A Phase 1 Study of HDM2017 in Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Antitumor Efficacy of HDM2017 in Participants With Advanced Malignant Solid Tumors

This is a phase I clinical study. All subjects are patients with advanced solid tumors. The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary antitumor efficacy of HDM2017 in patients with advanced malignant solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: HDM2017

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ruichao Zeng; Phone Number: +86-571-89903388; Email: zengruichao@eastchinapharm.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • 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 aged 18 to 75 years.
3. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors who have failed adequate standard of care, or are intolerant to standard of care, or have no effective standard treatment options.
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 ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.

2. Participants who have received the following treatments:

   1. Participants who have undergone major surgery within 4 weeks before the first dose;
   2. Participants who have received radiotherapy involving the bone marrow or extensive radiotherapy within 4 weeks before the first dose; or local radiotherapy within 2 weeks before the first dose;
   3. Participants receiving continuous systemic corticosteroid therapy;
   4. Participants who have received systemic antitumor therapy, or any other investigational drug therapy within 4 weeks or 5 half-lives (whichever is shorter; at least 2 weeks) before the first dose.
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 gastrointestinal perforation, abdominal fistula, or extensive intestinal resection within 6 months before the first dose; complete or incomplete gastrointestinal obstruction or intra-abdominal abscess within 3 months before the first dose.
7. History of gastrointestinal hemorrhage within 3 months before the first dose, or a clear gastrointestinal hemorrhagic diathesis.
8. Participants with known active CNS metastasis.
9. Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations.
10. 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; Participants will receive escalating doses of HDM2017, then at least 2 dose levels will be selected for dose expansion to determine the RP2D	Drug: HDM2017; Participants will be treated with HDM2017 intravenous infusion

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
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 v5.0	30 days after the last dose of IMP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to reach the maximum blood concentration	30 days after the last dose of IMP
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
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
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
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
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 (Actual): November 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HDM2017-101

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