Recent Updates
Recently added Catalysts

Loncastuximab tesirine 150 µg/Kg

Phase 2

Marginal Zone Lymphoma | Small molecule | Oncology |ADC Therapeutics SA|Last Updated: Sep 30, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Loncastuximab tesirine 150 µg/Kg · 1 trial · 1 indication

Phase 2 1
NCT05296070Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone LymphomaMarginal Zone Lymphoma
RECRUITING50 Analytics
PHASE2RECRUITING
Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
Marginal Zone LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months
6 months.

CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET (Positron emission tomography)-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.

Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 12 months
12 months.

CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.

Secondary Endpoints

Partial Response rate at 6 months
6 months
Partial Response rate at 12 months
12 months
Overall response rate (ORR) at 6 months
6 months
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Loncastuximab tesirine Cycles 1-6EXPERIMENTALPatients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle. The total duration of treatment is approximately 18 weeks (4.5 months)

Interventions

NameTypeDescription
Loncastuximab tesirine 150 µg/KgDRUGParticipants will be treated with loncastuximab tesirine at a dose of 150 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 1 - 2.
Loncastuximab tesirine 75µg/KgDRUGParticipants will be treated with loncastuximab tesirine at a dose of 75 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 3 - 6.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Men and women, aged 18 years or older. 2. Histologically confirmed MZL, including extranodal, nodal, and splenic subtypes. 3. Previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody (cluster of differentiation antigen 20) (either as mo...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Loncastuximab tesirine 150 µg/Kg

What is Loncastuximab tesirine 150 µg/Kg used for?

Loncastuximab tesirine 150 µg/Kg is an investigational oncology drug being studied for the treatment of Marginal Zone Lymphoma, a type of non-Hodgkin lymphoma. It is currently in Phase 2 clinical development for this indication.

What does Loncastuximab tesirine 150 µg/Kg target?

Loncastuximab tesirine 150 µg/Kg is an antibody-drug conjugate that targets CD19, a protein expressed on B-cells. It delivers a cytotoxic payload to CD19-positive cells, which is relevant for treating B-cell malignancies like Marginal Zone Lymphoma.

Who makes Loncastuximab tesirine 150 µg/Kg?

Loncastuximab tesirine 150 µg/Kg is being developed by ADC Therapeutics SA, a biopharmaceutical company focused on oncology. The company's stock is traded under the ticker ADCT.

What phase is Loncastuximab tesirine 150 µg/Kg in?

Loncastuximab tesirine 150 µg/Kg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any use.

What clinical trials is Loncastuximab tesirine 150 µg/Kg in?

Loncastuximab tesirine 150 µg/Kg is being evaluated in a Phase 2 clinical trial with the identifier NCT05296070. This open-label, uncontrolled study is recruiting patients with relapsed or refractory Marginal Zone Lymphoma in the United States.

Is Loncastuximab tesirine 150 µg/Kg the same as ADCT-402?

Yes, Loncastuximab tesirine 150 µg/Kg is also known as ADCT-402. The clinical trial NCT05296070 refers to the drug as ADCT-402, and it is being studied in patients with Marginal Zone Lymphoma.