HDM2017 combination therapy in advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase Ib/II trial evaluating HDM2017 in combination with bevacizumab, oxaliplatin, fluorouracil, and capecitabine for advanced colorectal cancer. It uses a dose-escalation phase to identify a safe and potentially effective regimen, followed by a dose-expansion phase at that level to further assess activity. The study looks at safety, how the drug is processed in the body, and preliminary anti-tumor signals. Participants must have measurable disease, adequate organ function, and be suitable for systemic therapy with acceptable performance status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Lin Shen
• Email: doctorshenlin@sina.cn
• Phone: 010-88196561

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.