Advanced Solid TumorPhase 1NCT07896460
A First-in-Human Study of BG-92505 Alone or in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
A Phase 1 study testing BG-92505 and Anti-Cancer Agent in people with Advanced Solid Tumor, run by BeOne Medicines.
Trial summary
The purpose of this study is to test if the BG-92505 is safe and if it works in patients with advanced solid tumors when it is given on its own or in combination with anti-cancer agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BG-92505 and Anti-Cancer Agent
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 29 Aug 2028
- 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
- Participants are eligible to be included in the study only if they meet all the following criteria:
- (i) Part A1 (Mono Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), or hepatocellular carcinoma (HCC) who have documented disease progression on prior available standard systemic therapy or for whom treatment is not available or not tolerated or determined not appropriate based on investigator's judgment.
- Part A2 (Mono Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable squamous NSCLC, ESCC, or HNSCC who have documented disease progression on prior available standard systemic therapy or for whom treatment is not available or not tolerated or determined not appropriate based on investigator's judgment.
- Part B (Combo Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable squamous NSCLC, ESCC, or HNSCC whose disease has progressed on prior standard systemic therapy.
- Must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Who cannot join
- Participants are excluded from the study if they meet any of the following criteria:
- Prior treatment with any KEAP1 activator and the ant-cancer agent (only for Part B).
- Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredients and excipients of study drug.
- Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
- Participants who are known to have a mutation that has no expectation of benefit from BG-92505.
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-92505 Alone and in Combination With Other Antineoplastic Agents in Patients With Advanced Solid Tumors
The purpose of this study is to test if the BG-92505 is safe and if it works in patients with advanced solid tumors when it is given on its own or in combination with anti-cancer agents.
Read the detailed description
A solid tumor is an abnormal lump or mass of tissue that forms when cells grow out of control. Solid tumors can develop in organs, bones, or soft tissues. An advanced or metastatic solid tumor is a cancer that has either grown into nearby tissues (" advanced") or spread to distant parts of the body (" metastatic").
The purpose of this study is to test whether BG-92505 is safe as monotherapy or in combination with other anti-cancer agents and if it can help to treat adults with advanced or metastatic solid tumors.
BG-92505 is a pill taken by mouth. It helps turn on a protein called Kelch-like ECH-associated protein 1 (KEAP1). KEAP1 helps break down another protein called nuclear factor erythroid 2-related factor 2 (NRF2). When NRF2 stays too active, it can help cancer cells survive, grow, and resist treatment. By working on the KEAP1-NRF2 pathway, BG-92505 may help slow or stop cancer cell growth.
This study will have a dose escalation and safety expansion part. During the dose escalation part, the study doctors will test different doses of BG-92505 either alone or in combination with other anti-cancer agents to find the recommended dose that people can take without having serious side effects.
During the safety expansion part, the study doctors will test the study drug in a larger number of people using 2-3 doses identified from the dose escalation part.
The study will enroll participants at multiple centers worldwide who have been diagnosed with an advanced solid tumor. The overall time to participate in this study is approximately 24 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests and imaging.
- Conditions
- Advanced Solid Tumor
- Being tested
- BG-92505, Anti-Cancer Agent
- Keywords
- Antineoplastic agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-92505Drug
Administered orally.
Anti-Cancer AgentDrug
Administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part A1: Monotherapy dose escalation | Experimental | Ascending dose levels of BG-92505 will be evaluated as monotherapy in participants with selected advanced solid tumors. Receives: Drug: BG-92505 |
| Part A2: Monotherapy safety expansion | Experimental | Selected dose levels of BG-92505 that have been determined to be safe in Monotherapy Dose Escalation, will be evaluated in participants with selected advanced solid tumors. Receives: Drug: BG-92505 |
| Part B: Combination Dose Escalation (BG-92505 + Anti-cancer agent) | Experimental | Ascending dose levels of BG-92505 in combination with anti-cancer agent will be evaluated in participants with selected advanced solid tumors. Receives: Drug: BG-92505; Drug: Anti-Cancer Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured: Approximately 1 month
Number of Participants with Treatment-emergent Adverse Events, Treatment-related Adverse Events, and Serious Adverse Events
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment, whether considered related to study treatment or not.
A serious adverse event is any untoward medical occurrence that, at any dose, meets one or more of the criteria listed in the view of either the investigator or the Sponsor:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
Measured: Approximately 24 months
Secondary outcomes (5)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) 1.1 assessed by the investigator.
Measured: Approximately 24 months
Duration of response (DOR)
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: Approximately 24 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease, as assessed by the investigator.
Measured: Approximately 24 months
Progression-free Survival (PFS)
PFS is defined as the time from the date of the first administration of study treatment to the date of the first documentation of disease progression assessed by the investigator according to RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: Approximately 24 months
Plasma concentrations of BG-92505
Measured: Predose and postdose, up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion29 Aug 2028 (estimated)
- Study completion29 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896460
- Sponsor's protocol ID
- BG-92505-101
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-92505 Alone and in Combination With Other Antineoplastic Agents in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07896460
- Acronym / sponsor ID
- BG-92505-101
- Conditions
- Advanced Solid Tumor
- Keywords
- Antineoplastic agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 29 Aug 2028 (estimated)
- Study completion
- 29 Aug 2028 (estimated)
- First posted
- 27 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.
The purpose of this study is to test if the BG-92505 is safe and if it works in patients with advanced solid tumors when it is given on its own or in combination with anti-cancer agents.
Detailed description
A solid tumor is an abnormal lump or mass of tissue that forms when cells grow out of control. Solid tumors can develop in organs, bones, or soft tissues. An advanced or metastatic solid tumor is a cancer that has either grown into nearby tissues (" advanced") or spread to distant parts of the body (" metastatic").
The purpose of this study is to test whether BG-92505 is safe as monotherapy or in combination with other anti-cancer agents and if it can help to treat adults with advanced or metastatic solid tumors.
BG-92505 is a pill taken by mouth. It helps turn on a protein called Kelch-like ECH-associated protein 1 (KEAP1). KEAP1 helps break down another protein called nuclear factor erythroid 2-related factor 2 (NRF2). When NRF2 stays too active, it can help cancer cells survive, grow, and resist treatment. By working on the KEAP1-NRF2 pathway, BG-92505 may help slow or stop cancer cell growth.
This study will have a dose escalation and safety expansion part. During the dose escalation part, the study doctors will test different doses of BG-92505 either alone or in combination with other anti-cancer agents to find the recommended dose that people can take without having serious side effects.
During the safety expansion part, the study doctors will test the study drug in a larger number of people using 2-3 doses identified from the dose escalation part.
The study will enroll participants at multiple centers worldwide who have been diagnosed with an advanced solid tumor. The overall time to participate in this study is approximately 24 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests and imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A1: Monotherapy dose escalation | Experimental | Drug: BG-92505Ascending dose levels of BG-92505 will be evaluated as monotherapy in participants with selected advanced solid tumors. |
| Part A2: Monotherapy safety expansion | Experimental | Drug: BG-92505Selected dose levels of BG-92505 that have been determined to be safe in Monotherapy Dose Escalation, will be evaluated in participants with selected advanced solid tumors. |
| Part B: Combination Dose Escalation (BG-92505 + Anti-cancer agent) | Experimental | Drug: BG-92505, Drug: Anti-Cancer AgentAscending dose levels of BG-92505 in combination with anti-cancer agent will be evaluated in participants with selected advanced solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants are eligible to be included in the study only if they meet all the following criteria:
- (i) Part A1 (Mono Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), or hepatocellular carcinoma (HCC) who have documented disease progression on prior available standard systemic therapy or for whom treatment is not available or not tolerated or determined not appropriate based on investigator's judgment.
- Must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (6 listed)
- Prior treatment with any KEAP1 activator and the ant-cancer agent (only for Part B).
- Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredients and excipients of study drug.
- Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
- Participants who are known to have a mutation that has no expectation of benefit from BG-92505.
- Note: Other protocol defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| BG-92505Administered orally. | Drug | Part A1: Monotherapy dose escalation, Part A2: Monotherapy safety expansion, Part B: Combination Dose Escalation (BG-92505 + Anti-cancer agent) |
| Anti-Cancer AgentAdministered by intravenous infusion. | Drug | Part B: Combination Dose Escalation (BG-92505 + Anti-cancer agent) |
Primary outcome
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Approximately 1 month
Number of Participants with Treatment-emergent Adverse Events, Treatment-related Adverse Events, and Serious Adverse Events
Time frame: Approximately 24 months
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment, whether considered related to study treatment or not. A serious adverse event is any untoward medical occurrence that, at any dose, meets one or more of the criteria listed in the view of either the investigator or the Sponsor: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Is a congenital anomaly/birth defect
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 24 months
Duration of response (DOR)
Time frame: Approximately 24 months
Disease Control Rate (DCR)
Time frame: Approximately 24 months
Progression-free Survival (PFS)
Time frame: Approximately 24 months
Plasma concentrations of BG-92505
Time frame: Predose and postdose, up to approximately 6 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 27 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.
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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.
Study Director study director
BeOne Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG-92505 and Anti-Cancer Agent in people with Advanced Solid Tumor, 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 6 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: opening soon, as of the sponsor's last update on 27 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 (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?
Number of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Approximately 1 month). The study lists 2 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 27 Oct 2026.