A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2

Cancer Categories

Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin

Karmanos Trial ID

2023-069

NCT ID

NCT06003231

Age Group

Adult

Scope

National

Phase

Phase II

Principal Investigator

Ammar
Sukari, M.D.
Oncology - Medical View Profile

Objective:

Primary Objective:

To evaluate the antitumor activity of disitamab vedotin in subjects with previously treated, locally-advanced unresectable or metastatic (LA/m) HER2 expressing solid tumors

Secondary Objectives:

To evaluate the safety and tolerability profile of disitamab vedotin
To assess other measures of antitumor activity of disitamab vedotin per investigator assessment by other clinically relevant measures
To evaluate the pharmacokinetics (PK) of disitamab vedotin
To evaluate the immunogenicity of disitamab vedotin

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Eligibility

Inclusion Criteria:

Cohort 1: Head and neck squamous cell carcinoma (HNSCC)

Pathologically-documented squamous cell carcinoma of the head and neck with primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and larynx
Unresectable locally recurrent or metastatic stage disease
Prior therapies:

Participants must have disease progression after treatment with a platinum-based therapy
No more than 1 line of cytotoxic chemotherapy for advanced disease

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 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
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
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

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices