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Loncastuximab tesirine and rituximab

Phase 1

Central Nervous System Lymphoma | Small molecule | Oncology |ADC Therapeutics SA|Last Updated: Dec 3, 2025

Target and mechanism

ModalitySmall molecule

Also known as Loncastuximab Tesirine and Acalabrutinib, Loncastuximab Tesirine, Loncastuximab tesirine, Loncastuximab tesirine and rituximab (Lonca-R)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Loncastuximab tesirine and rituximab · 1 trial · 1 indication

Phase 1 1
NCT06607549Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)Central Nervous System Lymphoma
RECRUITING12 Analytics
PHASE1RECRUITING
Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)
Central Nervous System LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

A safe and tolerable dose of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
5 years

Maximum Tolerated Dose (MTD): MTD is defined as the highest dose under consideration that has an estimated DLT probability below 25% based upon the Bayesian optimal interval design. The MTD will be decided based on the BOIN decision rules set for phase 1a portion of the study.

Secondary Endpoints

To assess best overall response rate (ORR) following lonca-R
6 months
To assess best complete response (CR) rate following lonca-R.
6 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment: All PatientsEXPERIMENTALThis study has two main goals: Goal 1: The study will investigate the safety and tolerability of loncastuximab tesirine and rituximab (lonca-R). Goal 2: The study will determine the maximum tolerated dose of lonca-R.

Interventions

NameTypeDescription
Loncastuximab tesirine and rituximab (Lonca-R)DRUGPatients will receive stereotactic radiosurgery (SRS) followed by a brain MRI approx. 3 weeks after SRS. This will be followed by loncastuximab tesirine and rituximab administered intravenously for a total of 6 cycles (every 21 days).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant aged ≥ 18 years * ECOG Performance Status ≤ 3 * Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either: * Relapsed or refractory disease with at least 1 prior therapy OR * Ineligible fo...

Countries:United States
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Frequently asked questions about Loncastuximab tesirine and rituximab

What is Loncastuximab Tesirine used for?

Loncastuximab Tesirine is an investigational oncology drug being studied for post-transplant lymphoproliferative disorder, B-cell non-Hodgkin lymphoma, refractory diffuse large B-cell lymphoma, central nervous system lymphoma, and relapsed diffuse large B-cell lymphoma. It is in Phase 1 clinical development and is not FDA approved.

Who makes Loncastuximab Tesirine?

Loncastuximab Tesirine is developed by ADC Therapeutics SA, traded on the New York Stock Exchange under the ticker ADCT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various B-cell malignancies.

What phase is Loncastuximab Tesirine in?

Loncastuximab Tesirine is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The drug is being studied in combination with other anti-cancer agents for relapsed or refractory B-cell non-Hodgkin lymphoma.

What clinical trials is Loncastuximab Tesirine in?

Loncastuximab Tesirine is being evaluated in several trials, including NCT03589469 (completed Phase 2 in relapsed/refractory DLBCL), NCT04970901 (recruiting Phase 1 LOTIS-7 in B-cell NHL), NCT06788964 (recruiting Phase 2 CORAL bridging therapy), and NCT07573436 (not yet recruiting Phase 1 PLUTO in post-transplant lymphoproliferative disorder).

Is Loncastuximab Tesirine the same as Loncastuximab Tesirine and Acalabrutinib?

Loncastuximab Tesirine is also known as Loncastuximab Tesirine and Acalabrutinib, Loncastuximab tesirine and rituximab (Lonca-R), and Loncastuximab tesirine and rituximab. These names refer to the drug in combination with other agents, while Loncastuximab Tesirine alone is the single-agent form.

What does Loncastuximab Tesirine target?

Loncastuximab Tesirine is a small molecule oncology drug. The specific molecular target is not disclosed in the available information, but it is being studied in B-cell malignancies including diffuse large B-cell lymphoma and post-transplant lymphoproliferative disorder.