Status:
ACTIVE_NOT_RECRUITING
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Lead Sponsor:
Seagen, a wholly owned subsidiary of Pfizer
Conditions:
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06003231
Start Date
November 14 2023
End Date
May 31 2028
Last Update
December 31 2025
Active Locations (94)
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1
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
2
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Gilbert, Arizona, United States, 85297
3
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Glendale, Arizona, United States, 85306
4
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States, 85202