DM005 for Cancer

Recruiting at 5 trial locations

Overseen By Wenjun Yu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Doma Biopharmaceutical（Suzhou）Co., Ltd.

Must not be taking: Anticancer therapies, High-dose steroids

Disqualifiers: Hematologic malignancy, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 21-day cycles

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DM005 to determine its safety and effectiveness for people with advanced solid tumors, such as certain types of lung, stomach, liver, or pancreatic cancers. DM005 is administered through an IV every three weeks, with different doses tested to find the optimal one. It targets individuals who have not had success with standard cancer treatments. Participants must have a good level of daily functioning and a life expectancy of at least three months to qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that DM005 is likely to be safe for humans?

Research has shown that DM005 has been safe and well-tolerated in earlier studies. In preclinical animal tests, DM005 demonstrated a strong ability to fight tumors without causing serious side effects.

In more recent studies, DM005 continued to be safe, with few severe reactions reported. This is promising for its use in humans, although direct data from human trials remains limited as it is still in the early testing stages. Researchers will closely monitor participants in this trial to gather more safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

DM005 is unique because it offers a novel approach to cancer treatment by targeting specific cancer cell pathways that current treatments may not address. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, DM005 is designed to be more selective, potentially reducing side effects and improving patient outcomes. Researchers are particularly excited about its potential to be more effective at lower doses, which could mean fewer adverse effects for patients compared to standard options like chemotherapy and radiation. This targeted action and the promise of a safer treatment profile make DM005 a promising new candidate in the fight against cancer.

What evidence suggests that DM005 might be an effective treatment for advanced solid tumors?

Research shows that DM005, a new drug tested in this trial, looks promising for treating advanced solid tumors. Studies have found DM005 effective in reducing or stopping tumor growth. It targets two proteins, EGFR and MET, which aid cancer cell survival and growth. By focusing on both proteins, DM005 might overcome the resistance some tumors have to current treatments. Early lab studies suggest that DM005 is likely safe and may be well-tolerated by patients. These initial results offer hope for its potential to treat certain types of cancer. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors like NSCLC, gastroesophageal cancer, and others who have progressed after standard therapy or can't tolerate it. They should be able to perform daily activities (ECOG PS 0-2), have a life expectancy of at least 3 months, measurable disease by RECIST v1.1 criteria, and must understand and agree to the study's consent.

Inclusion Criteria

Participants must have measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1

Participants must have the ability to understand and willingness to sign a written informed consent document

Participants must have a life expectancy ≥3 months

Exclusion Criteria

I have a serious eye condition affecting my cornea.

I haven't had another serious cancer in the last 5 years.

I have a brain tumor or cancer that has spread to my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive DM005 intravenously every 3 weeks, with dose adjustments based on safety and pharmacokinetic data

21-day cycles

1 visit per cycle (in-person)

End of Treatment

End of Treatment visit occurs 7 days after the last treatment cycle

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness 30 days after the End of Treatment visit

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• DM005

Trial Overview

DM005 is being tested in this trial. It's an experimental drug given intravenously every three weeks to treat advanced solid tumors. The first dose lasts about an hour; if well-tolerated, subsequent doses may take half that time under supervision.

How Is the Trial Designed?

Group I: Dose Level 6 Experimental Treatment 1 Intervention

≤8 mg/kg

Group II: Dose Level 5 Experimental Treatment 1 Intervention

≤6 mg/kg

Group III: Dose Level 4 Experimental Treatment 1 Intervention

≤4 mg/kg

Group IV: Dose Level 3 Experimental Treatment 1 Intervention

≤2 mg/kg

Group V: Dose Level 2 Experimental Treatment 1 Intervention

≤1 mg/kg

Group VI: Dose Level 1 Experimental Treatment 1 Intervention

0.5mg/kg

Who Is Running the Clinical Trial?

Doma Biopharmaceutical（Suzhou）Co., Ltd.

Lead Sponsor

Trials

1

Recruited

140+

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15010

DM005: An anti-EGFR/c-MET bispecific antibody-drug ...

Building on extensive preclinical studies, DM005 has demonstrated strong anti-tumor activity, a favorable safety profile, and well-tolerated ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06515990

A 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.

3.

jitc.bmj.com

jitc.bmj.com/content/11/Suppl_1/A1266

1150 DM005, an EGFR × MET bispecific antibody-drug ...

These results suggest that DM005 can be an effective treatment option for EGFR and MET co-expressing tumors and overcome MET-driven EGFR-TKI resistance.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12562412/

Bispecific Antibody and Antibody-Drug Conjugate as Novel ...

Aims to direct T cells to MSLN^+ cancer cells; first patient dosed in 2025. Initial trial results expected 2026; preclinical data suggest high ...

5.

en.domabio.com

en.domabio.com/n-31/20.html

Doma's bispecific ADC(EGFR/c-MET) DM005,has received ...

In the early preclinical studies, DM005 has shown strong anti-tumor activity and good safety. Animal studies indicate that DM005 can achieve ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06515990

A 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.

7.

ascopubs.org

ascopubs.org/doi/pdf/10.1200/JCO.2025.43.16_suppl.e15010

DM005: An anti-EGFR/c-MET bispecific antibody-drug ...

This ongoing multi-center trial is designed to evaluate. DM005's safety, pharmacokinetics, and efficacy in patients with advanced solid tumors, with preliminary ...

8.

researchgate.net

researchgate.net/publication/392305124_DM005_An_anti-EGFRc-MET_bispecific_antibody-drug_conjugate_for_advanced_solid_tumors

DM005: An anti-EGFR/c-MET bispecific antibody-drug ...

Building on extensive preclinical studies, DM005 has demonstrated strong anti-tumor activity, a favorable safety profile, and well-tolerated toxicokinetics in ...