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Carcinoma, Non-Small-Cell LungPhase 2NCT06003231

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

A Phase 2 study testing disitamab vedotin in people with Carcinoma, Non-Small-Cell Lung and Ovarian Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 96 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
disitamab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
96 sitesin 7 countries
Study dates
14 Nov 2023to 31 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 32Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

96 sites in 7 countries.

96 sites in 7 countries

United States75 sites

  • Optimum Clinical Research Group, LLC

    Albuquerque, New Mexico, 87109

  • Southwest Women's Oncology Inc

    Albuquerque, New Mexico, 87109

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Wellstar MCG Health Clinical Research Pharmacy

    Augusta, Georgia, 30912

  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota, 55337

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Allina Health Cancer institute

    Coon Rapids, Minnesota, 55433

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota, 55433

  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

  • University of Miami Hospital and Clinics Deerfield Beach

    Deerfield Beach, Florida, 33442

  • PCM Trails

    Denver, Colorado, 80218

  • PCM Trials

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center, Investigational Chemotherapy Services

    Durham, North Carolina, 27710

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • M Health Fairview Cancer Clinic-Edina

    Edina, Minnesota, 55435

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Minnesota Oncology Hematology, P.A.

    Fridley, Minnesota, 55432

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Gilbert, Arizona, 85297

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Glendale, Arizona, 85306

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Valkyrie Clinical Trials(Additional Suite)

    Los Angeles, California, 90067

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota, 55369

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, 85202

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, 85206

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida, 33176

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • NYU Langone Hospital-Long Island

    Mineola, New York, 11501

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Allina Health Cancer Institute (Virginia Piper Cancer Institute)

    Minneapolis, Minnesota, 55404

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Smilow Cancer Hospital at Yale - New Haven

    New Haven, Connecticut, 06510

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Laura & Isaac Perlmutter Cancer Center At NYU Langone

    New York, New York, 10016

  • Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)

    New York, New York, 10016

  • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

    New York, New York, 10016

  • NYU Langone Hospitals

    New York, New York, 10016

  • NYU Langone Medical Center (Tisch Hospital)

    New York, New York, 10016

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Phoenix, Arizona, 85028

  • Sylvester Comprehensive Cancer Center Plantation

    Plantation, Florida, 33324

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Oncology and Hematology Care Clinic - Westside

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center- Investigational Drug Services

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • North Memorial Health Cancer Center

    Robbinsdale, Minnesota, 55422

  • University of California Davis Comprehenvise Cancer Center

    Sacramento, California, 95817

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Regulatory location : MMCORC

    Saint Louis Park, Minnesota, 55426

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Allina Health Cancer Institute-United(VPCI)

    Saint Paul, Minnesota, 55102

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Scottsdale, Arizona, 85260

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Swedish First Hill IDS Pharmacy

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Smilow Cancer Hospital Care Center at Trumbull

    Trumbull, Connecticut, 06611

  • Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center

    Woodbury, Minnesota, 55125

Other trials in United States

Australia8 sites

  • Blacktown Hospital

    Blacktown, 2148

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peninsula & South Eastern Hematology and Oncology Group (PASO)

    Frankston, Victoria, 3199

  • Macquarie University Clinical Trials Unit.

    Macquarie University, New South Wales, 2109

  • Macquarie University Clinic

    Macquarie University, New South Wales, 2109

  • Macquarie University Hospital Pharmacy

    Macquarie University, New South Wales, 2109

  • Macquarie University Hospital

    Macquarie University, New South Wales, 2109

  • Baxter Healthcare

    Old Toongabie, New South Wales, 2146

Other trials in Australia

Spain4 sites

  • Hospital General Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Provincial

    Córdoba, 14004

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

South Korea3 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

United Kingdom3 sites

  • The Royal Marsden NHS Foundation Trust (RM)

    London, SW3 6JJ

  • The Royal Marsden NHS Foundation Trust (RM)

    Sutton, Surrey, SM2 5PT

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Canada2 sites

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1

  • Centre Intégré de Cancérologie du CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4

Other trials in Canada

Italy1 site

  • Fondazione IRCCS San Gerardo dei Tintori.

    Monza (MB), Monza and Brianza, 20900

Other trials in Italy

About this study

Official title: A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

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.

Being tested
disitamab vedotin
Keywords
NSCLC, Ovarian Cancer, Endometrial Cancer, Head and Neck Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • disitamab vedotinDrug

    Also called RC48, RC48-ADC

    Given into the vein (IV, intravenous) every 2 weeks

Study groups in NCT06003231
Study groupRoleWhat they receive
Head and neck cancerExperimentalDisitamab vedotin monotherapy
Receives: Drug: disitamab vedotin
Non-small cell lung cancerExperimentalDisitamab vedotin monotherapy
Receives: Drug: disitamab vedotin
Ovarian cancerExperimentalDisitamab vedotin monotherapy
Receives: Drug: disitamab vedotin
Endometrial cancerExperimentalDisitamab vedotin monotherapy
Receives: Drug: disitamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

    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

    Measured: Approximately 3 years

Secondary outcomes (11)

  1. 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

    Measured: Through 30-37 days after the last dose of DV; approximately 5 years

  2. Number of participants with laboratories abnormalities

    Measured: Through 30-37 days after the last dose of DV; approximately 5 years

  3. Number of participants with dose alterations due to AEs

    Measured: Approximately 5 years

  4. Confirmed 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

    Measured: Approximately 5 years

  5. 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

    Measured: Approximately 5 years

  6. Progression free survival (PFS) per RECIST v1.1 by investigator assessment

    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

    Measured: Approximately 5 years

  7. Overall Survival (OS)

    The time from the start of study treatment to the date of death due to any cause

    Measured: Approximately 5 years

  8. Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)

    Analyzed through cycle 2.

    Measured: Approximately 1 month

  9. PK parameter - Maximum concentration (Cmax)

    Analyzed through end of treatment.

    Measured: Through 30-37 days after the last dose of DV; approximately 5 years

  10. PK parameter - Trough concentration (Ctrough)

    Analyzed through end of treatment.

    Measured: Through 30-37 days after the last dose of DV; approximately 5 years

  11. Incidence of antidrug antibodies (ADAs)

    Measured: Through 30-37 days after the last dose of DV; approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start14 Nov 2023
  3. Primary completion27 Mar 2026
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06003231
Sponsor's protocol ID
SGNDV-005
Other IDs
C5731005, 2023-504445-31-00, 2023
Status last verified
Jul 2026
First submitted
15 Aug 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing disitamab vedotin in people with Carcinoma, Non-Small-Cell Lung and Ovarian Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 96 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Australia, Spain, South Korea, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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