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RecruitingNCT07805551Updated Sep 4, 2026

A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer

A Phase 1/2 interventional study of HDM2017 and Bevacizumab in CRC, Colorectal Cancer, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
220
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • CRC, Colorectal Cancer

Keywords

  • HDM2017
  • CRC
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil

    Drug: HDM2017 · Drug: Bevacizumab · Drug: Oxaliplatin · Drug: Fluorouracil · Drug: Leucovorin

  • Experimental
    HDM2017 + bevacizumab + leucovorin + fluorouracil

    Drug: HDM2017 · Drug: Bevacizumab · Drug: Fluorouracil · Drug: Leucovorin

  • Experimental
    HDM2017 + bevacizumab + oxaliplatin + capecitabine

    Drug: HDM2017 · Drug: Bevacizumab · Drug: Oxaliplatin · Drug: Capecitabine

Interventions

  • DrugHDM2017

    Administered with continuing until protocol-specified criteria for treatment discontinuation are met

  • DrugBevacizumab

    administered with continuing until protocol-specified criteria for treatment discontinuation are met

  • DrugOxaliplatin

    administered with continuing until protocol-specified criteria for treatment discontinuation are met

  • DrugFluorouracil

    administered with continuing until protocol-specified criteria for treatment discontinuation are met

  • DrugCapecitabine

    administered with continuing until protocol-specified criteria for treatment discontinuation are met

  • DrugLeucovorin

    administered with dosing continuing until protocol-specified criteria for treatment discontinuation are met

05

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    The MTD will be determined using DLTs

    Time frame: 30 days after the last dose of IMP

  2. Recommended Phase 2 Dose (RP2D)

    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

    Time frame: 30 days after the last dose of IMP

  3. Type, incidence and severity of Adverse Events

    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v6.0

    Time frame: 30 days after the last dose of IMP

  4. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).

    Time frame: From date of first-dosing until the date of first documented progression or date of 30 days after the last dose of IMP, whichever came first, assessed up to about 12 months

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: 30 days after the last dose of IMP

  2. Duration of Response (DoR)

    Time frame: From date of confirm ORR until the date of first documented progression, assessed up to about 36 months

  3. Progression Free Survival (PFS)

    Time frame: From date of first-dosing/randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to about 36 months

  4. Overall survival (OS)

    Time frame: From date of first-dosing/randomization until the end of the trail or date of death from any cause, whichever came first, assessed up to about 48 months

  5. Incidence of anti-drug antibody (ADA)

    Time frame: 30 days after the last dose of IMP

06

Study locations

1 of 1 sites recruiting
  • Peking University Cancer Hospital
    Beijing, Beijing Municipality 100142, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07805551
Lead sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Aug 18, 2026
Primary completion
Aug 2030 (estimated)
Completion
Aug 2032 (estimated)
Last update
Sep 4, 2026

Study contacts

Lin Shen
Contact
doctorshenlin@sina.cn
010-88196561

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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