. Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type.
7. All subjects are required to provide archived tissue (5 unstained sections) obtained within the previous 2 years or fresh tissue for ROR1 expression testing at the central laboratory.
8. Presence of radiographically measurable disease.
9. Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy.
10. Has adequate organ function.
11. Female subjects of childbearing potential should agree to use contraception methods during the study and for 6 months after the end of the study; have a negative serum pregnancy test within 7 days before study enrollment; and male subjects should agree to use contraceptive avoidance measures during the study and for 6 months after the end of the study.

Exclusion Criteria:

1. Patients with active brain metastases (defined as stable for \< 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases).
2. Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al.
3. History of severe bleeding disorders .
4. History of chronic pancreatitis or acute pancreatitis within 6 months.
5. History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
6. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage,VEGF inhibitors, platinum and other drugs injection (subjects with stable symptoms for at least one week after treatment can be enrolled).
7. Prior solid organ transplantation.
8. Has peripheral neuropathy of Grade \>1.
9. Has significant cardiovascular or cerebrovascular diseases.
10. Has an uncontrolled ongoing infection.
11. Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis.
12. Receiving corticosteroids (prednisone equivalent more than10 mg/day).
13. Contraindication to any component of HDM2005.
14. History of drug anaphylactic shock, severe food allergy, uncontrolled asthma or COPD.
15. Female subjects who are pregnant, lactating or planning to become pregnant during the study.
16. Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements.
17. Prior or current evidence of any disease, treatment, or laboratory abnormality that, in the opinion of the investigator, could affect the outcome of the study, prevent the subject from participating in the study entirely, or is not in the subjects' best interest.

Where it's running

• Fudan University shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jun Zhou
• Email: hdgdzhoujun@eastchinapharm.com
• Phone: 18061872796

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• AK157D1 injection for advanced solid tumors

  A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

  Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• MK-2010 alone or with other treatments for advanced solid tumors

  This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.

  Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

• Whole-Body Infrared Heating for Advanced Solid Tumors

  This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.

  Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.