A Study of HDM2005 in Patients With Advanced Solid Tumor

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: HDM2005

Study type: Interventional

Funder types: Industry

Identifiers

NCT07004296

HDM2005-103

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 1 patient group

HDM2005

Experimental group

Description:

In dose escalation phase, participants will be administered escalating doses of HDM2005 at 1.8\~2.5mg/kg IV on Day 1 of repeated 21-day cycles or 1.2\~2.0mg/kg IV on Day 1 of repeated 14-day cycles . In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 .

Treatment:

Drug: HDM2005