The goal of study：
The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.
The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.
In Part 2, participants will receive the best dose level that was determined in Part 1 of the study.
The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.
Participants will:
Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
Subjects must have the ability to understand and willingness to sign a written informed consent document.
Subjects must be ≥18 years of age at the time of signing the informed consent form.
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Has a life expectancy of ≥3 months.
History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.
Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).
Current or history of a hematologic malignancy.
Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.
Sequential
DM002
DrugAn IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W
Dose-limiting Toxicities (DLTs) of DM002
Incidence of DLTs of DM002 will be determined. A dose-limiting toxicity (DLT) is defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicities.
Maximum tolerated dose (MTD) for DM002
The MTD of DM002 will be determined. The MTD is defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose.
Area Under the Curve（AUC，ng·h/mL）
Area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation.
Maximum (peak) plasma concentration (Cmax, ng/mL)
Maximum concentration, obtained directly from the observed concentration versus time data.
Time to maximum (peak) concentration (Tmax, h)
Time to Cmax
Trough concentration (Ctrough, ng/mL)
The lowest plasma concentration reached before the next dose.
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