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Not yet recruitingLast updated: 8 April 2024

SGNDV-004: This study is testing how safe and effective a new drug (called disitamab vedotin) is when given alone, or in addition to targeted therapy, in people with breast or stomach solid cancersA Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors

Clinical summary

Summary

Participants in this study must have breast or gastric (stomach) cancer, and their tumours must express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV), which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This study also uses a targeted therapy called tucatinib.

The study has a dose escalation phase evaluating DV plus tucatinib, followed by a dose optimisation phase.

The two dose levels identified in the dose escalation phase will be assessed in the optimisation phase for both safety and efficacy in HER2-low locally advanced or metastatic breast cancer participants.

Once the safety and efficacy profile od DV plus tucatinib has been established, and a DV dose with the optimum benefit/risk ratio has been determined the DV plus tucatinib combination therapy will be evaluated in an expansion phase with two cohorts of participants with HER2-low metastatic gastric cancer or gastro-oesophageal junction cancer, and HER2+ locally advanced or metastatic breast cancer. 

DV will be given intravenously (via IV), and tucatinib will given administered twice daily by mouth (orally). 

Conditions

This trial is treating patients with locally advanced or metastatic stomach or breast cancers that are HER2 positive

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

SGNDV-004

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Seagen Inc.

Scientific Title

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors

Eligibility

Inclusion

General Inclusion Criteria

  • Measurable disease according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Dose Escalation Phase Inclusion Criteria

  • 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.

Cohort A (HER2-Low Breast Cancer) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of breast carcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
  • Prior therapies requirements

    • 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.

Cohort B (HER2+ Breast Cancer) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis breast carcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
  • Participants must have:

    • Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy.
    • Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
    • No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC

Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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