A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

Phase 2

Active, not recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Endometrial Neoplasms; Head and Neck Neoplasms
• Interventions: Drug: disitamab vedotin

• Registration Number: NCT06003231
• Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Brief Summary

This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2.

This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks.

This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-21
• Study Start: 2023-11-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-27
• Primary Completion: 2026-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Cohort 1: Head and neck cancer (HNC)

  • Must have pathologically-documented carcinoma of the head and neck with primary tumor site arising from the oral cavity, salivary gland, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded.

  • Unresectable locally recurrent or metastatic stage disease

  • Prior therapies:

    • Participants must have disease progression after treatment with a platinum-based therapy

• Cohort 2: Non-small cell lung cancer (NSCLC)

  • Pathologically documented NSCLC

  • Unresectable locally-advanced or metastatic stage disease

  • Prior therapies

    • Must have progressed during or after a platinum-based therapy for LA/metastatic disease or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease
    • Must have received prior anti-PD(L)1 therapy, unless contraindicated
    • Participants with known AGAs must have received appropriate targeted therapy, where available.
    • No more than 2 prior lines of cytotoxic chemotherapy for advanced disease

• Cohort 3: Ovarian Cancer

  • Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin

  • Unresectable locally-advanced or metastatic stage disease

  • Prior therapies

    • Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence)
    • Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease
    • Participants with known BRCA mutations are permitted, but participants must have received targeted therapy with a PARP inhibitor
    • May have received prior anti-PD(L)1 therapy

• Cohort 4: Endometrial Cancer

  • Must have pathologically documented adenocarcinoma of the endometrium

  • Must have unresectable locally-advanced or metastatic stage disease.

  • Prior therapies

    • Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease
    • Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease
    • May have received prior anti-PD(L)1 therapy

• HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue. Note: Participants with HER2 mutations are eligible.

• Measurable disease per RECIST v1.1 criteria as assessed by the investigator

• Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides)

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria

• Prior treatment with an MMAE-containing agent.
• Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
• History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
• Active untreated CNS or leptomeningeal metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Head and neck cancer	disitamab vedotin	Disitamab vedotin monotherapy
Non-small cell lung cancer	disitamab vedotin	Disitamab vedotin monotherapy
Ovarian cancer	disitamab vedotin	Disitamab vedotin monotherapy
Endometrial cancer	disitamab vedotin	Disitamab vedotin monotherapy

Primary Outcome Measures

Name	Time	Method
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment	Approximately 3 years	The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator

Secondary Outcome Measures

Name	Time	Method
Number of participants with laboratories abnormalities	Through 30-37 days after the last dose of DV; approximately 5 years
Overall Survival (OS)	Approximately 5 years	The time from the start of study treatment to the date of death due to any cause
Number of participants with adverse events (AEs)	Through 30-37 days after the last dose of DV; approximately 5 years	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
PK parameter - Maximum concentration (Cmax)	Through 30-37 days after the last dose of DV; approximately 5 years	Analyzed through end of treatment.
Incidence of antidrug antibodies (ADAs)	Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with dose alterations due to AEs	Approximately 5 years
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment	Approximately 5 years	The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
PK parameter - Trough concentration (Ctrough)	Through 30-37 days after the last dose of DV; approximately 5 years	Analyzed through end of treatment.
Duration of Response (DOR) per RECIST v1.1 by investigator assessment	Approximately 5 years	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
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)	Approximately 1 month	Analyzed through cycle 2.
Progression free survival (PFS) per RECIST v1.1 by investigator assessment	Approximately 5 years	PFS is defined as the time from the start of study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first

Trial Locations

Locations (82)

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers; 🇺🇸 Scottsdale, Arizona, United States

Valkyrie Clinical Trials(Additional Suite); 🇺🇸 Los Angeles, California, United States

Valkyrie Clinical Trials; 🇺🇸 Los Angeles, California, United States

University of California Davis Comprehenvise Cancer Center; 🇺🇸 Sacramento, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Providence Medical Foundation; 🇺🇸 Santa Rosa, California, United States

Colorado West Healthcare System, dba Community Hospital; 🇺🇸 Grand Junction, Colorado, United States

Colorado West Healthcare, dba Grand Valley Oncology; 🇺🇸 Grand Junction, Colorado, United States

Smilow Cancer Hospital at Yale - New Haven; 🇺🇸 New Haven, Connecticut, United States

Yale-New Haven Hospital-Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

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