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

NCT07621159 | Not Yet Recruiting Phase 1

• 1 other identifier: HDM2017-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (4)

• Maximum Tolerated Dose (MTD)

  The MTD will be determined using DLTs

  30 days after the last dose of IMP]

• Recommended Phase 2 Dose (RP2D)

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

  30 days after the last dose of IMP

• Type, incidence and severity of Adverse Events

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

  30 days after the last dose of IMP

• 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).

  30 days after the last dose of IMP

Secondary Outcomes (7)

• Tmax

  30 days after the last dose of IMP]

• Cmax

  30 days after the last dose of IMP

• Incidence of anti-drug antibody (ADA)

  30 days after the last dose of IMP

• Disease control rate (DCR)

  30 days after the last dose of IMP

• Duration of Response (DoR)

  30 days after the last dose of IMP

Study Arms (1)

HDM2017 in combination with fruquintinib

EXPERIMENTAL

Drug: HDM2017; Drug: Fruquintinib

Interventions

HDM2017 DRUG

Following a predefined dose and date.

HDM2017 in combination with fruquintinib

Fruquintinib DRUG

Following a predefined dose and date.

HDM2017 in combination with fruquintinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able and willing to provide written informed consent.
• Male or female participants with age ≥ 18 years.
• Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.
• Be able to provide archived tumor tissue during the screening period.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Life expectancy ≥3 months.
• According to RECIST v1.1, participants must have at least one measurable lesion.
• Has adequate organ function.
• 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.
• Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.

You may not qualify if:

• Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).
• Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
• 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).
• Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.
• Known weight loss of \>10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.
• 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.
• Participants with current imaging or clinical evidence of significant gastrointestinal obstruction.
• Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose.
• Participants with known active CNS metastasis.
• Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations.
• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

HMPL-013

Central Study Contacts

Ruichao Zeng

CONTACT

0571-89918267; zengruichao@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)