Advanced Solid TumorPhase 1/2NCT05580770

Mirdametinib + BGB-3245 in Advanced Solid Tumors

A Phase 1/2 study testing Mirdametinib 2mg, BGB-3245 5mg and Mirdametinib 3mg in people with Advanced Solid Tumor, run by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany at 8 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor
What is being tested?: Mirdametinib 2mg, BGB-3245 5mg and Mirdametinib 3mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 8 sitesin 2 countries
Study dates: 3 Feb 2023to 15 Jan 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Able to provide informed consent
At least 18 years of age on day of signing ICF
Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
Part 2: oncogenic mutation or genomic aberration defined below:
Cohort A: cutaneous melanoma harboring NRAS mutations.

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Cohort B: non-small cell lung cancer (NSCLC) harboring a KRAS mutation.
Cohort C: NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutations or BRAF Fusion mutation.
Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
Measurable disease per RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Adequate organ function and no transfusion within 14 days of first dose

Who cannot join

Central Nervous System metastases, leptomeningeal carcinomatosis or untreated spinal cord compression
History of glaucoma
Active parathyroid disorder or history of malignancy associated hypercalcemia
Clinically significant cardiac disease within the past 6 months of signing ICF
History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these agents
Severe or uncontrolled systemic disease

Show all 15Show fewer

Inability to swallow oral medications
Clinically significant active infection (HIV, Hepatitis B or Hepatitis C)
History of or ongoing Immune Thrombocytopenia (ITP), Von Willebrand disease and/or other past or present bleeding disorders
Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
Systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose
Concomitant systemic or glucocorticoid therapy within 2 weeks before first dose
Concomitant medicines that are strong CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives before first dose
Live vaccine within 4 weeks before first dose

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States6 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06520
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

Australia2 sites

Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Calvary Mater Newcastle
Waratah, 2298

Other trials in Australia

About this study

Official title: A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors

A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.

Read the detailed description

The study will be conducted in two sequential parts: Part 1 dose escalation (Phase 1) and Part 2 dose expansion (Phase 2a).

Participants will receive mirdametinib and brimarafenib administered by mouth every day on a continuous schedule. Mirdametinib will be dosed twice a day (BID) and brimarafenib will be dosed once a day (QD). One treatment cycle will be 28 days.

Part 1 of the study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary evidence of anti-tumor efficacy. Part 1 will also identify the MTD and the RP2D for the combination of mirdametinib with brimarafenib.

Part 2 will confirm the safety, tolerability, efficacy, PK, and PDx for the combination of mirdametinib and brimarafenib. It will follow a parallel design and include one or more dose expansion cohorts, where each participant would be treated with the combination of mirdametinib and brimarafenib at the RP2D. It will begin after the RP2D for the combination of mirdametinib and brimarafenib is identified in Part 1. Part 2 may start either in parallel with, or after, the conduct and analysis of the PDx Expansion Cohort in Part 1.

Participants who experience a TEAE requiring treatment modification will be managed according to the applicable guidelines in the protocol.

Conditions: Advanced Solid Tumor
Being tested: Mirdametinib 2mg, BGB-3245 5mg, Mirdametinib 3mg, Mirdametinib 4mg, BGB-3245 10mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mirdametinib 2mgDrug
Also called PD-0325901
Mirdametinib 2mg administered orally
BGB-3245 5mgDrug
Also called Brimarafenib
BGB-3245 5mg administered orally
Mirdametinib 3mgDrug
Also called PD-0325901
Mirdametinib 3mg administered orally
Mirdametinib 4mgDrug
Also called PD-0325901
Mirdametinib 4mg administered orally
BGB-3245 10mgDrug
Also called Brimarafenib
BGB-3245 10mg administered orally
BGB-3245 20mgDrug
Also called Brimarafenib
BGB-3245 20mg administered orally

Study groups in NCT05580770
Study group	Role	What they receive
Phase 1 Dose Escalation, Cohort 1	Experimental	Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Receives: Drug: Mirdametinib 2mg; Drug: BGB-3245 5mg
Phase 1 Dose Escalation, Cohort 2	Experimental	Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Receives: Drug: Mirdametinib 2mg; Drug: BGB-3245 10mg
Phase 1 Dose Escalation, Cohort 3	Experimental	Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Receives: Drug: Mirdametinib 2mg; Drug: BGB-3245 20mg
Phase 1 Dose Escalation, Cohort 4	Experimental	Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Receives: Drug: Mirdametinib 3mg; Drug: BGB-3245 10mg
Phase 1 Dose Escalation, Cohort 5	Experimental	Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Receives: Drug: Mirdametinib 4mg; Drug: BGB-3245 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment Emergent Adverse Events
Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1.
Measured: All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
Maximum Tolerated Dose (Part 1 Only)
The maximum tolerated dose (MTD) for mirdametinib and BGB-3245 administered as a combination, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1.
Measured: Up to 18 months
Recommended Phase 2 Dose [RP2D] (Part 1 Only)
The recommended phase 2 dose (RP2D) for mirdametinib and BGB-3245 administered as a combination will be determined based on safety, tolerability, PK, preliminary anti-tumor efficacy, and other available data.
Measured: Up to 24 months
Objective Response Rate (Part 2 Only)
Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Objective Response Rate (ORR) defined as the proportion of participants with complete response (CR) + partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Measured: Up to 24 months

Secondary outcomes (3)

Objective Response Rate (Part 1 Only)
Preliminary anti-tumor efficacy of mirdametinib and BGB-3245 administered as a combination as assessed by CT or MRI. ORR defined as the proportion of participants with Complete Response (CR) + Partial Response (PR) using RECIST v1.1. Responses were as reported by the investigators.
Measured: From participants' date of first dose of study treatment through end of treatment, an average of 3.5 months
Duration of Response Rate
Duration of response rate in participants treated with the combination of mirdametinib and BGB-3245, defined as the time from response (CR + PR using RECIST v1.1) to disease progression and/or death.
Measured: Up to 36 months
Change in Plasma Concentrations of Mirdametinib and BGB-3245
To determine the PK of mirdametinib and BGB-3245 administered as a combination in the eligible participant population. Plasma concentrations of mirdametinib and BGB-3245 will be measured to evaluate systemic exposures (AUC, Cmax, Ctrough, and other PK parameters as data allow).
Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 202315 Jan 2025

First posted14 Oct 2022
Study start3 Feb 2023
Primary completion15 Jan 2025
Study completion15 Jan 2025

Why it stopped: Lack of tolerability of BGB-3245 (Brimarafenib) when given in combination with Mirdametinib

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorStudies 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: The study will be conducted in two sequential parts: Part 1 dose escalation (Phase 1) and Part 2 dose expansion (Phase 2a).
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05580770
Sponsor's protocol ID: MEKRAF-AST-101
Status last verified: Aug 2026
First submitted: 22 Sep 2022
Last updated: 20 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD supporting publicly available results will be evaluated for sharing.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05580770
Acronym / sponsor ID: MEKRAF-AST-101
Conditions: Advanced Solid Tumor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of tolerability of BGB-3245 (Brimarafenib) when given in combination with Mirdametinib
Enrolment: 23 participants (actual)
Lead sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 3 Feb 2023 (actual)
Primary completion: 15 Jan 2025 (actual)
Study completion: 15 Jan 2025 (actual)
First posted: 14 Oct 2022 (actual)
Results: Posted 1 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted in two sequential parts: Part 1 dose escalation (Phase 1) and Part 2 dose expansion (Phase 2a).

Participants who experience a TEAE requiring treatment modification will be managed according to the applicable guidelines in the protocol.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5
Model description: The study will be conducted in two sequential parts: Part 1 dose escalation (Phase 1) and Part 2 dose expansion (Phase 2a).

Arm	Type	Receives
Phase 1 Dose Escalation, Cohort 1	Experimental	Drug: Mirdametinib 2mg, Drug: BGB-3245 5mgParticipants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Phase 1 Dose Escalation, Cohort 2	Experimental	Drug: Mirdametinib 2mg, Drug: BGB-3245 10mgParticipants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Phase 1 Dose Escalation, Cohort 3	Experimental	Drug: Mirdametinib 2mg, Drug: BGB-3245 20mgParticipants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Phase 1 Dose Escalation, Cohort 4	Experimental	Drug: Mirdametinib 3mg, Drug: BGB-3245 10mgParticipants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Phase 1 Dose Escalation, Cohort 5	Experimental	Drug: Mirdametinib 4mg, Drug: BGB-3245 10mgParticipants with an oncogenic mutation or other genomic aberration of the MAPK pathway

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Able to provide informed consent
At least 18 years of age on day of signing ICF
Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
Part 2: oncogenic mutation or genomic aberration defined below:

Key exclusion criteria (15 listed)

Central Nervous System metastases, leptomeningeal carcinomatosis or untreated spinal cord compression
History of glaucoma
Active parathyroid disorder or history of malignancy associated hypercalcemia
Clinically significant cardiac disease within the past 6 months of signing ICF
History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these agents

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
Mirdametinib 2mgAlso: PD-0325901Mirdametinib 2mg administered orally	Drug	Phase 1 Dose Escalation, Cohort 1, Phase 1 Dose Escalation, Cohort 2, Phase 1 Dose Escalation, Cohort 3
BGB-3245 5mgAlso: BrimarafenibBGB-3245 5mg administered orally	Drug	Phase 1 Dose Escalation, Cohort 1
Mirdametinib 3mgAlso: PD-0325901Mirdametinib 3mg administered orally	Drug	Phase 1 Dose Escalation, Cohort 4
Mirdametinib 4mgAlso: PD-0325901Mirdametinib 4mg administered orally	Drug	Phase 1 Dose Escalation, Cohort 5
BGB-3245 10mgAlso: BrimarafenibBGB-3245 10mg administered orally	Drug	Phase 1 Dose Escalation, Cohort 2, Phase 1 Dose Escalation, Cohort 4, Phase 1 Dose Escalation, Cohort 5
BGB-3245 20mgAlso: BrimarafenibBGB-3245 20mg administered orally	Drug	Phase 1 Dose Escalation, Cohort 3

Primary outcome

Incidence of Treatment Emergent Adverse Events
Time frame: All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1.
Maximum Tolerated Dose (Part 1 Only)
Time frame: Up to 18 months
The maximum tolerated dose (MTD) for mirdametinib and BGB-3245 administered as a combination, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1.
Recommended Phase 2 Dose [RP2D] (Part 1 Only)
Time frame: Up to 24 months
The recommended phase 2 dose (RP2D) for mirdametinib and BGB-3245 administered as a combination will be determined based on safety, tolerability, PK, preliminary anti-tumor efficacy, and other available data.
Objective Response Rate (Part 2 Only)
Time frame: Up to 24 months
Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Objective Response Rate (ORR) defined as the proportion of participants with complete response (CR) + partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

3 secondary outcomes

Objective Response Rate (Part 1 Only)
Time frame: From participants' date of first dose of study treatment through end of treatment, an average of 3.5 months
Duration of Response Rate
Time frame: Up to 36 months
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Time frame: Up to 24 months

Results and safety

Results posted to the registry on 1 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1, Cohort 1 - Dose Escalation	3	3
Phase 1, Cohort 2 - Dose Escalation	7	3
Phase 1, Cohort 3 - Dose Escalation	6	1
Phase 1, Cohort 4 - Dose Escalation	4	3
Phase 1, Cohort 5 - Dose Escalation	3	1

Primary outcome: Incidence of Treatment Emergent Adverse Events

Time frame: All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).. Count of participants. Unit: Participants

Measure	Phase 1, Cohort 1 - Dose Escalation n = 3	Phase 1, Cohort 2 - Dose Escalation n = 7	Phase 1, Cohort 3 - Dose Escalation n = 6	Phase 1, Cohort 4 - Dose Escalation n = 4	Phase 1, Cohort 5 - Dose Escalation n = 3	Phase 1 Overall - Dose Escalation n = 23
With at least one TEAE	3	7	6	4	3	23
With at least one treatment-emergent SAE	2	3	5	3	3	16
With at least one study procedure related TEAE	0	1	0	0	0	1
With at least one TEAE leading to any treatment discontinuation	0	2	4	2	3	11
With at least one TEAE related to Mirdametinib	2	6	5	4	3	20
With at least one TEAE related to BGB-3245	3	6	5	4	3	21
With at least one TEAE leading to Mirdametinib dose reduction	1	2	1	1	0	5
With at least one TEAE leading to BGB-3245 dose reduction	0	2	1	1	0	4

Population analysed: Safety Population: All participants assigned to the study treatment and have taken at least one dose of study treatment (either Mirdametinib or BGB-3245).

Primary outcome: Maximum Tolerated Dose (Part 1 Only)

Time frame: Up to 18 months. Number. Unit: mg

Measure	Phase 1 Overall - Dose Escalation n = 23
Maximum Tolerated Dose: BGB-3245 (QD) when given in combination with mirdametinib	10
Maximum Tolerated Dose: Mirdametinib (BID) when given in combination with BGB-3245	3

Population analysed: Safety Population: All participants assigned to the study treatment and have taken at least one dose of study treatment (either Mirdametinib or BGB-3245).

Primary outcome: Recommended Phase 2 Dose [RP2D] (Part 1 Only)

Time frame: Up to 24 months. Count of participants. Unit: Participants

Measure	Phase 1 Overall - Dose Escalation n = 23
Value	NA

Population analysed: Due to study termination during Phase 1 dose escalation a recommended phase 2 dose was not confirmed

Primary outcome: Objective Response Rate (Part 2 Only)

Time frame: Up to 24 months

Population analysed: Due to study termination, no participants were enrolled in Phase 2 of the study

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, Cohort 1 - Dose Escalation	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Phase 1, Cohort 2 - Dose Escalation	3 of 7 (42.9%)	7 of 7 (100%)	1 of 7
Phase 1, Cohort 3 - Dose Escalation	5 of 6 (83.3%)	5 of 6 (83.3%)	0 of 6
Phase 1, Cohort 4 - Dose Escalation	3 of 4 (75%)	4 of 4 (100%)	1 of 4
Phase 1, Cohort 5 - Dose Escalation	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Phase 1 Overall	16 of 23 (69.6%)	22 of 23 (95.7%)	3 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD supporting publicly available results will be evaluated for sharing.

Related trials for Advanced Solid Tumor

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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.

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 15 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Australia. 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?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Treatment Emergent Adverse Events (time frame: All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).). 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?

On the ClinicalTrials.gov record for NCT05580770.

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 Aug 2026.