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LIGHTBEAM-U01-Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors.
EU CTIS ID: 2023-507178-41-00
What this study is testing
1. Part 1: To evaluate the safety and tolerability of zilovertamab vedotin monotherapy in participants from 1 to <18 years of age 2. Part 1 and Part 2: To evaluate preliminary antitumor activity of zilovertamab vedotin monotherapy per investigator assessment in participants from birth to <18 years of age for B-ALL, DLBCL/Burkitt lymphoma, and neuroblastoma, and from birth to 25 years for Ewing sarcoma
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues (As of protocol Amendment 4, in countries in the European Economic Area [EEA], the substudy will not enroll participants with hematological malignancies)
- For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma (As of protocol Amendment 4, in countries in the European Economic Area [EEA], the substudy will only enroll participants with diagnosis of Ewing sarcoma)
You likely can't join if
- Has history of solid organ transplant.
- Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
- Has ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).
- Has received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
See the full eligibility criteria
- For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues (As of protocol Amendment 4, in countries in the European Economic Area [EEA], the substudy will not enroll participants with hematological malignancies)
- For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma (As of protocol Amendment 4, in countries in the European Economic Area [EEA], the substudy will only enroll participants with diagnosis of Ewing sarcoma)
- Has history of solid organ transplant.
- Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
- Has ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).
- Has received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
- Has active infection requiring systemic therapy.
- Has known history of Hepatitis B or known active Hepatitis C virus infection.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
- Has clinically significant (ie, active) cardiovascular disease.
- Known history of liver cirrhosis.
- Has ongoing Grade >1 peripheral neuropathy.
- Has demyelinating form of Charcot-Marie-Tooth disease.
- Has been diagnosed with Down syndrome.
- Has ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
- Has history of human immunodeficiency virus (HIV) infection.
- Has contraindication or hypersensitivity to any of the study intervention components.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Canada
- Turkey
- Colombia
- United Kingdom
- Israel
- Brazil
- United States
- Mexico
- Taiwan
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Canada; Turkey; Colombia; United Kingdom; Israel and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.