NCT07274085 A Phase 1 Study of HDM2017 in Advanced Solid Tumors
| NCT ID | NCT07274085 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a phase I clinical study. All subjects are patients with advanced solid tumors. The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary antitumor efficacy of HDM2017 in patients with advanced malignant solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Be able and willing to provide written informed consent. 2. Male or female participants aged 18 to 75 years. 3. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors who have failed adequate standard of care, or are intolerant to standard of care, or have no effective standard treatment options. 4. Be able to provide archived tumor tissue during the screening period. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Life expectancy ≥3 months. 7. According to RECIST v1.1, participants must have at least one measurable lesion. 8. Has adequate organ function. 9. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 7 months after the last dose of study treatment. 10. Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures