Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGHDM2017
Participants will be treated with HDM2017 intravenous infusion
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 30 days after the last dose of IMP | The MTD will be determined using DLTs |
| Recommended Phase 2 Dose (RP2D) | 30 days after the last dose of IMP | The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data |
| Type, incidence and severity of Adverse Events | 30 days after the last dose of IMP | Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 30 days after the last dose of IMP | ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1). |
| Disease control rate (DCR) | 30 days after the last dose of IMP | DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1). |
| Tmax | 30 days after the last dose of IMP | Time to reach the maximum blood concentration |
| Progression Free Survival (PFS) | 30 days after the last dose of IMP | PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. |
| Overall survival (OS) | 30 days after the last dose of IMP | OS is defined as the time from first dose until death due to any cause. |
| Duration of Response (DoR) | 30 days after the last dose of IMP | The time from first documented evidence of CR or PR until time of first documented disease progression. |
| Cmax | 30 days after the last dose of IMP | Maximum observed blood concentration |
| Incidence of anti-drug antibody (ADA) | 30 days after the last dose of IMP | The proportion of patients with positive ADA results |
Countries
China
Contacts
Primary ContactRuichao Zeng
Outcome results
None listed