RecruitingPhase 2

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

United States172 participantsStarted 2024-05-20

Plain-language summary

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 tucatinib works 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: General Inclusion Criteria * Measurable disease according to RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Dose Escalation and Optimization Phase Inclusion Criteria * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma * Locally-advanced, unresectable, or metastatic stage * 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 intolerance to endocrine therapy or 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 s…

What they're measuring

Number of participants with dose limiting toxicities (DLTs) in dose escalation phase

Timeframe: Up to 28 days

Number of participants with adverse events (AEs)

Timeframe: Through 30 days after the last study treatment; approximately 5 years

Number of participants with laboratory abnormalities

Timeframe: Through 30-37 days after the last study treatment: approximately 5 years

Number of participants with dose alterations

Timeframe: 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

Timeframe: Approximately 3 years

Trial details

NCT IDNCT06157892

SponsorSeagen, a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-07-28

Contact for this trial

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

View on ClinicalTrials.gov More Breast Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with dose limiting toxicities (DLTs) in dose escalation phase

Timeframe: Up to 28 days

Number of participants with adverse events (AEs)

Timeframe: Through 30 days after the last study treatment; approximately 5 years

Number of participants with laboratory abnormalities

Timeframe: Through 30-37 days after the last study treatment: approximately 5 years

Number of participants with dose alterations

Timeframe: 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

Timeframe: Approximately 3 years