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Monoclonal Antibodies
Loncastuximab Tesirine for Lymphoma
Phase 1
Recruiting
Research Sponsored by ADC Therapeutics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Study Summary
This trial will study the best dose of a drug for people with advanced lymphomas and liver problems.
Who is the study for?
This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma, who've had at least one treatment. It's specifically for those with liver issues: normal function, moderate impairment (bilirubin >1.5-3x normal), or severe impairment (bilirubin >3x). Participants must be able to perform daily activities with little to some difficulty and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the drug Loncastuximab Tesirine in patients with certain types of lymphoma and varying levels of liver health. The goal is to find the safest and most effective dose for those with moderate to severe liver problems.See study design
What are the potential side effects?
While not specified here, common side effects from drugs like Loncastuximab Tesirine may include fatigue, nausea, fever, rash, and potential changes in blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Moderate or Severe Hepatic Impairment Who Experience a Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Accumulation Index (AI) of Loncastuximab Tesirine and SG3199 in Serum
Apparent Clearance (CL) of Loncastuximab Tesirine and SG3199 in Serum
Apparent Steady-state Volume of Distribution (Vss) of Loncastuximab Tesirine and SG3199 in Serum
+22 moreSide effects data
From 2022 Phase 2 trial • 145 Patients • NCT0358946942%
Gamma-glutamyltransferase increased
40%
Neutropenia
33%
Thrombocytopenia
28%
Fatigue
26%
Anaemia
23%
Nausea
22%
Cough
20%
Blood alkaline phosphatase increased
19%
Oedema peripheral
17%
Diarrhoea
17%
Pyrexia
16%
Aspartate aminotransferase increased
16%
Hypokalaemia
16%
Hypophosphataemia
15%
Alanine aminotransferase increased
15%
Decreased appetite
14%
Hypomagnesaemia
14%
Leukopenia
13%
Vomiting
13%
Rash
13%
Pruritus
12%
Constipation
12%
Dyspnoea
11%
Abdominal pain
11%
Insomnia
10%
Asthenia
10%
Headache
10%
Erythema
10%
Photosensitivity reaction
10%
Pleural effusion
8%
Hypocalcaemia
8%
Tachycardia
8%
Hyperglycaemia
8%
Lymphopenia
7%
Weight increased
7%
Hypotension
6%
Nasal congestion
6%
Hyponatraemia
6%
Back pain
6%
Pain in extremity
6%
Neck pain
6%
Dizziness
6%
Rash maculo-papular
6%
Hypertension
4%
Hypercalcaemia
3%
Febrile neutropenia
1%
Haematoma
1%
Syncope
1%
Confusional state
1%
Embolism
1%
Mental status changes
1%
Intentional self-injury
1%
Haemoptysis
1%
Thrombosis
1%
Deep vein thrombosis
1%
Postoperative hypotension
1%
Pneumonia fungal
1%
Rhinovirus infection
1%
Diffuse large B-cell lymphoma
1%
Acute kidney injury
1%
Ureterolithiasis
1%
Pleuritic pain
1%
Pneumonitis
1%
Metapneumovirus infection
1%
Lung infection
1%
Facial nerve disorder
1%
Psychomotor skills impaired
1%
Hydronephrosis
1%
Pericardial effusion
1%
Pericarditis
1%
Ascites
1%
Dysphagia
1%
Intestinal obstruction
1%
Small intestinal obstruction
1%
Small intestinal perforation
1%
Non-cardiac chest pain
1%
Disease progression
1%
Face oedema
1%
Pain
1%
Pneumonia
1%
Escherichia sepsis
1%
Influenza
1%
Klebsiella infection
1%
Sepsis
1%
Septic shock
1%
Soft tissue infection
1%
Urinary tract infection bacterial
1%
Fall
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Loncastuximab Tesirine
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive loncastuximab tesirine in a standard 3+3 dose-escalation design. Initial dose will be 0.09 mg/kg Q3W for two cycles, then 0.045 mg/kg Q3W for subsequent cycles (1 cycle = 21 days). The highest dose possibly administered will be 0.15 mg/kg Q3W.
Participants who have a toxicity meeting the criteria for dose reduction will have subsequent doses reduced by 50%. If the toxicity recurs, subsequent doses must be reduced by an additional 50%. A maximum of 2 dose reductions are allowed. Participants who have a toxicity meeting the criteria for dose reduction following Cycle 2 will receive the protocol-specified dose of 50% of initiate dose for Cycle 3, i.e., they will not have an additional dose reduction for Cycle 3.
Group II: Arm B: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive loncastuximab tesirine in a standard 3+3 dose-escalation design. Initial dose will be 0.09 mg/kg Q3W for two cycles, then 0.045 mg/kg Q3W for subsequent cycles (1 cycle = 21 days). The highest dose possibly administered will be 0.15 mg/kg Q3W.
Participants who have a toxicity meeting the criteria for dose reduction will have subsequent doses reduced by 50%. If the toxicity recurs, subsequent doses must be reduced by an additional 50%. A maximum of 2 dose reductions are allowed. Participants who have a toxicity meeting the criteria for dose reduction following Cycle 2 will receive the protocol-specified dose of 50% of initiate dose for Cycle 3, i.e., they will not have an additional dose reduction for Cycle 3.
Group III: Arm A: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive loncastuximab tesirine 0.15 mg/kg once every 3 weeks (Q3W) for two cycles, then 0.075 mg/kg Q3W for subsequent cycles (1 cycle = 21 days).
Participants who have a toxicity meeting the criteria for dose reduction will have subsequent doses reduced by 50%. If the toxicity recurs, subsequent doses must be reduced by an additional 50%. A maximum of 2 dose reductions are allowed. Participants who have a toxicity meeting the criteria for dose reduction following Cycle 2 will receive the protocol-specified dose of 50% of initiate dose for Cycle 3, i.e., they will not have an additional dose reduction for Cycle 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
ADC Therapeutics S.A.Lead Sponsor
28 Previous Clinical Trials
2,241 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently open to enrolling new participants?
"The clinicaltrials.gov portal reveals that this research is currently actively searching for participants, with initial posting taking place on August 28th 2023 and last updated November 6th 2023."
Answered by AI
How many participants are currently being monitored in this medical experiment?
"Affirmative, clinicaltrials.gov confirms that this medical study is presently accepting volunteers; it was initially posted on August 28th 2023 and updated most recently on November 6th 2023. The team managing the trial are searching for 56 participants from a single site."
Answered by AI
Has the FDA given approval for Arm B: Moderate Hepatic Impairment?
"The safety of Arm B: Moderate Hepatic Impairment has been judged to be a 1, as there is only limited evidence indicating its efficacy and no considerable data demonstrating it's safeguard."
Answered by AI
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