Study of DM005 for Advanced Solid Tumors
This study is testing an experimental drug called DM005 in people with advanced solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and other solid cancers. DM005 is given through an IV (intravenous) infusion every three weeks. Researchers want to understand how safe DM005 is, what dose is best tolerated, and if it can help treat these cancers. DM005 works by targeting specific proteins called c-MET and EGFR on cancer cells. You may be eligible if you have one of these advanced cancers that cannot be cured with standard treatments. The study is currently recruiting participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know you are receiving DM005. It aims to enroll 136 participants and will look at increasing doses of the drug.
- What's involved
- You would have a screening period of up to 28 days, followed by treatment cycles where DM005 is given every three weeks. After treatment, there will be an end of treatment visit and a follow-up visit about 30 days later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have a follow-up visit about 30 days after their last treatment visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06515990
A Study of DM005 in Patients With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentDoma Biopharmaceutical（Suzhou）Co., Ltd.
~208 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:DM005
At a glance
Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting Toxicities (DLTs) of DM005
Measured over 12 months
+1 more outcome measured
Conditions
Where it's being run
6 sites across 5 statesNew South Wales2
Michigan1
Texas1
Virginia1
Queensland1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Participants are excluded from the study if any of the following criteria apply:
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). 2. Current or history of hematologic malignancy. 3. 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. 4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (\>20 mg prednisone or equivalent) for at least 4 weeks. 5. Presence of bulky disease (defined as any single mass \>7 cm in its greatest dimension). Individuals with a mass \>7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor. 6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals. 7. Has clinically significant corneal disease. 8. Has a corrected QT interval (QTcF) prolongation to \>470 ms (for both genders) based on average of the Screening triplicate 12-lead ECG determinations; no concomitant medications that would prolong the QT interval; no known family history of long QT syndrome. 9. Left ventricular ejection fraction (LVEF) \<50% by either an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan within 28 days before first dose of the study drug. 10. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies/ml or 500 IU/ml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible. 11. Known human immunodeficiency virus (HIV) infection which is not well controlled. participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)/ethics committee. All the following criteria are required to define an HIV infection (positive HIV1/2 antibodies test) that is well controlled: HIV viral load \<400 copies/mL, CD4+ T-cell counts ≥350 cells/μL, no history of acquired immunodeficiency syndrome \[AIDS\])-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications. 12. Participants from endemic area will be specifically screened for tuberculosis. Participants with active tuberculosis are excluded. Participants who have received bacille Calmette-Guerin (BCG) vaccination may have a false positive result in the purified protein derivative (PPD) skin test. These participants are eligible if they have a negative Interferon Gamma Release Assay (IGRA). 13. Has received a live vaccine within 30 days prior to the first dose of study drug. 14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to NCI-CTCAE version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \>Grade 2 for at least 3 months prior to enrollment/randomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia. 15. Females who are pregnant or lactating or who intend to become pregnant during participation in the study. 16. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.
What this trial measures
- Dose-limiting Toxicities (DLTs) of DM00512 months
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.
- Maximum tolerated dose (MTD) for DM00512 months
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.