NCT07805551RecruitingPhase 1/2
A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HDM2017 Combination Therapy in Participants With Advanced Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 18 Aug 2026
- Primary completion date
- Aug 2030
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT07805551
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 220
- From 18 Aug 2026 to the primary completion date, Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current treatment with topoisomerase I (TOP I) inhibitor drugs.
- Prior or current treatment targeting CDH17.
- AEs from prior therapy that have not resolved to Grade 1 or baseline status before prior therapy.
Other illness
- Presence of other malignant tumor, other than the tumor being treated in this study.
- Presence of diseases that may affect the efficacy and safety of the IMP.
- Known or suspected allergic reaction or contraindication to any component of the IMP or its analogues.
Other
- Active central nervous system (CNS) metastasis; metastases to meninges or brainstem metastasis; presence of spinal cord compression.
- Pregnant or lactating women, or those who plan to become pregnant during the study.
Who the study is looking for
- Participants must voluntarily participate in this study and sign the written ICF after being fully informed.
- Male or female participants aged 18 to 75 years (inclusive).
- Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic CRC.
- Able to provide fresh or archived tumor tissue samples during the screening period.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Life expectancy ≥ 3 months.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Laboratory test results at the screening period must indicate that the participant has adequate organ function.
- 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.
- Participants must be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.