DM002 for Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Xadcera 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: 20

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DM002 for individuals with advanced solid tumor cancers. The first part of the trial focuses on identifying the safest dose by gradually increasing it among participants. Once researchers determine the optimal dose, the second part will assess how the cancer responds to the treatment. This trial suits those living with advanced solid tumors who are willing to undergo regular check-ups and treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had anticancer therapy within 28 days before the first study dose, and you should avoid drugs or food that strongly affect certain liver enzymes (CYP3A4/5) within 2 weeks before starting the trial.

Is there any evidence suggesting that DM002 is likely to be safe for humans?

Research has shown that DM002, the treatment under study, has been safely used for other medical conditions. Specifically, dimethyl fumarate (DMF), a key component of DM002, has been safely used for about nine years in people with multiple sclerosis. This history suggests that DM002 might be safe for humans.

In early animal studies, DM002 demonstrated strong effects against tumors and was generally safe. These results are promising, but it's important to remember that animal studies don't always predict human responses.

This trial is in its early stages and aims to determine the safe dose levels of DM002 for treating advanced solid tumor cancers. The main focus is to ensure the treatment's safety for humans. By joining this trial, participants will help researchers find the best dose that balances safety and effectiveness. ^{1 2 3 4 5}

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

Unlike other treatments for cancer that typically involve chemotherapy or radiation, DM002 is unique because it targets the disease at a molecular level. This investigational drug is designed to work by interfering with specific proteins that cancer cells need to grow, making it potentially more precise and less damaging to healthy cells. Researchers are excited about DM002 because it offers a new way to attack cancer, possibly leading to fewer side effects and improved outcomes for patients.

What evidence suggests that DM002 might be an effective treatment for cancer?

Research has shown that DM002, a new cancer treatment, holds promise in fighting various types of cancer. Early lab studies demonstrated its effectiveness against lung, breast, stomach, and pancreatic cancers. DM002 targets specific proteins, HER3 and MUC1, often present in large amounts on cancer cells. This targeting helps deliver the treatment directly to the cancer cells, potentially shrinking the tumors. Although these results come from early studies, they offer hope that DM002 could be effective against solid tumors in people. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors who can consent to treatment, have a life expectancy of at least 3 months, and are in relatively good physical condition (ECOG status of 0-2). They must have adequate blood cell counts and kidney function. People cannot join if they've had certain treatments within two weeks before the study starts.

Inclusion Criteria

I meet the general requirements for both parts of the study.

I can understand and am willing to sign the consent form.

My hemoglobin level is 9 g/dL or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment - Part 1: Dose Escalation

Participants receive escalating doses of DM002 to evaluate safety and determine the maximum tolerated dose

Varies by cohort, with cycles of 3 weeks each

17 or more visits (in-person)

Treatment - Part 2: Dose Expansion

Participants receive the best dose level determined in Part 1 to evaluate safety and cancer response

Cycles of 3 weeks each

End of Treatment (EOT)

Participants have an EOT visit 21 days after the final study drug treatment

3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person), followed by telephone contact every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• DM002

Trial Overview DM002 is being tested in patients with various advanced solid tumors. The trial has two parts: Part 1 finds the safest dose by starting low and increasing it for new participants; Part 2 uses this best dose to further assess safety, how the body processes DM002, and its effect on cancer.

How Is the Trial Designed?

Group I: Dose Level 6 Experimental Treatment 1 Intervention

≤7.5 mg/kg

Group II: Dose Level 5 Experimental Treatment 1 Intervention

≤6.0 mg/kg

Group III: Dose Level 4 Experimental Treatment 1 Intervention

≤4.5 mg/kg

Group IV: Dose Level 3 Experimental Treatment 1 Intervention

≤3.0 mg/kg,

Group V: Dose Level 2 Experimental Treatment 1 Intervention

≤2.0 mg/kg

Group VI: Dose Level 1 Experimental Treatment 1 Intervention

1.0 mg/kg

Who Is Running the Clinical Trial?

Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

Lead Sponsor

Trials

2

Recruited

290+

Published Research Related to This Trial

In a phase I study involving 12 patients with newly diagnosed glioblastoma, dimethyl fumarate (DMF) was safely combined with standard treatments of radiotherapy and temozolomide, with no dose-limiting toxicities observed.

The recommended phase 2 dose (RP2D) for DMF was established at 240 mg three times daily, and the median progression-free survival was 8.7 months, with a median overall survival of 13.8 months, indicating potential efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of dimethyl fumarate, temozolomide, and radiation therapy in glioblastoma. Shafer, D., Tombes, MB., Shrader, E., et al.[2022]

In a study involving 125 young adults with relapsing-remitting multiple sclerosis, those continuously treated with dimethyl fumarate (DMF) showed a significantly lower annualized relapse rate (ARR) of 0.24 compared to 0.56 in those who received placebo, indicating DMF's efficacy in reducing disease activity.

The safety profile of DMF in young adults was favorable, with most adverse events being mild to moderate, and a high percentage (81%) of patients on DMF showed no confirmed disability progression after approximately 7 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Amezcua, L., Mao-Draayer, Y., Vargas, WS., et al.[2023]

In a first-in-human phase I study involving 51 patients with advanced solid tumors, CGM097 was found to be tolerable with no dose-limiting toxicities, although delayed-onset thrombocytopenia was a common side effect.

The disease control rate was 39%, with one patient achieving a partial response and 19 patients maintaining stable disease, indicating limited but notable antitumor activity and providing insights for optimizing dosing regimens for future HDM2 inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic-pharmacodynamic guided optimisation of dose and schedule of CGM097, an HDM2 inhibitor, in preclinical and clinical studies. Bauer, S., Demetri, GD., Halilovic, E., et al.[2023]

T-DM1 effectively induces cell death in HER2-positive breast cancer cell lines by blocking the cell cycle at the G2/M phase, demonstrating its potential as a therapeutic agent.

However, T-DM1 does not enhance the effectiveness of radiation therapy, as it does not increase radiosensitivity in these cancer cells, indicating that further in vivo studies are necessary to fully understand its interactions with radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro effects of Trastuzumab Emtansine (T-DM1) and concurrent irradiation on HER2-positive breast cancer cells. Mignot, F., Kirova, Y., Verrelle, P., et al.[2021]

Citations

1. domabio.com domabio.com/upload/file/20240411/6e811d05ef632f11ea2741301d741b84.pdf

Preclinical efficacy of DM002, a bispecific HER3×MUC1-C ... The potential indications of DM002 under research are focusing on lung cancer, breast cancer, CRC, pancreatic cancer, ovarian cancer and gastric ...

2. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A1284

1165 Preclinical evaluation of fully human bispecific ... DM002 demonstrated robust in vivo efficacy in cell line-derived and patient-derived xenografts (PDX) with varying levels of HER3 and MUC1 ...

3. withpower.com withpower.com/trial/phase-1-colorectal-neoplasms-2025-4e74f

DM002 for Cancer · Recruiting Participants for Phase ... What data supports the effectiveness of the drug DM002 for cancer? The drug T-DM1, which may be similar to DM002, has been shown to extend survival in patients ...

4. researchgate.net researchgate.net/publication/370037316_Abstract_LB214_A_first-in-class_bispecific_antibody-drug_conjugate_DM002_targeting_HER3_and_the_juxtamembrane_domain_of_MUC1

Abstract LB214: A first-in-class bispecific antibody-drug ... DM002 candidates showed robust anti-tumor activity in multiple CDX and PDX models of lung, breast, gastric and pancreatic cancer; most notably, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12480482/

Antibody–drug conjugates in breast cancer: mechanisms of ... Antibody drug conjugates (ADCs) have revolutionized tumor treatment, but resistance often limits long-term efficacy. Available data on the full ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2025-03834

A Study of DM002 in Patients With Advanced Solid Tumors 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, ...

7. aacrjournals.org aacrjournals.org/cancerres/article/83/8_Supplement/LB214/725225/Abstract-LB214-A-first-in-class-bispecific

A first-in-class bispecific antibody-drug conjugate (DM002 ... DM002 candidates showed robust anti-tumor activity in multiple CDX and PDX models of lung, breast, gastric and pancreatic cancer; most notably, ...

8. en.domabio.com en.domabio.com/n-31/23.html

Doma's bispecific ADC, DM002, has received US FDA IND ... In preclinical studies, DM002 demonstrated robust antitumor activity and a favorable safety profile. Notably, in animal models, DM002 ...

9. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/2621/737299/Abstract-2621-Preclinical-Efficacy-of-DM002-a

Preclinical Efficacy of DM002, a bispecific HER3 × MUC1 ... MUC1 is a known tumor-associated antigen (TAA), but previous anti-MUC1 agents have shown limited clinical efficacy due to neutralization by ...