A Phase 1 interventional study of BG-92505 and Anti-Cancer Agent in Advanced Solid Tumor, sponsored by BeOne Medicines. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment
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.
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.
BeOne Medicines is the lead sponsor of 68 studies on the registry; 48 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 or cytologically confirmed advanced, , 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.
(ii) 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.
(iii) 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.
Exclusion Criteria:
Participants are excluded from the study if they meet any of the following criteria:
Note: Other protocol defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ascending dose levels of BG-92505 will be evaluated as monotherapy in participants with selected advanced solid tumors.
Drug: BG-92505
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.
Drug: BG-92505
Ascending dose levels of BG-92505 in combination with anti-cancer agent will be evaluated in participants with selected advanced solid tumors.
Drug: BG-92505 · Drug: Anti-Cancer Agent
Administered orally.
Administered by intravenous infusion.
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
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
Time frame: Approximately 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 24 months
Plasma concentrations of BG-92505
Time frame: Predose and postdose, up to approximately 6 months
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2028, 20 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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