Recruiting NCT07274085
A Phase 1 Study of HDM2017 in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HDM2017.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug HDM2017
Participants will be treated with HDM2017 intravenous infusion
Primary outcome measures
- Maximum Tolerated Dose (MTD) [Time frame: 30 days after the last dose of IMP]
- Recommended Phase 2 Dose (RP2D) [Time frame: 30 days after the last dose of IMP]
- Type, incidence and severity of Adverse Events [Time frame: 30 days after the last dose of IMP]
Secondary outcome measures (8)
- Tmax [Time frame: 30 days after the last dose of IMP]
- Cmax [Time frame: 30 days after the last dose of IMP]
- Incidence of anti-drug antibody (ADA) [Time frame: 30 days after the last dose of IMP]
- Objective Response Rate (ORR) [Time frame: 30 days after the last dose of IMP]
- Disease control rate (DCR) [Time frame: 30 days after the last dose of IMP]
- Duration of Response (DoR) [Time frame: 30 days after the last dose of IMP]
- Progression Free Survival (PFS) [Time frame: 30 days after the last dose of IMP]
- Overall survival (OS) [Time frame: 30 days after the last dose of IMP]
Eligibility criteria
Inclusion criteria
- Be able and willing to provide written informed consent.
- Male or female participants aged 18 to 75 years.
- 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.
- 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.
Exclusion criteria
- Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
- Participants who have received the following treatments:
- Participants who have undergone major surgery within 4 weeks before the first dose;
- 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;
- Participants receiving continuous systemic corticosteroid therapy;
- 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.
- 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 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.
- History of gastrointestinal hemorrhage within 3 months before the first dose, or a clear gastrointestinal hemorrhagic diathesis.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Cancer Hospital — Beijing
Identifiers
NCT: NCT07274085 · HDM2017-101