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A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors

PHASE1PHASE2RECRUITING

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat.

This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them.

This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV).

Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries.

This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV, with or without tucatinib, is for participants with solid tumors. This study will also test what side effects happen when participants take these drugs.

A side effect is anything a drug does to the body besides treating the disease.

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Study details:

This clinical trial is to evaluate disitamab vedotin alone and in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-low LA/mBC subjects.

Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk ratio has been determined the disitamab vedotin plus tucatinib combination therapy will be evaluated in an expansion phase with 2 expansion cohorts in subjects with HER2 low mGC/GEJC and HER2 + LA/mBC.

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Eligibility criteria

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

Inclusion criteria

  • Measurable disease according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2 status IHC 1+ or higher by most recent local assessment.
  • Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
  • Histologically or cytologically confirmed diagnosis of breast carcinoma
  • HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
  • No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
  • Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
  • Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy
  • Participants with HR+ tumors must have endocrine therapy refractory disease: Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
  • Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy.
  • Participants must have: Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy.
  • Participants must have: Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
  • Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
  • Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks
  • Participants must have received: Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
  • Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
  • Prior anti-PD-(L)1 therapy is allowed
  • No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
  • Must not have received prior treatment with HER2 directed therapy
  • Exclusion criteria

  • Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
  • Prior therapy with ADCs with MMAE payload
  • Prior therapy with tucatinib
  • Active CNS and/or leptomeningeal metastasis.
  • Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
  • History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  • Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-05-20

    Primary completion: 2030-01-31

    Study completion finish: 2030-01-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT06157892

    Intervention or treatment

    DRUG: disitamab vedotin

    DRUG: tucatinib

    Conditions

    • Gastroesophageal Junction Adenocarcinoma
    • Metastatic Breast Cancer
    • Breast Neoplasms
    • HER2 Low Breast Neoplasms
    • HER2 Positive Breast Neoplasms
    • Stomach Neoplasms
    • Triple Negative Breast Neoplasms
    • Metastatic Gastric Cancer
    • Advanced Breast Cancer
    • Advanced Gastric Cancer
    Image related to Gastroesophageal Junction Adenocarcinoma
    • Condition: Gastroesophageal Junction Adenocarcinoma, Metastatic Breast Cancer and more

    • DRUG: disitamab vedotin and other drugs

    • Frankston, Other, Australia

    • Sponsor: Seagen Inc.

    Find a site

    Closest Location:

    Peninsula and South East Oncology

    Research sites nearby

    Select from list below to view details:

    • Peninsula and South East Oncology

      Frankston, Other, Australia

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    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 Escalation - Previously treated advanced GC/GEJC or breast cancer
    • disitamab vedotin + tucatinib
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)
    EXPERIMENTAL: Cohort A monotherapy - HER2-low 2L or 3L breast cancer
    • disitamab vedotin monotherapy
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)
    EXPERIMENTAL: Cohort A - HER2-low 2L or 3L breast cancer
    • disitamab vedotin + tucatinib
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)
    EXPERIMENTAL: Cohort B monotherapy - HER2+ 3L or higher breast cancer
    • disitamab vedotin monotherapy
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)
    EXPERIMENTAL: Cohort B - HER2+ 3L or higher breast cancer
    • disitamab vedotin + tucatinib
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)
    EXPERIMENTAL: Cohort C monotherapy - HER2-low 2L GC/GEJC
    • disitamab vedotin monotherapy
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)
    EXPERIMENTAL: Cohort C - HER2-low 2L GC/GEJC
    • disitamab vedotin + tucatinib
    DRUG: disitamab vedotin
    • Given into the vein (IV; intravenous)

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Number of participants with dose limiting toxicities DLTs) in dose escalation phaseNot SpecifiedUp to 28 days
    Number of participants with adverse events (AEs)Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventionThrough 30 days after the last study treatment; approximately 5 years
    Number of participants with laboratory abnormalitiesNot SpecifiedThrough 30-37 days after the last study treatment: approximately 5 years
    Number of participants with dose alterationsNot SpecifiedThrough 30-37 days after the last study treatment: approximately 5 years
    Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessmentThe proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.Approximately 3 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Duration of response (DOR) per RECIST v1.1 by investigator assessmentThe time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any causeApproximately 5 years
    Disease control rate (DCR) per RECIST v1.1 by investigator assessmentThe proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1.Approximately 5 years
    Progression free survival (PFS) per RECIST v1.1 by investigator assessmentThe time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.Approximately 5 years
    Overall survival (OS)The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the date of death due to any cause.Approximately 5 years
    Pharmacokinetic (PK) parameter - Maximum concentration (Cmax)Not SpecifiedThrough 30-37 days after the last study treatment; approximately 5 years
    PK parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)Not SpecifiedApproximately 1 month
    Incidence of anti-drug antibodies (ADAs) against disitamab vedotinNot SpecifiedThrough 30-37 days after the last study treatment; approximately 5 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors

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