HDM2005 for advanced solid tumors

A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HDM2005 in Patients With Advanced Solid Tumors

This trial will test whether HDM2005 is safe and has anti-tumor activity in adults with metastatic solid tumors that have progressed after prior treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07004296 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed metastatic solid tumors that progressed after prior appropriate treatments, ECOG 0-1, measurable disease, adequate organ function, and willingness to provide tumor tissue for ROR1 testing are the intended participants.

Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under three months, inadequate organ function, or who cannot provide required tumor tissue are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HDM2005 could offer a new treatment option that slows tumor growth for patients whose metastatic solid tumors no longer respond to standard therapies.

How similar studies have performed: Other early-phase programs targeting ROR1 and related tumor antigens have shown acceptable safety and occasional responses, but this specific agent is novel and unproven.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Fudan University shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jun Zhou

Conditions: Advanced Solid Tumors