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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

TREATMENT

Phase

PHASE1

PHASE2

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.

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. Claim or learn more.

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

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants with dose limiting toxicities DLTs) in dose escalation phase	Not Specified	Up 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 intervention	Through 30 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities	Not Specified	Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations	Not Specified	Through 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 assessment	The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.	Approximately 3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Duration of response (DOR) per RECIST v1.1 by investigator assessment	The 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 cause	Approximately 5 years
Disease control rate (DCR) per RECIST v1.1 by investigator assessment	The 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 assessment	The 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 Specified	Through 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 Specified	Approximately 1 month
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin	Not Specified	Through 30-37 days after the last study treatment; approximately 5 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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 Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors