A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

STATUS

Recruiting
End date

Jul 31, 2023
participants needed

264
sponsor

Seagen Inc.

Send

Updated on 10 May 2022

See if I qualify

cancer

systemic therapy

measurable disease

growth factor

melanoma skin

BRAF

metastasis

progressive disease

chemoradiotherapy

epidermal growth factor receptor

HER2

EGFR

chemotherapy regimen

extensive disease

human epidermal growth factor

solid tumors

cancer chemotherapy

adenocarcinoma

targeted therapy

erbb2

squamous cell carcinoma of head and neck

platinum-based chemotherapy

immunomodulators

immunologic adjuvant

malignant melanoma of skin

Summary

This trial will study ladiratuzumab vedotin (LV) to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.

Description

This trial is designed to assess the antitumor activity, safety, and tolerability of LV for the treatment of solid tumors. Participants with the following advanced solid tumors will be

enrolled

Cohort 1: small cell lung cancer (SCLC) Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous) Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous) Cohort 4: head and neck squamous cell carcinoma (HNSCC) Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma

Participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death, whichever comes first.

Details

Condition	Small Cell Lung Cancer, Non-small Cell Lung Cancer, Squamous, Non-small Cell Lung Cancer, Non-squamous, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Prostate Cancer, Melanoma
Treatment	ladiratuzumab vedotin
Clinical Study Identifier	NCT04032704
Sponsor	Seagen Inc.
Last Modified on	10 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	All Cohorts
	Measurable disease according to RECIST v1.1 as assessed by the investigator
	Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
	Cohort 1: SCLC
	Must have extensive stage disease
	Must have disease progression during or following prior platinum-based systemic chemotherapy for extensive stage disease
	No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
	No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
	May have received prior anti-PD(L)1 therapy
	Cohort 2: NSCLC-squamous
	Must have unresectable locally advanced or metastatic disease
	Must have disease progression during or following systemic therapy
	Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
	Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease
	Participants with known epidermal growth factor receptor (EGFR), anaplastic
	lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other
	No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
	Must have received prior anti-PD(L)1 therapy, unless contraindicated
	actionable mutations are not eligible
	Cohort 3: NSCLC-nonsquamous
	Must have unresectable locally advanced or metastatic disease
	Must have disease progression during or following systemic therapy
	Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
	Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease
	Must have had prior platinum-based chemotherapy
	No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
	Participants with known EGFR, ALK, ROS, BRAF, tropomyosin receptor kinase (TRK)
	Must have received prior anti-PD(L)1 therapy, unless contraindicated
	or other actionable mutations are not eligible
	Cohort 4: HNSCC
	Must have unresectable locally recurrent or metastatic disease
	Must have disease progression during or following prior line of systemic therapy
	Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; or
	Recurrence/progression within 6 months of last dose of platinum therapy given as part of a multimodal therapy in the curative setting
	No more than 1 line of cytotoxic chemotherapy for their advanced disease
	May have received prior anti-PD(L)1 therapy, unless contraindicated
	Cohort 5: esophageal-squamous
	Must have unresectable locally advanced or metastatic disease
	Must have disease progression during or following systemic therapy
	Must have had prior platinum-based chemotherapy
	No more than 1 line of cytotoxic chemotherapy for their advanced disease
	Cohort 6: gastric and GEJ adenocarcinoma
	Must have unresectable locally advanced or metastatic disease
	Must have received prior platinum-based therapy
	Must have disease progression during or following systemic therapy
	Participants with known human epidermal growth factor receptor 2 (HER2) overexpression must have received prior HER2-targeted therapy
	No more than 1 line of prior cytotoxic chemotherapy for their advanced disease
	Participants may have received prior anti-PD(L)1 therapy, unless contraindicated
	Cohort 7: CRPC
	Must have histologically or cytologically confirmed adenocarcinoma of the prostate
	Participants with components of small cell of neuroendocrine histology are excluded
	Must have metastatic castration-resistant disease
	Must have received no more than 1 prior line of androgen receptor-targeted therapy for metastatic castration-sensitive prostate cancer or CRPC
	No prior cytotoxic chemotherapy in the metastatic CRPC setting
	For participants who received cytotoxic chemotherapy in CSPC, at least 6 months must have elapsed between last dose of chemotherapy and start of study treatment
	Must have been ≥28 days between cessation of androgen receptor-targeted therapy and start of study treatment
	No more than 1 prior line of cytotoxic chemotherapy for CSPC
	Participants with measurable soft tissue disease must have evidence of measurable soft tissue disease according to PCWG3 criteria
	Participants with measurable and non-measurable disease are eligible if the
	Participants with non-measurable disease must have documented rising PSA levels or appearance of new lesion according to PCWG3
	following criteria are met
	Participants with known breast cancer gene (BRCA) mutations are excluded
	A minimum starting PSA level ≥1.0 ng/mL
	Cohort 8: Melanoma
	Must have histologically or cytotoxically confirmed cutaneous malignant melanoma
	Participants with mucosal, acral, or uveal melanoma are excluded
	Must have locally advanced unresectable or metastatic stage disease
	No prior radioscope therapy or radiotherapy to ≥30% of bone marrow
	Must have measurable disease
	Must have progressive disease following anti-PD(L)1 therapy
Exclusion Criteria
	Active concurrent malignancy or a previous malignancy within the past 3 years
	Any anticancer therapy within 3 weeks of starting study treatment. Participants who are/were on adjuvant hormonal therapy for the treatment of malignancies with negligible risk of metastases are eligible
	Known active central nervous system lesions
	Active viral, bacterial, or fungal infection requiring systemic treatment within 7 days prior to the first dose of LV
	Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
	Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure
	Has received prior radiotherapy within 2 weeks of start of study treatment
	Has received a live vaccine within 30 days of the planned start of study therapy
	Ongoing sensory or motor neuropathy of Grade ≥2

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Study Definition

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A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors