Testing DM001 in patients with advanced solid tumors

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

This study is testing a new treatment called DM001 to see if it can help people with advanced solid tumors while keeping track of any side effects.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Doma Biopharmaceutical（Suzhou）Co., Ltd. (industry)
• Drugs / interventions: prednisone
• Locations: 5 sites (Nashville, Tennessee and 4 other locations)
• Trial ID: NCT06475937 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and preliminary efficacy of DM001, an experimental bispecific antibody-drug conjugate, in patients with advanced solid tumors. The study is designed as a Phase 1, multicenter, open-label trial that includes a dose-escalation and dose-expansion approach. Participants will undergo a series of visits over a treatment period divided into 3-week cycles, with assessments of their response to the drug and any side effects experienced. The trial aims to gather important pharmacokinetic data and insights into the drug's effectiveness against various types of advanced cancers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced breast cancer, non-small cell lung cancer, or other specified solid tumors who have progressed on or are intolerant to standard therapies.

Not a fit: Patients with active invasive malignancies other than the specified solid tumors or those with hematologic malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies involving bispecific antibody-drug conjugates have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
2. Subjects who have pathologically or cytologically confirmed documented metastatic/advanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer, gastroesophageal cancer or CRC, and have progressed on standard therapy, or intolerant to standard therapy, or no standard therapy accessible to the subjects due to any reason.
3. Subjects must be ≥18 years of age at the time of signing the informed consent form.
4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Has a life expectancy of ≥3 months.
6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

1. Subjects have another active invasive malignancy within 5 years.
2. Current or history of a hematologic malignancy.
3. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\>20 mg prednisone or equivalent) for at least 4 weeks.
4. Individuals with Gilbert's disease with ≥3 × ULN.
5. Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals.
6. Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period.
7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
8. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF, QTcF=QT/\[RR\]1/3) \>470 msec obtained from triplicate 12-lead ECGs at baseline; no concomitant medications that would prolong the QT internal; no family history of long QT syndrome.
9. Known human immunodeficiency virus infection, or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Chronic carriers of HBV infection (hepatitis B surface antigen-positive, undetectable, or low HBV DNA) who receive prophylactic treatment during the study can be enrolled. Subjects 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 RNA negative due to prior treatment or natural resolution should be eligible.
10. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
11. Subjects who are of reproductive potential refuse to use effective methods of birth control during the course of participation in the study and within 120 days for both women and men of the last dose are ineligible to participate in the study.

Where this trial is running

Nashville, Tennessee and 4 other locations

• Sarah Cannon Research Institute (SCRI) — Nashville, Tennessee, United States (RECRUITING)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Icon Cancer Centre South Brisbane — South Brisbane, Queensland, Australia (RECRUITING)
• Tasman Oncology Research — Southport, Queensland, Australia (RECRUITING)
• Monash Health — Clayton, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Xi Cheng

Conditions: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Solid Carcinoma