TerminatedPhase 2

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Stopped: Study closed due to portfolio prioritization

United States, Australia, Italy205 participantsStarted 2019-10-09

Plain-language summary

This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (Parts A and B) * 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 * May have received prior anti-PD(L)1 therapy * Cohort 2: NSCLC-squamous (Parts A and B) * 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 actionable mutations are not eligible * No more than 1 prior line of cytotoxic chemotherapy for their advanced disease * Must have received prior anti-PD(L)1 therapy, unless contraindicated * Cohort 3: NSCLC-nonsquamous (Parts A and B) * Must have unresectable local…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Timeframe: From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months)

Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1

Timeframe: From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

Part B: Confirmed Prostate-Specific Antigen (PSA) Response Rate as Determined by Investigator According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria, for Prostate Cancer

Timeframe: From the first dose of study treatment up to the date of last response assessment (maximum up to 13.5 months)

Trial details

NCT IDNCT04032704

SponsorSeagen Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-28

Results submitted2024-11-21

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