OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

A Study of DM005 in Patients With Advanced Solid Tumors

PHASE1PHASE2RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Participants must have the ability to understand and willingness to sign a written informed consent document.
  2. 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.
  3. Participants must be ≥18 years of age on the day of signing the informed consent form (ICF).
  4. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2.
  5. Has a life expectancy ≥3 months.
  6. Has measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1.

Exclusion criteria

  1. 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).
  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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT06515990

Intervention or treatment

DRUG: DM005

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Squamous Cell Carcinoma of Head and Neck
  • Solid Carcinoma

  • Condition: Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck and more

  • DRUG: DM005

  • South Brisbane, Queensland, Australia

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

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

ICON Cancer Center

Select from list below to view details:

  • ICON Cancer Center

    South Brisbane, Queensland, Australia

Loading map...

Who is running the clinical trial?

DBL

Doma Biopharmaceutical（Suzhou）Co., Ltd.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dose Level 1
  • 0.5mg/kg
Drug: DM005
    EXPERIMENTAL: Dose Level 2
    • ≤1 mg/kg
    Drug: DM005
      EXPERIMENTAL: Dose Level 3
      • ≤1.6 mg/kg
      Drug: DM005
        EXPERIMENTAL: Dose Level 4
        • ≤2.5 mg/kg
        Drug: DM005
          EXPERIMENTAL: Dose Level 5
          • ≤3.3 mg/kg
          Drug: DM005
            EXPERIMENTAL: Dose Level 6
            • ≤4.2 mg/kg
            Drug: DM005
              EXPERIMENTAL: Dose Level 7
              • ≤5.2 mg/kg
              Drug: DM005
                EXPERIMENTAL: Dose Level 8
                • ≤6.5 mg/kg
                Drug: DM005
                  EXPERIMENTAL: Dose Level 9
                  • ≤8 mg/kg
                  Drug: DM005

                    What is the study measuring?

                    Primary Outcome

                    MeasureDescriptionTime Frame
                    Dose-limiting Toxicities (DLTs) of DM005Incidence 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.12 months
                    Maximum tolerated dose (MTD) for DM005The 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.12 months

                    Secondary Outcome

                    MeasureDescriptionTime Frame
                    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.12 months
                    Maximum (peak) plasma concentration (Cmax, ng/mL)Maximum concentration, obtained directly from the observed concentration versus time data.12 months
                    Time to maximum (peak) concentration (Tmax, h)Time to Cmax12 months
                    Trough concentration (Ctrough, ng/mL)The lowest plasma concentration reached before the next dose.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 1.112 months
                    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                    Claim this trial

                    References

                    Clinical Trials Gov: A Study of DM005 in Patients With Advanced Solid Tumors

                    Other trials to consider

                    Loading suggested trials...

                    Top searched conditions

                    Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular