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Not yet recruitingNCT07621159Updated Jun 2, 2026

A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer

A Phase 1/2 interventional study of HDM2017 and Fruquintinib in Colorectal Cancer Metastatic, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase Ib/II clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.

02

Conditions studied

  • Colorectal Cancer Metastatic
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be able and willing to provide written informed consent.
  2. Male or female participants with age ≥ 18 years.
  3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.
  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.

Exclusion criteria

Exclusion Criteria:

  1. Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).
  2. Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
  3. Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).
  4. Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.
  5. Known weight loss of >10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.
  6. History of severe esophagogastric varicose vein, severe ulcer, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.
  7. Participants with current imaging or clinical evidence of significant gastrointestinal obstruction.
  8. Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose.
  9. Participants with known active CNS metastasis.
  10. Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations.
  11. Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    HDM2017 in combination with fruquintinib

    Drug: HDM2017 · Drug: Fruquintinib

Interventions

  • DrugHDM2017

    Following a predefined dose and date.

  • DrugFruquintinib

    Following a predefined dose and date.

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: 30 days after the last dose of IMP

Secondary outcomes

  1. Tmax

    Time to reach the maximum blood concentration

    Time frame: 30 days after the last dose of IMP]

  2. Cmax

    Maximum observed blood concentration

    Time frame: 30 days after the last dose of IMP

  3. Incidence of anti-drug antibody (ADA)

    The proportion of patients with positive ADA results

    Time frame: 30 days after the last dose of IMP

  4. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1)

    Time frame: 30 days after the last dose of IMP

  5. Duration of Response (DoR)

    The time from first documented evidence of CR or PR until time of first documented disease progression.

    Time frame: 30 days after the last dose of IMP

  6. Progression Free Survival (PFS)

    PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause

    Time frame: 30 days after the last dose of IMP

  7. Overall survival (OS)

    OS is defined as the time from first dose until death due to any cause

    Time frame: 30 days after the last dose of IMP

06

Study locations

1 site
  • Peking University Cancer Hospital
    Beijing, Beijing Municipality 100142, China
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
NCT07621159
Lead sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 2, 2026
Start date
Jul 15, 2026 (estimated)
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Jun 2, 2026

Study contacts

Ruichao Zeng
Contact
zengruichao@eastchinapharm.com
0571-89918267

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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