ClinicalTrials.gg
Sign In
Not yet recruitingNCT07893535Updated Oct 26, 2026

An Investigational Study of BON-106 in Adults With Advanced or Metastatic Solid Tumors

A Phase 1 interventional study of BON-106 in Solid Tumor, Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by BeOne Medicines. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
96
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BON-106 in adults with advanced or metastatic solid tumors.

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).

BON-106 is an experimental immunotherapy that is designed to activate immune cells that can recognize and attack tumor cells.

The purpose of this study is to test the safety and tolerability of BON-106 and identify the recommended dose and dosing schedule that can be taken without having serious side effects in adults with advanced or metastatic solid tumors. It will also test to see how well BON-106 works in adults with selected types of solid tumors.

This study consists of 2 phases, one called dose escalation and one called dose expansion. During the dose escalation phase, the study doctors will test different doses of BON-106 to find the recommended dose that people can take without having serious side effects. During the dose expansion phase, the study doctors will test BON-106 in a larger number of people with specific tumor types using the dose(s) identified from the dose escalation phase of the study.

The study will enroll adults at multiple centers worldwide with advanced or metastatic solid tumors. The overall time to participate in this study is about 28 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.

02

Conditions studied

  • Solid Tumor
  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Browse trials for

Keywords

  • BON-106
  • Immunotherapy
03

In context

Neoplasm Metastasis

3,564 studies on the registry are indexed under Neoplasm Metastasis; 875 are open to participants now.

This study's planned enrollment of 96 is above the median of 54 across 2,800 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

BeOne Medicines is the lead sponsor of 65 studies on the registry; 45 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse BeOne Medicines studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Patients must be ≥ 18 years of age and must sign the ICF and be capable of giving written informed consent
  • Patients must have either experienced disease recurrence or progression following standard systemic therapy, been intolerant of or ineligible for standard therapy, have no standard treatment available or no satisfactory alternative treatment as determined by the investigator.
  • Tumors harboring actionable genomic alterations, patients must have experienced disease recurrence or progression following ≥ 1 approved targeted therapy for advanced or metastatic disease, where applicable.
  • For Phase 1b, patients with advanced or metastatic disease in select solid tumors must have received ≥ 1 but no more than 2 or 3 prior lines of systemic therapy for advanced or metastatic disease.
  • Patients must provide agreement for collection of tumor tissue samples.
  • Must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate organ function
  • Must be willing to use effective birth control for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • History of severe allergic reactions or hypersensitivity to other monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), or trispecific antibodies (TsAbs), or the active ingredients and excipients of BON-106.
  • Active leptomeningeal disease, primary brain tumors, or uncontrolled, untreated brain metastasis.
  • Active autoimmune diseases that may relapse.
  • Patients with immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents, prior allogeneic stem cell transplantation, or organ transplantation.
  • Patients with infection (including tuberculosis infection, or other) requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Phase 1a Dose Escalation

    Sequential cohorts of increasing dose levels of BON-106 will be evaluated.

    Drug: BON-106

  • Experimental
    Phase 1b Dose Expansion

    Participants with selected advanced solid tumors will receive BON-106 at the selected dose(s).

    Drug: BON-106

Interventions

  • DrugBON-106

    Administered by intravenous infusion

06

What researchers measure

Primary outcomes

  1. Dose Escalation Phase: Number of Participants with Dose-limiting Toxicities (DLTs)

    Time frame: Up to approximately 1 month

  2. Dose Escalation Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)

    Time frame: From first dose of study drug until 30 days after last dose, up to approximately 24 months.

  3. Dose Expansion Phase: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) with confirmation per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Dose Escalation Phase: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) with confirmation per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

    Time frame: Up to approximately 24 months

  2. 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: Up to approximately 24 months

  3. Disease Control Rate (DCR) at Week 12 and Week 24

    DCR at 12 weeks and 24 weeks is defined as the percentage of participants who have CR, PR, or stable disease (SD) according to RECIST v1.1, and are alive and progression-free at the Week 12 and Week 24 assessment, respectively.

    Time frame: Week 12 and Week 24

  4. Dose-Expansion Phase: Progression-free Survival (PFS)

    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.

    Time frame: Up to approximately 24 months

  5. Serum Concentration of BON-106

    Time frame: Up to approximately 24 months

  6. Maximum Observed Concentration of BON-106

    Time frame: Approximately 2 months

  7. Area Under the Concentration-time Curve (AUC) of BON-106

    Time frame: Approximately 2 months

  8. Elimination Half-life (t1/2) of BON-106

    Time frame: Approximately 2 months

  9. Dose- Expansion Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From first dose of study drug until 30 days after last dose, up to approximately 24 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.

Of 207 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 75. This study's planned 48 months is close to that.

Counting every sponsor, half of 372 studies reached it within 53 months; a quarter within 33 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07893535
Lead sponsor
BeOne Medicines
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 26, 2026

Study contacts

Study Director
Contact
clinicaltrials@beonemed.com
1-877-828-5568
Study Director
study director · BeOne Medicines

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasm Metastasis →

Other studies from this sponsor

BeOne Medicines →

Start the discussion