Carcinoma, Non-Small-Cell LungPhase 1/2NCT06515990
A Study of DM005 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing DM005 in people with Carcinoma, Non-Small-Cell Lung and Squamous Cell Carcinoma of Head and Neck, run by Doma Biopharmaceutical（Suzhou）Co., Ltd. at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Solid Carcinoma
- What is being tested?
- DM005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 Oct 2024to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2.
- Has a life expectancy ≥3 months.
- Has measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Participants have another active invasive malignancy within 5 years, with the following exceptions and notes:
- 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.
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- 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.
- 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.
- Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
- Has clinically significant corneal disease.
- 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.
- 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.
- 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.
- 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.
- 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).
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- 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.
- Females who are pregnant or lactating or who intend to become pregnant during participation in the study.
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75251
Reva Schneider
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Shirish Gadgeel
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
ALEXANDER SPIRA
Australia3 sites, 3 recruiting
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales
Adrian Pokorny
- Recruiting
Macquarie University Hospital
North Ryde, New South Wales
Andrew Parsonson
- Recruiting
ICON Cancer Center
South Brisbane, Queensland, 4101
Jermaine Coward
About this study
Official title: A Phase I/IIa, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors
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.
Read the detailed description
This first-in-human (FIH), multicenter, open-label, dose escalation and dose expansion study is to evaluate the safety, preliminary efficacy and pharmacokinetic (PK) characteristics of DM005 monotherapy in participants with advanced solid tumors.
DM005, a bispecific ADC developed using fully human antibodies with a common light chain, which targets c-MET and EGFR.
Subjects with solid malignant tumors will be treated with DM005 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose
- Being tested
- DM005
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM005Drug
An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 0.5mg/kg Receives: Drug: DM005 |
| Dose Level 2 | Experimental | ≤1 mg/kg Receives: Drug: DM005 |
| Dose Level 3 | Experimental | ≤1.6 mg/kg Receives: Drug: DM005 |
| Dose Level 4 | Experimental | ≤2.5 mg/kg Receives: Drug: DM005 |
| Dose Level 5 | Experimental | ≤3.3 mg/kg Receives: Drug: DM005 |
| Dose Level 6 | Experimental | ≤4.2 mg/kg Receives: Drug: DM005 |
| Dose Level 7 | Experimental | ≤5.2 mg/kg Receives: Drug: DM005 |
| Dose Level 8 | Experimental | ≤6.5 mg/kg Receives: Drug: DM005 |
| Dose Level 9 | Experimental | ≤8 mg/kg Receives: Drug: DM005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
Maximum (peak) plasma concentration (Cmax, ng/mL)
Maximum concentration, obtained directly from the observed concentration versus time data.
Measured: 12 months
Time to maximum (peak) concentration (Tmax, h)
Time to Cmax
Measured: 12 months
Trough concentration (Ctrough, ng/mL)
The lowest plasma concentration reached before the next dose.
Measured: 12 months
Objective response rate (ORR)
ORR is defined as the number of patients with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment using RECIST version 1.1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start31 Oct 2024
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doma Biopharmaceutical（Suzhou）Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515990
- Sponsor's protocol ID
- DM005001
- Status last verified
- Jan 2026
- First submitted
- 17 Jul 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06515990
- Acronym / sponsor ID
- DM005001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Doma Biopharmaceutical（Suzhou）Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This first-in-human (FIH), multicenter, open-label, dose escalation and dose expansion study is to evaluate the safety, preliminary efficacy and pharmacokinetic (PK) characteristics of DM005 monotherapy in participants with advanced solid tumors.
DM005, a bispecific ADC developed using fully human antibodies with a common light chain, which targets c-MET and EGFR.
Subjects with solid malignant tumors will be treated with DM005 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: DM0050.5mg/kg |
| Dose Level 2 | Experimental | Drug: DM005≤1 mg/kg |
| Dose Level 3 | Experimental | Drug: DM005≤1.6 mg/kg |
| Dose Level 4 | Experimental | Drug: DM005≤2.5 mg/kg |
| Dose Level 5 | Experimental | Drug: DM005≤3.3 mg/kg |
| Dose Level 6 | Experimental | Drug: DM005≤4.2 mg/kg |
| Dose Level 7 | Experimental | Drug: DM005≤5.2 mg/kg |
| Dose Level 8 | Experimental | Drug: DM005≤6.5 mg/kg |
| Dose Level 9 | Experimental | Drug: DM005≤8 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Common inclusion criteria for both Parts
Key exclusion criteria (19 listed)
- Participants are excluded from the study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM005An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W. | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8, Dose Level 9 |
Primary outcome
Dose-limiting Toxicities (DLTs) of DM005
Time frame: 12 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 DM005
Time frame: 12 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.
5 secondary outcomes
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 months
Maximum (peak) plasma concentration (Cmax, ng/mL)
Time frame: 12 months
Time to maximum (peak) concentration (Tmax, h)
Time frame: 12 months
Trough concentration (Ctrough, ng/mL)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DM005 in people with Carcinoma, Non-Small-Cell Lung and Squamous Cell Carcinoma of Head and Neck, run by Doma Biopharmaceutical（Suzhou）Co., Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjun Yu (+86 18952761813, wenjun.yu@domabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities (DLTs) of DM005 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.