NCT07805551 A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer
| NCT ID | NCT07805551 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | CRC, Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2026-08-18 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2026-08-18 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. The study is divided into two periods: dose escalation (Phase Ib) and dose expansion (Phase II). Phase Ib of this study is a dose-finding study of different HDM2017 combination therapies. The Phase II study will be conducted at a dose determined to be safe and potentially effective in Phase Ib.
Eligibility Criteria
Inclusion Criteria: 1. Participants must voluntarily participate in this study and sign the written ICF after being fully informed. 2. Male or female participants aged 18 to 75 years (inclusive). 3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic CRC. 4. Able to provide fresh or archived tumor tissue samples during the screening period. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 6. Life expectancy ≥ 3 months. 7. Participants must have at least one measurable lesion according to RECIST v1.1. 8. Laboratory test results at the screening period must indicate that the participant has adequate organ function. 9. Women of childbearing potential (WOCBP) must agree to use a reasonable method of contraception from the time of signing the ICF until 7 months after the last dose; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose. Male participants must agree to use adequate contraception from the first dose until 7 months after the last dose. 10. Participants must be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Prior or current treatment with topoisomerase I (TOP I) inhibitor drugs. 2. Prior or current treatment targeting CDH17. 3. Presence of other malignant tumor, other than the tumor being treated in this study. 4. AEs from prior therapy that have not resolved to Grade 1 or baseline status before prior therapy. 5. Active central nervous system (CNS) metastasis; metastases to meninges or brainstem metastasis; presence of spinal cord compression. 6. Presence of diseases that may affect the efficacy and safety of the IMP. 7. Known or suspected allergic reaction or contraindication to any component of the IMP or its analogues. 8. Pregnant or lactating women, or those who plan to become pregnant during the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07805551 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying CRC, Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07805551 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07805551 currently recruiting?
Yes, NCT07805551 is actively recruiting participants. Contact the research team at doctorshenlin@sina.cn for enrollment information.
Where is the NCT07805551 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07805551 clinical trial?
NCT07805551 is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. The trial plans to enroll 220 participants.
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