A Study of DM005 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDoma Biopharmaceutical（Suzhou）Co., Ltd.
About this trial
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit.
Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Common inclusion criteria for both Parts
Participants must have the ability to understand and willingness to sign a written informed consent document.
Participants who have pathologically or cytologically documented metastatic/advanced NSCLC, gastroesophageal cancer, CRC, HCC, pancreatic cancer, or HNSCC, not curable with standard local therapies (i.e., surgery and/or radiation) and have progressed on standard therapy, or intolerant to standard therapy.
Participants must be ≥18 years of age on the day of signing the informed consent form (ICF).
Disqualifiers
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 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 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.
Trial design
Design model
Sequential
Treatments tested in this trial
DM005
DrugAn IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W.
Treatment groups
208 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Group E: Dose Level 5Experimental treatment 1 intervention
Group F: Dose Level 6Experimental treatment 1 intervention
Group G: Dose Level 7Experimental treatment 1 intervention
Group H: Dose Level 8Experimental treatment 1 intervention
Group I: Dose Level 9Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicities (DLTs) of DM005
Incidence of DLTs of DM005 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity.
Time frame
12 months2
Maximum tolerated dose (MTD) for DM005
The MTD of DM005 will be determined. The MTD was 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.
Time frame
12 monthsSecondary outcomes
1
The MTD of DM005 will be determined. The MTD was 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 plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation.
Time frame
12 months2
Maximum (peak) plasma concentration (Cmax, ng/mL)
Maximum concentration, obtained directly from the observed concentration versus time data.
Time frame
12 months3
Time to maximum (peak) concentration (Tmax, h)
Time to Cmax
Time frame
12 months4
Trough concentration (Ctrough, ng/mL)
The lowest plasma concentration reached before the next dose.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov