Solid TumorsPhase 1NCT07181681
A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
A Phase 1 study testing BG-C0902 in people with Solid Tumors and Advanced Solid Tumor, run by BeOne Medicines at 15 sites in 3 countries.
Trial summary
This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Advanced Solid Tumor
- What is being tested?
- BG-C0902
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 10 Nov 2025to 1 Nov 2027
- 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 with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated.
- Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug.
- Adequate bone marrow and organ function as indicated by the following laboratory values ≤ 14 days before the first dose of study drug
- Female participants of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 7 months after the last dose of study drug. They must also have a negative serum pregnancy test result ≤ 3 days before the first dose of study drug.
- Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of study drug.
Who cannot join
- History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins.
- For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:
- Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases
- Have measurable disease and/or evaluable disease outside CNS
- No ongoing requirement for corticosteroids as therapy for CNS disease; off corticosteroids ≥ 14 days before dosing with study drug; anticonvulsants at a stable dose are allowed
Show all 10Show fewer
- No stereotactic radiation or whole-brain radiation ≤ 14 days before the first dose of study drug
- History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
- Participants with active or chronic corneal disorder, including but not limited to Sjögren's, Fuch's corneal dystrophy, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 3 countries
China8 sites, 8 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
Shanghai, Shanghai Municipality, 201801
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Australia4 sites, 4 recruiting
- Recruiting
Cancer Research South Australia
Adelaide, South Australia, SA 5000
- Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
- Recruiting
Monash Health
Clayton, Victoria, VIC 3168
- Recruiting
The Alfred Hospital
Melbourne, Victoria, VIC 3004
United States3 sites, 3 recruiting
- Recruiting
Next Oncology Virginia
Fairfax, Virginia, 22031
- Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
- Recruiting
Next Oncology
San Antonio, Texas, 78229-6028
About this study
Official title: A Phase 1a/b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, an Antibody-Drug Conjugate Targeting Epidermal Growth Factor Receptor (EGFR) × Mesenchymal-Epithelial Transition (MET), Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).
Read the detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
- Conditions
- Solid Tumors, Advanced Solid Tumor
- Being tested
- BG-C0902
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-C0902Drug
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion of BG-C0902 | Experimental | Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy. Receives: Drug: BG-C0902 |
| Phase 1b: Dose Expansion of BG-C0902 | Experimental | The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors. Receives: Drug: BG-C0902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Approximately 24 Months
Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: Approximately 21 Days
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Measured: Approximately 24 Months
Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902
RDFE of BG-C0902 will be determined based upon the MTD or MAD.
Measured: Approximately 24 Months
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy
RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Measured: Approximately 24 Months
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Approximately 24 Months
Secondary outcomes (11)
Phase 1a: ORR
ORR is defined as the percentage of participants with best overall response of CR or PR. as assessed by the investigator using RECIST v1.1.
Measured: Approximately 24 Months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first confirmed objective response by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.
Measured: Approximately 24 Months
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response, of a CR, PR, and stable disease assessed by the investigator using RECIST v1.1.
Measured: Approximately 24 Months
Phase 1b: Progression-free Survival (PFS)
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Measured: Approximately 24 Months
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent AEs and SAEs.
Measured: Approximately 24 Months
Phase 1a and 1b: Area under the Concentration-time Curve (AUC) of BG-C0902, Total Antibody, and Payload
Measured: Two times in the first three months
Phase 1a and 1b: Maximum Observed Plasma Concentration (Cmax) of BG-C0902, Total Antibody, and Payload
Measured: Two times in the first three months
Phase 1a and 1b: Time to Maximum Concentration (Tmax) of BG-C0902, Total Antibody, and Payload
Measured: Two times in the first three months
Phase 1a and 1b: Half-life (t1/2) of BG-C0902, Total Antibody, and Payload
Measured: Two times in the first three months
Phase 1a and 1b: Volume of Distribution (Vd) of BG-C0902, Total Antibody, and Payload
Measured: Two times in the first three months
Phase 1a and 1b: Number of Participants with Anti-drug Antibodies (ADAs) to BG-C0902
Measured: Approximately 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start10 Nov 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181681
- Sponsor's protocol ID
- BG-C0902-101
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, an Antibody-Drug Conjugate Targeting Epidermal Growth Factor Receptor (EGFR) × Mesenchymal-Epithelial Transition (MET), Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07181681
- Acronym / sponsor ID
- BG-C0902-101
- Conditions
- Solid Tumors, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Sep 2025 (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 is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion of BG-C0902 | Experimental | Drug: BG-C0902Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy. |
| Phase 1b: Dose Expansion of BG-C0902 | Experimental | Drug: BG-C0902The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated.
- Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug.
- Adequate bone marrow and organ function as indicated by the following laboratory values ≤ 14 days before the first dose of study drug
Key exclusion criteria (10 listed)
- History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins.
- For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:
- History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
- Participants with active or chronic corneal disorder, including but not limited to Sjögren's, Fuch's corneal dystrophy, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
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-C0902Administered by intravenous infusion | Drug | Phase 1a: Dose Escalation and Safety Expansion of BG-C0902, Phase 1b: Dose Expansion of BG-C0902 |
Primary outcome
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 24 Months
Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Approximately 21 Days
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902
Time frame: Approximately 24 Months
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902
Time frame: Approximately 24 Months
RDFE of BG-C0902 will be determined based upon the MTD or MAD.
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy
Time frame: Approximately 24 Months
RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Phase 1b: Overall Response Rate (ORR)
Time frame: Approximately 24 Months
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
11 secondary outcomes
Phase 1a: ORR
Time frame: Approximately 24 Months
Phase 1a and 1b: Duration of Response (DOR)
Time frame: Approximately 24 Months
Phase 1a and 1b: Disease Control Rate (DCR)
Time frame: Approximately 24 Months
Phase 1b: Progression-free Survival (PFS)
Time frame: Approximately 24 Months
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 24 Months
Phase 1a and 1b: Area under the Concentration-time Curve (AUC) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Maximum Observed Plasma Concentration (Cmax) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Time to Maximum Concentration (Tmax) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Half-life (t1/2) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Volume of Distribution (Vd) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Number of Participants with Anti-drug Antibodies (ADAs) to BG-C0902
Time frame: Approximately 24 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 28 Sep 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 Medicines
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG-C0902 in people with Solid Tumors and Advanced Solid Tumor, run by BeOne Medicines at 15 sites in 3 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China, Australia, United States. 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?
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 Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Approximately 24 Months). The study lists 6 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 28 Sep 2026.