Advanced Solid TumorPhase 1/2NCT07213830
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies
A Phase 1/2 study testing IPN01203 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Ipsen at 10 sites in 4 countries.
Trial summary
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- IPN01203
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 6 Feb 2026to 14 Jul 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and/or MRI.
- All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.
- Have a life expectancy for disease-related mortality, as evaluated by the investigator.
- Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Adequate haematologic and end organ function
- Participant is capable of giving signed informed consent as described in the protocol.
Who cannot join
- Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
- History of known autoimmune disease
- History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.
- History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional exclusion criteria include:
- Left ventricular ejection fraction <45%
Show all 23Show fewer
- QT interval corrected by Fridericia (QTcF) >470 ms (for women) and >450 ms (for men) or CS arrhythmias.
- History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
- Prior organ transplantation.
- Chronic or ongoing active infections within 4 weeks prior to Cycle1 Day1 (C1D1).
- Presence of hepatitis B surface antigen (HBsAg) [or hepatitis B core antibody (HBcAb)] at screening or within 3 months prior to the first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.
- Participants with known history of HIV infection are excluded from the study unless they meet the following criteria:
- Stable Antiretroviral Therapy: Participants must be on a stable antiretroviral therapy regimen for at least 4 weeks prior to enrolment.
- CD4+ T cell Count: Participants must have a CD4+ T cell count of at least 200 cells/µL.
- Viral Load: Participants must have an undetectable viral load (HIV RNA <50 copies/mL)
- No Opportunistic Infections: Participants must not have had any opportunistic infections or other human immunodeficiency virus (HIV)-related illness within the past 6 months Note: HIV testing will be performed in any countries where it is mandatory per local requirements.
- History of other malignancy within the last years.
- Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures per investigator including, but not limited to renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
- Treatment with >10 mg per day of prednisone (or equivalent) or other immune suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for participants who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
- Concurrent participation in another therapeutic treatment study.
- Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.
- For French participants only: participants are under court protection, not affiliated to a social security system or protected adults.
Trial locations and contacts
10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 4 countries
United States4 sites, 4 recruiting
- Recruiting
South Texas Accelerated Research Therapeutics (START) - Midwest
Grand Rapids, Michigan, 49546
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37205
- Recruiting
South Texas Accelerated Research Therapeutics (START) - San Antonio
San Antonio, Texas, 78229
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona
- Recruiting
NEXT Quiron-Barcelona
Barcelona
- Recruiting
Hospital Fundacion Jimenez Diaz
Madrid
- Recruiting
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid
Canada1 site, 1 recruiting
- Recruiting
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)
Villejuif
About this study
Official title: An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body.
Read more
There will be two parts to this study:
- Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203.
- Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability.
An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib.
Each part will consist of the following periods:
- A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
- A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first.
There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier.
In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- IPN01203
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPN01203Biological
Study intervention will be provided in a vial.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: Dose Escalation | Experimental | Participants will receive assigned dose level IPN01203 administered intravenously (IV). Receives: Biological: IPN01203 |
| Phase Ib: Dose Optimisation | Experimental | Participants will randomly receive one of the two doses of interest, determined at the end of Phase Ia, of IPN01203 administered intravenously (IV). Receives: Biological: IPN01203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with dose limiting toxicity (DLT)
Measured: Within 28 days of first dose
Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs).
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began
Measured: From the first IPN01203 administration to 90 days after the last dose.
Phase Ib: Objective Response Rate (ORR)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1.
Measured: At end of study (up to approximately 3 years)
Secondary outcomes (11)
Phase Ia: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203.
Measured: Up to 28 days after study drug administration.
Phase Ia: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203
Measured: Up to 28 days after study drug administration.
Phase Ia: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203.
Measured: Up to 28 days after study drug administration.
Phase Ia: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
Measured: From the first dose of study drug administration, at predefined intervals until the end of study (up to approximately 3 years)
Phase Ia: Objective response rate (ORR)
ORR is defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1.
Measured: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
DoR is defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first.
Measured: At end of study (up to approximately 3 years)
Phase Ib: Duration of stable disease (SD)
SD is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first, for participants with SD as best response, with a minimum SD duration of 8 weeks.
Measured: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
PFS is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first.
Measured: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
DCR is defined as the percentage of participants with BOR of CR, PR, or SD, as determined by investigator per RECIST version 1.1, from the first IPN01203 administration throughout the study.
Measured: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Time to response (TTR)
TTR is defined as the time between date of start of treatment until first documented response (CR or PR), as determined by investigator per RECIST version 1.1.
Measured: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
Measured: From predose to end of treatment (up to approximately 3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start6 Feb 2026
- Primary completion14 Jul 2032 (estimated)
- Study completion14 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1a is sequential assignment - non-randomized, single arm. Part 1b is randomized, two-arm, parallel design.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213830
- Sponsor's protocol ID
- CLIN-01203-450
- Other IDs
- 2025-522184-15-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies
- ClinicalTrials.gov ID
- NCT07213830
- Acronym / sponsor ID
- CLIN-01203-450
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 14 Jul 2032 (estimated)
- Study completion
- 14 Jul 2032 (estimated)
- First posted
- 9 Oct 2025 (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 purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body.
There will be two parts to this study:
- Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203.
- Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability.
An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib.
Each part will consist of the following periods:
- A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
- A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first.
There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier.
In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1a is sequential assignment - non-randomized, single arm. Part 1b is randomized, two-arm, parallel design.
| Arm | Type | Receives |
|---|---|---|
| Phase Ia: Dose Escalation | Experimental | Biological: IPN01203Participants will receive assigned dose level IPN01203 administered intravenously (IV). |
| Phase Ib: Dose Optimisation | Experimental | Biological: IPN01203Participants will randomly receive one of the two doses of interest, determined at the end of Phase Ia, of IPN01203 administered intravenously (IV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and/or MRI.
- All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.
- Have a life expectancy for disease-related mortality, as evaluated by the investigator.
Key exclusion criteria (23 listed)
- Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
- History of known autoimmune disease
- History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.
- History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional exclusion criteria include:
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 |
|---|---|---|
| IPN01203Study intervention will be provided in a vial. | Biological | Phase Ia: Dose Escalation, Phase Ib: Dose Optimisation |
Primary outcome
Percentage of participants with dose limiting toxicity (DLT)
Time frame: Within 28 days of first dose
Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs).
Time frame: From the first IPN01203 administration to 90 days after the last dose.
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began
Phase Ib: Objective Response Rate (ORR)
Time frame: At end of study (up to approximately 3 years)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1.
11 secondary outcomes
Phase Ia: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203.
Time frame: Up to 28 days after study drug administration.
Phase Ia: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203
Time frame: Up to 28 days after study drug administration.
Phase Ia: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203.
Time frame: Up to 28 days after study drug administration.
Phase Ia: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
Time frame: From the first dose of study drug administration, at predefined intervals until the end of study (up to approximately 3 years)
Phase Ia: Objective response rate (ORR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of stable disease (SD)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
Time frame: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Time to response (TTR)
Time frame: From the first IPN01203 administration throughout the study (up to approximately 3 years).
Phase Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.
Time frame: From predose to end of treatment (up to approximately 3 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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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.
Ipsen Medical Director study director
Ipsen
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPN01203 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Ipsen at 10 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 8 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain, Canada, France. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipsen Clinical Study Enquiries (See email, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with dose limiting toxicity (DLT) (time frame: Within 28 days of first dose). The study lists 3 primary outcomes in all. 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 3 Sep 2026.