MelanomaPhase 1/2NCT06305247
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
A Phase 1/2 study testing IPN01194 in people with Melanoma and Head and Neck Squamous Cell Carcinoma, run by Ipsen at 12 sites in 3 countries.
Trial summary
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Head and Neck Squamous Cell Carcinoma, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- IPN01194
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 3 Apr 2024to 20 Mar 2028
- 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
- Participants must be ≥18 years of age
- Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
- Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1.
- Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening
- 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 trials.
Who cannot join
- Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
- Any evidence of severe active infection or inflammatory condition.
- Non-adequate cardiac function
- Have one or more of study defined ophthalmological findings/conditions
- Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
- Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.
Show all 23Show fewer
- Known second malignancy within the last 2 years prior to first dose of study intervention..
- Major surgery within 28 days prior to first dose of study intervention.
- Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
- Active brain metastases or leptomeningeal metastases
- Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days.
- Live vaccine(s) within 28 days prior to first dose of study intervention
- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
- Treatment with medications that prolong the QT/QTc interval.
- Treatment with strong and moderate CYP3A4 inducers
- Treatment with strong or moderate inhibitors of CYP3A4
- Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
- Non-adequate bone marrow function
- Non-adequate renal function
- Non-adequate hepatic function
- Non adequate coagulation function.
- Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
- Sensitivity to IPN01194 or any of its components.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States5 sites
Virginia Cancer Specialist
Fairfax, Virginia, 22031
The Angeles Clinic and Research Institute - California
Los Angeles, California, 90025
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, 37203
Yale Cancer Center - New Heaven
New Haven, Connecticut, 06510
UC San Diego Health System - La Jolla
San Diego, California, 92037
France4 sites
Centre Léon Bérard - Lyon
Lyon
Paris Saint-Louis
Paris
Institut de Cancerologie de l'Ouest (St-Herblain)
Saint-Herblain
IGR-Villejuif
Villejuif
Spain3 sites
Barcelona - Val D'Hebron
Barcelona
Fundacion Jimenez Diaz - Madrid
Madrid
M.D. Anderson Cancer Center Madrid
Madrid
About this study
Official title: An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
In this study, all participants will receive the study drug, which will be taken by mouth (orally).
Read the detailed description
The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.
The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
- A period to assess eligibility (screening period) that will take up to 28 days.
- A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug.
- A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.
Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.
If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.
- Conditions
- Melanoma, Head and Neck Squamous Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Solid Tumor
- Being tested
- IPN01194
- Medical subject headings
- Melanoma, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPN01194Drug
IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1).
Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.
IPN01194Drug
All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I.
Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision
| Study group | Role | What they receive |
|---|---|---|
| Phase I (Dose Escalation with Backfilling) | Experimental | Nine dose levels are planned to be tested. Receives: Drug: IPN01194 |
| Phase IIa (Cohort Expansion) | Experimental | Study intervention will be administered at one of two doses of interest determined at the end of Phase I. Receives: Drug: IPN01194 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Percentage of participants with dose limiting toxicity (DLT)
Measured: Within 28 days of first dose
Phase 1: 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.
Measured: At 30 days following the last administration of study intervention
Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations
Measured: At 30 days following the last administration of study intervention
Phase 2a: Objective response rate (ORR)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.
Measured: At end of treatment (up to approximately 32 months)
Secondary outcomes (14)
Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194
Measured: At Day 1 and Day 15.
Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194
Measured: At Day 1 and Day 15.
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
AUCtau is defined as the concentration of drug over one dosing interval.
Measured: At Day 1 and Day 15.
Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state
Measured: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Prolongation of corrected QT interval (QTc)
Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure.
Measured: Within 28 days of first dose
Phase 1: Objective response rate (ORR)
The ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
Measured: At end of treatment (up to approximately 32 months)
Phase 2a: Duration of response (DoR)
Defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1
Measured: From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Progression-free survival (PFS)
PFS is defined as the time from the date of randomisation to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1.
Measured: From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: PFS rate at 4 months
Measured: From randomisation to 4 months
Phase 2a: Disease control rate (DCR)
DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1.
Measured: At end of treatment (up to approximately 32 months)
Phase 2a: Percentage of participants with TEAEs and TE SAEs
Measured: At end of treatment (up to approximately 32 months)
Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations
Measured: At end of treatment (up to approximately 32 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start3 Apr 2024
- Primary completion20 Mar 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Phase I is a dose escalation with backfill in participants with selected MAPKm advanced solid tumours. Phase IIa (cohort expansion) is an open label randomised study.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT06305247
- Sponsor's protocol ID
- CLIN-01194-450
- Other IDs
- 2023-506228-10-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06305247
- Acronym / sponsor ID
- CLIN-01194-450
- Conditions
- Melanoma, Head and Neck Squamous Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 12 Mar 2024 (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 the study drug, IPN01194 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
In this study, all participants will receive the study drug, which will be taken by mouth (orally).
Detailed description
The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.
The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
- A period to assess eligibility (screening period) that will take up to 28 days.
- A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug.
- A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.
Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.
If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I is a dose escalation with backfill in participants with selected MAPKm advanced solid tumours. Phase IIa (cohort expansion) is an open label randomised study.
| Arm | Type | Receives |
|---|---|---|
| Phase I (Dose Escalation with Backfilling) | Experimental | Drug: IPN01194Nine dose levels are planned to be tested. |
| Phase IIa (Cohort Expansion) | Experimental | Drug: IPN01194Study intervention will be administered at one of two doses of interest determined at the end of Phase I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be ≥18 years of age
- Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
- Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1.
Key exclusion criteria (23 listed)
- Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
- Any evidence of severe active infection or inflammatory condition.
- Non-adequate cardiac function
- Have one or more of study defined ophthalmological findings/conditions
- Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
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 |
|---|---|---|
| IPN01194IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1). Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision. | Drug | Phase I (Dose Escalation with Backfilling) |
| IPN01194All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I. Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision | Drug | Phase IIa (Cohort Expansion) |
Primary outcome
Phase 1: Percentage of participants with dose limiting toxicity (DLT)
Time frame: Within 28 days of first dose
Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)
Time frame: At 30 days following the last administration of study intervention
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.
Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations
Time frame: At 30 days following the last administration of study intervention
Phase 2a: Objective response rate (ORR)
Time frame: At end of treatment (up to approximately 32 months)
Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.
14 secondary outcomes
Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194
Time frame: At Day 1 and Day 15.
Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194
Time frame: At Day 1 and Day 15.
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
Time frame: At Day 1 and Day 15.
Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state
Time frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state
Time frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state
Time frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Prolongation of corrected QT interval (QTc)
Time frame: Within 28 days of first dose
Phase 1: Objective response rate (ORR)
Time frame: At end of treatment (up to approximately 32 months)
Phase 2a: Duration of response (DoR)
Time frame: From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Progression-free survival (PFS)
Time frame: From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: PFS rate at 4 months
Time frame: From randomisation to 4 months
Phase 2a: Disease control rate (DCR)
Time frame: At end of treatment (up to approximately 32 months)
Phase 2a: Percentage of participants with TEAEs and TE SAEs
Time frame: At end of treatment (up to approximately 32 months)
Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations
Time frame: At end of treatment (up to approximately 32 months)
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 30 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.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Ipsen Medical Director study director
Ipsen
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPN01194 in people with Melanoma and Head and Neck Squamous Cell Carcinoma, run by Ipsen at 12 sites in 3 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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 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 12 sites in United States, France, Spain. 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?
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?
Phase 1: Percentage of participants with dose limiting toxicity (DLT) (time frame: Within 28 days of first dose). The study lists 4 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 30 Sep 2026.