Phase 1 HDM2017 for 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 trial will test an experimental drug called HDM2017 in adults with advanced solid tumors to see if it is safe and has any anti-tumor activity.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07274085 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study gives HDM2017 to adults with locally advanced unresectable or metastatic solid tumors who have exhausted standard treatment options. The main aims are to characterize safety, tolerability, and pharmacokinetics, while also looking for preliminary anti-tumor effects. Eligible participants must have measurable disease per RECIST v1.1, ECOG performance status 0–1, adequate organ function, and provide archived tumor tissue and contraception if of reproductive potential. The study is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical and is conducted at Peking University Cancer Hospital in Beijing.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed unresectable or metastatic solid tumors who have failed or are intolerant to standard therapies, have at least one measurable lesion, ECOG 0–1, and adequate organ function are the intended participants.

Not a fit: Patients with early-stage resectable disease, ECOG performance status above 1, significant organ dysfunction, or those unable to provide required tissue samples or attend study visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HDM2017 could offer a new treatment option for patients with advanced solid tumors who have limited or no effective standard therapies left.

How similar studies have performed: As an early-phase first-in-human program, HDM2017 is largely untested in large clinical trials, though other investigational agents for advanced solid tumors have occasionally shown responses in Phase 1 settings.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ruichao Zeng

Conditions: Solid Tumors