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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

Phase 1/2 Study of Zilovertamab Vedotin in Pediatric and Young Adult Participants

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Pending

June. 26, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

For hematological malignancies: Confirmed diagnosis of B-precursor B-cell acute lymphoblastic leukemia (B-ALL) or Diffuse large B-cell lymphoma(DLBCL)/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.
For solid tumor malignancies: Histologically confirmed diagnosis of Neuroblastoma or Ewing sarcoma.

- History of solid organ transplant.
- Clinically significant (ie, active) cardiovascular disease.
- Known history of liver cirrhosis.
- Ongoing Grade >1 peripheral neuropathy.
- Demyelinating form of Charcot-Marie-Tooth disease.
- Diagnosed with Down syndrome.
- Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
- History of human immunodeficiency virus (HIV) infection.
- Contraindication or hypersensitivity to any of the study intervention components.
- Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
- 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).
- 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
- 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).
- 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.
- Known additional malignancy that is progressing or has required active treatment within the past 1 year.
- Active infection requiring systemic therapy.
- 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.

Both

In participants with B-ALL, DLBCL/Burkitt lymphoma, Neuroblastoma or Ewing sarcoma

Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

Part 1:
- Dose-limiting toxicity
- AEs
- Discontinuation of study intervention due to AEs
- Dose modification due to AEs
Part 1 and Part 2:
- Objective Response (OR) for participants with B-ALL
- OR for participants with DLBCL/Burkitt lymphoma, Neuroblastoma, and Ewing sarcoma

Part 1 and Part 2:
- Pharmacokinetics (PK) parameters
- Antidrug Antibodies (ADAs)
- Duration of Response (DOR)
- The proportion of participants by tumor type who become eligible for transplant/CAR-T while on treatment with zilovertamab vedotin
Part 2:
- AEs
- Discontinuation of study intervention due to AEs
- Dose modification due to AEs

+81-3-3542-2511

Yes

https://engagezone.msd.com/

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