Diffuse Large B-Cell LymphomaPhase 1NCT05660395
A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
A Phase 1 study testing Loncastuximab Tesirine in people with Diffuse Large B-Cell Lymphoma and High-grade B-cell Lymphoma, run by ADC Therapeutics S.A. at 14 sites in 4 countries.
Trial summary
The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma
- What is being tested?
- Loncastuximab Tesirine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 28 Jul 2023to 25 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 years or older
- Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen
- Measurable disease as defined by the 2014 Lugano Classification
- Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification:
- Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN)
- Arm B Moderate hepatic impairment: bilirubin > 1.5 × to 3 × ULN (any AST)
Show all 10Show fewer
- Arm C Severe hepatic impairment: bilirubin > 3 × ULN (any AST)
- ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment
- Adequate organ function
- Women of childbearing potential (WOCBP)* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug.
Who cannot join
- Previous therapy with loncastuximab tesirine
- Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)
- Human immunodeficiency virus (HIV) seropositive
- Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
- Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
Show all 10Show fewer
- Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease
- Breastfeeding or pregnant
- Significant medical comorbidities
- Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Brazil6 sites
Hospital Sírio-Libanês - Brasília
Brasília, 70200-730
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, 90110-270
Hospital Sírio-Libanês - São Paulo
São Paulo, 01308-050
A Beneficência Portuguesa de São Paulo - Unidade Mirant
São Paulo, 01323-030
Hospital 9 de Julho
São Paulo, 01409-002
Albert Einstein Israelite Hospital
São Paulo, 05652-900
South Korea5 sites
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi, 41944
Dong-A University Hospital
Pusan, Gyeongsangnam-do, 602-812
Korea University Anam Hospital
Seoul, Seongbuk District, 02841
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080
Severance Hospital
Seoul, Seoul Teugbyeolsi, 03722
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan 112
United States1 site
The Oncology Institute of Hope & Innovation - Lynwood
Lynwood, California, 90262
About this study
Official title: A Phase 1b Open-Label Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.
- Being tested
- Loncastuximab Tesirine
- Keywords
- Loncastuximab Tesirine, Lymphoma, DLBCL, HGBCL, Hepatic Impairment
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab TesirineDrug
Also called Zynlonta, ADCT-402
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Normal Hepatic Function | Experimental | 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. Receives: Drug: Loncastuximab Tesirine |
| Arm B: Moderate Hepatic Impairment | Experimental | 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. Receives: Drug: Loncastuximab Tesirine |
| Arm C: Severe Hepatic Impairment | Experimental | 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. Receives: Drug: Loncastuximab Tesirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Moderate or Severe Hepatic Impairment Who Experience a Dose-Limiting Toxicity (DLT)
Measured: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days
Secondary outcomes (25)
Maximum Concentration (Cmax) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Time to Cmax (Tmax) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Apparent Terminal Elimination Half-life (Thalf) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Apparent Clearance (CL) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Apparent Steady-state Volume of Distribution (Vss) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Accumulation Index (AI) of Loncastuximab Tesirine and SG3199 in Serum
Measured: Day 1 up to 1 year
Number of Participants Who Experience an Adverse Event (AE)
Measured: Up to approximately 3 years
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Measured: Up to approximately 1 year
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay
Measured: Up to approximately 1 year
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption
Measured: Up to approximately 1 year
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction
Measured: Up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Values
Measured: Baseline up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Signs
Measured: Baseline up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured: Baseline up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiogram (ECG) Measurements
Measured: Baseline up to approximately 1 year
Overall Response Rate (ORR)
Measured: Up to approximately 3 years
Duration of Response (DOR)
Measured: Up to approximately 3 years
Complete Response (CR) Rate
Measured: Up to approximately 3 years
Progression-Free Survival (PFS)
Measured: Up to approximately 3 years
Relapse-Free Survival (RFS)
Measured: Up to approximately 3 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Number of Participants With Anti-drug Antibody (ADA) Titers to Loncastuximab Tesirine
Measured: Day 1 up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start28 Jul 2023
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Why it stopped: This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADC Therapeutics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660395
- Sponsor's protocol ID
- ADCT-402-107
- Other IDs
- 2021-005209-29
- Status last verified
- Jul 2026
- First submitted
- 13 Dec 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
- ClinicalTrials.gov ID
- NCT05660395
- Acronym / sponsor ID
- ADCT-402-107
- Keywords
- Loncastuximab Tesirine, Lymphoma, DLBCL, HGBCL, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ADC Therapeutics S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Normal Hepatic Function | Experimental | Drug: Loncastuximab TesirineParticipants 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. |
| Arm B: Moderate Hepatic Impairment | Experimental | Drug: Loncastuximab TesirineParticipants 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. |
| Arm C: Severe Hepatic Impairment | Experimental | Drug: Loncastuximab TesirineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants aged 18 years or older
- Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen
- Measurable disease as defined by the 2014 Lugano Classification
- Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification:
- ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment
Key exclusion criteria (10 listed)
- Previous therapy with loncastuximab tesirine
- Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)
- Human immunodeficiency virus (HIV) seropositive
- Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
- Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loncastuximab TesirineAlso: Zynlonta, ADCT-402Intravenous (IV) Infusion | Drug | Arm A: Normal Hepatic Function, Arm B: Moderate Hepatic Impairment, Arm C: Severe Hepatic Impairment |
Primary outcome
Number of Participants with Moderate or Severe Hepatic Impairment Who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days
25 secondary outcomes
Maximum Concentration (Cmax) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Time to Cmax (Tmax) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Apparent Terminal Elimination Half-life (Thalf) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Apparent Clearance (CL) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Apparent Steady-state Volume of Distribution (Vss) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Accumulation Index (AI) of Loncastuximab Tesirine and SG3199 in Serum
Time frame: Day 1 up to 1 year
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 3 years
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Up to approximately 1 year
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay
Time frame: Up to approximately 1 year
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption
Time frame: Up to approximately 1 year
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction
Time frame: Up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Values
Time frame: Baseline up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline up to approximately 1 year
Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiogram (ECG) Measurements
Time frame: Baseline up to approximately 1 year
Overall Response Rate (ORR)
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Time frame: Up to approximately 3 years
Complete Response (CR) Rate
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 3 years
Relapse-Free Survival (RFS)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Number of Participants With Anti-drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time frame: Day 1 up to 1 year
Results and safety
The study was stopped early (reason given: This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Loncastuximab Tesirine in people with Diffuse Large B-Cell Lymphoma and High-grade B-cell Lymphoma, run by ADC Therapeutics S.A. at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil, South Korea, Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Moderate or Severe Hepatic Impairment Who Experience a Dose-Limiting Toxicity (DLT) (time frame: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.