Solid TumorsPhase 1NCT07904845

A Study of BON-C1393 in Adults With Advanced Solid Tumors

A Phase 1 study testing BON-C1393, Bevacizumab and Capecitabine in people with Solid Tumors and Advanced Solid Tumors, run by BeOne Medicines.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BON-C1393 monotherapy or in combination with other anticancer regimens in adults with selected advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors, Advanced Solid Tumors
What is being tested?: BON-C1393, Bevacizumab and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: No sites listed yet
Study dates: 23 Nov 2026to 27 Feb 2029
Phase: Phase 1
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

Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic solid tumor intolerant, refractory to or progressing after standard systemic therapies.
Must be able to provide archival tumor tissue (formalin-fixed, paraffin-embedded tissue block (FFPE) block or approximately 10-15 freshly cut unstained FFPE slides)
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.0
Must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study drug(s):
Must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.

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Platelets ≥ 100 × 109/L.
Hemoglobin ≥ 90 g/L. b. Estimated glomerular filtration rate (GFR) ≥ 50 mL/min, as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) c. Serum total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) (total bilirubin must be ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN for patients with Gilbert's syndrome).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or < 5 × ULN if hepatic metastases are present.
Albumin ≥ 2.0 g/dL. f. In Phase 1b Part D, for patients receiving combination therapy with bevacizumab, additional inclusion criteria are listed below:
Urine dipstick for proteinuria < 2+ (within 7 days prior to initiation of study treatment). Patients discovered to have ³ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours.
Coagulation parameters: international normalized ratio (INR) of ≤ 1.5 (or an in-range INR of ≤ 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.2 × ULN.
Female of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 months after the last dose of BON-C1393, for ≥ 6 months after the last dose of bevacizumab or capecitabine, whichever comes later. They must also have a negative urine or serum pregnancy test result ≤ 3 days before first dose of study drug/treatment.
Nonsterile male must be willing to use condom and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of BON-C1393, for ≥ 3 months after the last dose of capecitabine, whichever comes later.

Who cannot join

Prior treatment with any B7-H3 or ITGB-6 -targeted ADCs or ADCs containing topoisomerase 1 inhibitor (TOP) inhibitor as payload.
History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics.
Unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
Active hepatitis C.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Any major surgical procedure ≤ 28 days (or ≤ 14 days for low-invasive cases [eg, colostomy]) before the first dose of study drug. Must have recovered adequately from the surgery and/or complications from the surgical procedures before the first dose of study drug/treatment.

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Any of following treatments before the first dose of study drug:
Prior systemic anticancer therapy (including targeted therapy and immunomodulators [eg, interleukin (IL), interferon, thymosin, etc]) ≤ 14 days, ≤ 28 days for immuno-oncological antibody, ≤14 days or 5 half-lives (whichever is shorter) for chemotherapy, ADCs, or investigational therapy.
Radiation therapy (curative) and palliative radiation therapy to the chest ≤ 4 weeks; ≤ 2 weeks for palliative radiation therapy to other areas (ie, limited field and 10 or fewer days or fractions) including whole-brain radiotherapy.
Chinese patent medicine with anticancer activity approved by the China NMPA (regardless of the type of cancer) ≤ 14 days (Appendix 4).
Herbal remedies with immune-stimulating properties (eg, mistletoe extract) or that are known to potentially interfere with liver or other major organ functions (eg, hypericin) ≤ 14 days or 5 half-lives, whichever is shorter or known.
Ongoing treatment with a strong CYP3A inhibitor, or strong CYP3A inducer, or strong CYP1A2 inhibitor, or strong CYP1A2 inducer

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

About this study

Official title: A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BON-C1393 in Patients With Selected Advanced Solid Tumors

Read the detailed description

Advanced solid tumors are malignant cancers that develop in organs of the body. They spread to other parts of the body and may reoccur after treatment, or no longer respond to available therapies or surgery. Many people with advanced solid tumors have limited treatment options, and their cancer may continue to grow or spread. Therefore, there is an ongoing need to develop novel therapies that may improve tumor control and prolong survival.

BON-C1393 is a targeted cancer medicine called an antibody-drug conjugate (ADC). An ADC consists of an antibody linked to a drug that can kill cancer cells. The antibody part of BON-C1393 attaches to proteins that are found on the surface of cancer cells. After it attaches to these proteins, BON-C1393 enters the cancer cell where the drug causes DNA damage and cell death.

The purpose of this study is to test whether BON-C1393 is safe and if it can help treat adults with selected advanced solid tumors.

This study consists of 2 parts, one called dose escalation and dose exploration (Phase 1a) and one called dose expansion (Phase 1b). During the dose escalation and dose exploration part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects.

During the dose expansion part, the study doctors will test the study drug in a larger number of people using the doses identified from Phase 1a. The study will enroll adults with advanced solid tumors at multiple centers in the Asia-Pacific region.

The overall time to participate in this study is approximately 9 months for Phase 1a and approximately 12 months for Phase 1b. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.

Conditions: Solid Tumors, Advanced Solid Tumors
Being tested: BON-C1393, Bevacizumab, Capecitabine
Keywords: First-in-Human

What participants receive

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

BON-C1393Drug
Administered intravenously
BevacizumabDrug
Administered intravenously
CapecitabineDrug
Administered orally

Study groups in NCT07904845
Study group	Role	What they receive
Phase 1a Part A: Monotherapy Dose Escalation	Experimental	Sequential cohorts of increasing dose levels of BON-C1393 will be evaluated. Receives: Drug: BON-C1393
Phase 1a Part B: Monotherapy Dose Exploration	Experimental	Participants with select advanced solid tumors will receive BON-C1393 at 2 - 3 selected dose levels that have been determined to be safe in Part A. Receives: Drug: BON-C1393
Phase 1b Part C: Monotherapy Dose Expansion	Experimental	Participants with select advanced solid tumors will receive BON-C1393 as monotherapy at the recommended doses for expansion (RDFEs) identified in Phase 1a. Receives: Drug: BON-C1393
Phase 1b Part D: Dose Expansion Combination Therapy	Experimental	Participants with select advanced solid tumors will receive BON-C1393 in combination with bevacizumab and capecitabine. Receives: Drug: BON-C1393; Drug: Bevacizumab; Drug: Capecitabine

What is being measured

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

Phase 1a: Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured: Approximately 1 month
Phase 1a: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)
Measured: Up to approximately 9 months
Phase 1b: Overall Response Rate (ORR) Assessed by the Investigator
ORR is defined as the percentage of participants with a best overall response of partial response or better per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 12 months

Secondary outcomes (13)

Phase 1a: Overall Response Rate (ORR) Assessed by the Investigator
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 9 months
Phase 1a: Duration of Response (DOR) Assessed by the Investigator
DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 9 months
Phase 1b: Duration of Response (DOR) Assessed by the Investigator
DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 12 months
Phase 1a: Disease Control Rate (DCR) Assessed by the Investigator
DCR is defined as the percentage of participants with a BOR of a CR, PR, or stable disease (SD) per RECIST v1.1.
Measured: Up to approximately 9 months
Phase 1b: Disease Control Rate (DCR) at 12 Weeks Assessed by the Investigator
DCR at 12 weeks is defined as the percentage of participants with CR, PR, or SD per RECIST v1.1, and are alive and progression-free at Week 12.
Measured: 12 Weeks
Phase 1b: Disease Control Rate (DCR) at 24 Weeks Assessed by the Investigator
DCR at 24 weeks is defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, and are alive and progression-free at the Week 24.
Measured: 24 weeks
Phase 1b: Progression-free Survival (PFS) Assessed by the Investigator
PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 12 months
Area Under the Concentration Time Curve (AUC) of BON-C1393
Measured: Up to approximately 3 months
Maximum Observed Plasma Concentration (Cmax) of BON-C1393
Measured: Up to approximately 8 months
Time to Maximum Plasma Concentration (Tmax) of BON-C1393
Measured: Up to approximately 8 months
Terminal Half-Life (t1/2) of BON-C1393
Measured: Up to approximately 3 months
Plasma Concentrations of BON-C1393
Measured: Up to approximately 12 months
Phase 1b: Number of Participants with Adverse Events
Measured: Up to approximately 12 months

Timeline

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

23 Nov 202627 Feb 2029

First posted29 Oct 2026
Study start23 Nov 2026 (estimated)
Primary completion27 Feb 2029 (estimated)
Study completion27 Feb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies of the same condition, open and under way.
More trials run by BeOne MedicinesThe 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07904845
Sponsor's protocol ID: BON-C1393-101
Status last verified: Oct 2026
First submitted: 23 Oct 2026
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: BeOne 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. BeOne 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 BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Interested in taking part?

Study Director

1.877.828.5568

clinicaltrials@beonemed.com

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 sites and contacts

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BON-C1393 in Patients With Selected Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07904845
Acronym / sponsor ID: BON-C1393-101
Conditions: Solid Tumors, Advanced Solid Tumors
Keywords: First-in-Human
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: BeOne MedicinesIndustry (pharma, biotech, devices)
Study start: 23 Nov 2026 (estimated)
Primary completion: 27 Feb 2029 (estimated)
Study completion: 27 Feb 2029 (estimated)
First posted: 29 Oct 2026 (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.

Detailed description

The purpose of this study is to test whether BON-C1393 is safe and if it can help treat adults with selected advanced solid tumors.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1a Part A: Monotherapy Dose Escalation	Experimental	Drug: BON-C1393Sequential cohorts of increasing dose levels of BON-C1393 will be evaluated.
Phase 1a Part B: Monotherapy Dose Exploration	Experimental	Drug: BON-C1393Participants with select advanced solid tumors will receive BON-C1393 at 2 - 3 selected dose levels that have been determined to be safe in Part A.
Phase 1b Part C: Monotherapy Dose Expansion	Experimental	Drug: BON-C1393Participants with select advanced solid tumors will receive BON-C1393 as monotherapy at the recommended doses for expansion (RDFEs) identified in Phase 1a.
Phase 1b Part D: Dose Expansion Combination Therapy	Experimental	Drug: BON-C1393, Drug: Bevacizumab, Drug: CapecitabineParticipants with select advanced solid tumors will receive BON-C1393 in combination with bevacizumab and capecitabine.

Who may qualify

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

Key inclusion criteria (14 listed)

Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic solid tumor intolerant, refractory to or progressing after standard systemic therapies.
Must be able to provide archival tumor tissue (formalin-fixed, paraffin-embedded tissue block (FFPE) block or approximately 10-15 freshly cut unstained FFPE slides)
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.0
Must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study drug(s):
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.

Key exclusion criteria (12 listed)

Prior treatment with any B7-H3 or ITGB-6 -targeted ADCs or ADCs containing topoisomerase 1 inhibitor (TOP) inhibitor as payload.
History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics.
Unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
Active hepatitis C.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

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
BON-C1393Administered intravenously	Drug	Phase 1a Part A: Monotherapy Dose Escalation, Phase 1a Part B: Monotherapy Dose Exploration, Phase 1b Part C: Monotherapy Dose Expansion, Phase 1b Part D: Dose Expansion Combination Therapy
BevacizumabAdministered intravenously	Drug	Phase 1b Part D: Dose Expansion Combination Therapy
CapecitabineAdministered orally	Drug	Phase 1b Part D: Dose Expansion Combination Therapy

Primary outcome

Phase 1a: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Approximately 1 month
Phase 1a: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)
Time frame: Up to approximately 9 months
Phase 1b: Overall Response Rate (ORR) Assessed by the Investigator
Time frame: Up to approximately 12 months
ORR is defined as the percentage of participants with a best overall response of partial response or better per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

13 secondary outcomes

Phase 1a: Overall Response Rate (ORR) Assessed by the Investigator
Time frame: Up to approximately 9 months
Phase 1a: Duration of Response (DOR) Assessed by the Investigator
Time frame: Up to approximately 9 months
Phase 1b: Duration of Response (DOR) Assessed by the Investigator
Time frame: Up to approximately 12 months
Phase 1a: Disease Control Rate (DCR) Assessed by the Investigator
Time frame: Up to approximately 9 months
Phase 1b: Disease Control Rate (DCR) at 12 Weeks Assessed by the Investigator
Time frame: 12 Weeks
Phase 1b: Disease Control Rate (DCR) at 24 Weeks Assessed by the Investigator
Time frame: 24 weeks
Phase 1b: Progression-free Survival (PFS) Assessed by the Investigator
Time frame: Up to approximately 12 months
Area Under the Concentration Time Curve (AUC) of BON-C1393
Time frame: Up to approximately 3 months
Maximum Observed Plasma Concentration (Cmax) of BON-C1393
Time frame: Up to approximately 8 months
Time to Maximum Plasma Concentration (Tmax) of BON-C1393
Time frame: Up to approximately 8 months
Terminal Half-Life (t1/2) of BON-C1393
Time frame: Up to approximately 3 months
Plasma Concentrations of BON-C1393
Time frame: Up to approximately 12 months
Phase 1b: Number of Participants with Adverse Events
Time frame: Up to approximately 12 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 29 Oct 2026.
Individual participant dataSharing planned: Yes. BeOne 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. BeOne 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 BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Related trials for Solid Tumors

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

Study Director study director

BeOne Medicines

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BON-C1393, Bevacizumab and Capecitabine in people with Solid Tumors and Advanced Solid Tumors, run by BeOne Medicines.

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 14 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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 Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Approximately 1 month). 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?

On the ClinicalTrials.gov record for NCT07904845.

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 29 Oct 2026.