Solid Tumor, AdultPhase 1NCT05381909
A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors
A Phase 1 study testing BGB-24714, Paclitaxel and Carboplatin in people with Solid Tumor, Adult, run by BeiGene at 34 sites in 5 countries.
Trial summary
This study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- BGB-24714, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 34 sitesin 5 countries
- Study dates
- 6 Jul 2022to 25 Jul 2025
- 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
None listed.
Who cannot join
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
- Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).
- Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.
- NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
United States17 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mary Crowley Cancer Research
Dallas, Texas, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7208
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-2013
Next Virginia
Fairfax, Virginia, 22031
Banner Md Anderson Cancer Center
Gilbert, Arizona, 85234-2165
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology)
Houston, Texas, 77030-4000
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309
Intermountain Healthcare
Salt Lake City, Utah, 84143
Florida Cancer Specialist (Scri) Sarasota
Sarasota, Florida, 34232
University of Washington
Seattle, Washington, 98195
Sanford Cancer Center
Sioux Falls, South Dakota, 57104-4663
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-2108
Scri Florida Cancer Specialists North
St. Petersburg, Florida, 33705-1449
Scri Florida Cancer Specialist East
West Palm Beach, Florida, 33401-3406
Australia6 sites
Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086
Austin Health
Heidelberg, Victoria, VIC 3084
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, QLD 4101
Sunshine Hospital
St Albans, Victoria, VIC 3021
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
China5 sites
Hunan Cancer Hospital
Changsha, Hunan, 410013
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Shandong Provincial Hospital
Jinan, Shandong, 250021
Shandong Cancer Hospital
Jinan, Shandong, 250117
Henan Cancer Hospital
Zhengzhou, Henan, 450000
South Korea5 sites
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, 21565
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
About this study
Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and With Combination Therapies in Patients With Solid Tumors
This study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.
- Conditions
- Solid Tumor, Adult
- Being tested
- BGB-24714, Paclitaxel, Carboplatin, Docetaxel
- Keywords
- Solid tumors, Advanced Solid Tumors, Metastatic Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-24714Drug
administered orally
PaclitaxelDrug
administered intravenously
CarboplatinDrug
administered intravenously
DocetaxelDrug
administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation Part A | Experimental | Participants will receive escalating doses of BGB-24714 as monotherapy Receives: Drug: BGB-24714 |
| Phase 1a: Dose Escalation Part B | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel Receives: Drug: BGB-24714; Drug: Paclitaxel |
| Phase 1a: Dose Escalation Part C | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Receives: Drug: BGB-24714; Drug: Paclitaxel; Drug: Carboplatin |
| Phase 1a: Dose Escalation Part D | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Receives: Drug: BGB-24714; Drug: Paclitaxel; Drug: Carboplatin |
| Phase 1a: Dose Escalation Part A-CN | Experimental | Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants Receives: Drug: BGB-24714 |
| Phase 1a: Dose Escalation Part E | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants Receives: Drug: BGB-24714; Drug: Paclitaxel; Drug: Carboplatin |
| Phase 1b: Dose Expansion | Experimental | BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors. Receives: Drug: BGB-24714; Drug: Paclitaxel; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.
Measured: approximately 6 months
Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Measured: approximately 6 months
Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
Measured: approximately 6 months
Dose Expansion: Objective response rate (ORR)
ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: approximately 2 Years
Secondary outcomes (18)
Dose Escalation: Objective response rate (ORR)
ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: approximately 2 Years
Dose Expansion: Progression-free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of disease progression as determined by the investigator using RECIST v1.1 or death, whichever occurs first
Measured: approximately 2 Years
Dose Expansion: Number of participants with adverse events
Number of participants with AEs and SAEs
Measured: approximately 2 Years
Duration of Response (DOR)
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: approximately 2 Years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: approximately 2 Years
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: approximately 2 Years
Plasma Concentrations of BGB-24714 and its metabolite
Measured: approximately 2 Years
Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Terminal Half-life (t1/2) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Apparent Clearance (CL/F) of BGB-24714
Measured: Up to 48 hours postdose
Apparent Volume Of Distribution (Vz/F) of BGB-24714
Measured: Up to 48 hours postdose
Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration at Steady State (AUClast,ss) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite
Measured: Up to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start6 Jul 2022
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Why it stopped: The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by BeiGeneThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381909
- Sponsor's protocol ID
- BGB-24714-101
- Other IDs
- CTR20232532
- Status last verified
- Feb 2026
- First submitted
- 16 May 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and With Combination Therapies in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT05381909
- Acronym / sponsor ID
- BGB-24714-101
- Conditions
- Solid Tumor, Adult
- Keywords
- Solid tumors, Advanced Solid Tumors, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.
- Enrolment
- 157 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 19 May 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.
This study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation Part A | Experimental | Drug: BGB-24714Participants will receive escalating doses of BGB-24714 as monotherapy |
| Phase 1a: Dose Escalation Part B | Experimental | Drug: BGB-24714, Drug: PaclitaxelParticipants will receive increasing dose levels of BGB-24714 in combination with paclitaxel |
| Phase 1a: Dose Escalation Part C | Experimental | Drug: BGB-24714, Drug: Paclitaxel, Drug: CarboplatinParticipants will receive increasing dose levels of BGB-24714 in combination with chemoradiation |
| Phase 1a: Dose Escalation Part D | Experimental | Drug: BGB-24714, Drug: Paclitaxel, Drug: CarboplatinParticipants will receive increasing dose levels of BGB-24714 in combination with chemoradiation |
| Phase 1a: Dose Escalation Part A-CN | Experimental | Drug: BGB-24714Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants |
| Phase 1a: Dose Escalation Part E | Experimental | Drug: BGB-24714, Drug: Paclitaxel, Drug: CarboplatinParticipants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants |
| Phase 1b: Dose Expansion | Experimental | Drug: BGB-24714, Drug: Paclitaxel, Drug: DocetaxelBGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
- Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).
- Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.
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 |
|---|---|---|
| BGB-24714administered orally | Drug | Phase 1a: Dose Escalation Part A, Phase 1a: Dose Escalation Part A-CN, Phase 1a: Dose Escalation Part B, Phase 1a: Dose Escalation Part C, Phase 1a: Dose Escalation Part D, Phase 1a: Dose Escalation Part E, Phase 1b: Dose Expansion |
| Paclitaxeladministered intravenously | Drug | Phase 1a: Dose Escalation Part B, Phase 1a: Dose Escalation Part C, Phase 1a: Dose Escalation Part D, Phase 1a: Dose Escalation Part E, Phase 1b: Dose Expansion |
| Carboplatinadministered intravenously | Drug | Phase 1a: Dose Escalation Part C, Phase 1a: Dose Escalation Part D, Phase 1a: Dose Escalation Part E |
| Docetaxeladministered intravenously | Drug | Phase 1b: Dose Expansion |
Primary outcome
Dose Escalation: Number of participants with adverse events (AEs)
Time frame: approximately 6 months
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.
Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Time frame: approximately 6 months
Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Time frame: approximately 6 months
Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
Dose Expansion: Objective response rate (ORR)
Time frame: approximately 2 Years
ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
18 secondary outcomes
Dose Escalation: Objective response rate (ORR)
Time frame: approximately 2 Years
Dose Expansion: Progression-free Survival (PFS)
Time frame: approximately 2 Years
Dose Expansion: Number of participants with adverse events
Time frame: approximately 2 Years
Duration of Response (DOR)
Time frame: approximately 2 Years
Disease Control Rate (DCR)
Time frame: approximately 2 Years
Clinical Benefit Rate (CBR)
Time frame: approximately 2 Years
Plasma Concentrations of BGB-24714 and its metabolite
Time frame: approximately 2 Years
Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Terminal Half-life (t1/2) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Apparent Clearance (CL/F) of BGB-24714
Time frame: Up to 48 hours postdose
Apparent Volume Of Distribution (Vz/F) of BGB-24714
Time frame: Up to 48 hours postdose
Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration at Steady State (AUClast,ss) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite
Time frame: Up to 48 hours postdose
Results and safety
The study was stopped early (reason given: The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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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.
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-24714, Paclitaxel and Carboplatin in people with Solid Tumor, Adult, run by BeiGene at 34 sites in 5 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 0 inclusion and 6 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Australia, China, South Korea, New Zealand. 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: The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.). 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?
Dose Escalation: Number of participants with adverse events (AEs) (time frame: approximately 6 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?
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 Feb 2026.