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

A Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: HDM2017; Drug: Fruquintinib

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ruichao Zeng; Phone Number: 0571-89918267; Email: zengruichao@eastchinapharm.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital
      • Contact: Lin Shen; Phone Number: 010-88196561; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HDM2017 in combination with fruquintinib	Drug: HDM2017; Following a predefined dose and date.; Drug: Fruquintinib; Following a predefined dose and date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Maximum Tolerated Dose (MTD)	The MTD will be determined using DLTs	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed blood concentration	30 days after the last dose of IMP
Incidence of anti-drug antibody (ADA)	The proportion of patients with positive ADA results	30 days after the last dose of IMP
Duration of Response (DoR)	The time from first documented evidence of CR or PR until time of first documented disease progression.	30 days after the last dose of IMP
Tmax	Time to reach the maximum blood concentration	30 days after the last dose of IMP]
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)	30 days after the last dose of IMP
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	30 days after the last dose of IMP
Overall survival (OS)	OS is defined as the time from first dose until death due to any cause	30 days after the last dose of IMP

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: HMPL-013
• Other Study ID Numbers: HDM2017-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No