Advanced Solid TumorPhase 1NCT06422520
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
A Phase 1 study testing BGB-C354 and Tislelizumab in people with Advanced Solid Tumor, run by BeOne Medicines at 14 sites in 3 countries.
Trial summary
This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. 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?
- BGB-C354 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 8 Jul 2024to 15 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
- Adequate organ function.
- Females 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(s).
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).
Who cannot join
- Prior treatment with B7H3-targeted therapy.
- For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
- Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
- Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
- Uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s).
- Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, 32827-7400
Next Oncology
San Antonio, Texas, 78229-6028
Washington University School of Medicine
St Louis, Missouri, 63110-1010
China5 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jilin Cancer Hospital
Changchun, Jilin, 130021
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Australia4 sites
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065
The Alfred Hospital
Melbourne, Victoria, VIC 3004
One Clinical Research
Nedlands, Western Australia, WA 6009
Westmead Hospital
Westmead, New South Wales, NSW 2145
About this study
Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors.
Study details include:
- The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
- The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years.
- The study duration is estimated to be approximately 5 years.
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
- Advanced Solid Tumor
- Being tested
- BGB-C354, Tislelizumab
- Keywords
- BGB-C354, Tislelizumab, First-in-human, Advanced solid tumor, Anti-PD-1 Monoclonal Antibody, B7H3, antibody drug conjugate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-C354Drug
Administered by intravenous infusion
TislelizumabDrug
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Part A (Monotherapy Dose Escalation) | Experimental | BGB-C354 monotherapy doses at sequentially increasing levels. Receives: Drug: BGB-C354 |
| Phase 1a: Part B (Safety Expansion) | Experimental | Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation. Receives: Drug: BGB-C354 |
| Phase 1b: Part C (Monotherapy Expansion) | Experimental | BGB-C354 will be administered at the recommended dose for expansion (RDFE). Receives: Drug: BGB-C354 |
| Phase 1b: Part D (Combination Therapy Expansion) | Experimental | BGB-C354 and tislelizumab will be adminsitered at doses determined by the SMC. Receives: Drug: BGB-C354; Drug: Tislelizumab |
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)
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Measured: Approximately 24 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively
Measured: Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any 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 (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Measured: Approximately 24 months
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab
The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Measured: Approximately 24 months
Secondary outcomes (15)
Phase 1a: ORR
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Measured: Approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Measured: Approximately 24 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.
Measured: Approximately 24 months
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first as determined from tumor assessments by the investigator using RECIST v1.1.
Measured: Approximately 24 months
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria
Measured: Approximately 24 months
Maximum observed plasma concentration (Cmax) for BGB-C354
Measured: Twice in the first 3 months
Minimum observed plasma concentration (Cmin) for BGB-C354
Measured: Approximately 12 months
Time to maximum plasma concentration (Tmax) for BGB-C354
Measured: Twice in the first 3 months
Half-life (t1/2) for BGB-C354
Measured: Twice in the first 3 months
Area under the concentration-time curve (AUC) for BGB-C354
Measured: Twice in the first 3 months
Apparent clearance (CL/F) for BGB-C354
Measured: Approximately 12 months
Apparent volume of distribution (Vz/F) for BGB-C354
Measured: Approximately 12 months
Accumulation ratio for BGB-C354
Measured: Approximately 12 months
Number of participants with anti-drug antibodies (ADAs) to BGB-C354
Measured: Approximately 12 months
Serum concentration of BGB-C354
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start8 Jul 2024
- Primary completion15 May 2026
- Study completion15 May 2026
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
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
- NCT06422520
- Sponsor's protocol ID
- BGB-C354-101
- Other IDs
- 2024-513280-11-00
- Status last verified
- Jun 2026
- First submitted
- 15 May 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06422520
- Acronym / sponsor ID
- BGB-C354-101
- Conditions
- Advanced Solid Tumor
- Keywords
- BGB-C354, Tislelizumab, First-in-human, Advanced solid tumor, Anti-PD-1 Monoclonal Antibody, B7H3, antibody drug conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 21 May 2024 (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 is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors.
Study details include:
- The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
- The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years.
- The study duration is estimated to be approximately 5 years.
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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Part A (Monotherapy Dose Escalation) | Experimental | Drug: BGB-C354BGB-C354 monotherapy doses at sequentially increasing levels. |
| Phase 1a: Part B (Safety Expansion) | Experimental | Drug: BGB-C354Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation. |
| Phase 1b: Part C (Monotherapy Expansion) | Experimental | Drug: BGB-C354BGB-C354 will be administered at the recommended dose for expansion (RDFE). |
| Phase 1b: Part D (Combination Therapy Expansion) | Experimental | Drug: BGB-C354, Drug: TislelizumabBGB-C354 and tislelizumab will be adminsitered at doses determined by the SMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
Key exclusion criteria (8 listed)
- Prior treatment with B7H3-targeted therapy.
- For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
- Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
- Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
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 |
|---|---|---|
| BGB-C354Administered by intravenous infusion | Drug | Phase 1a: Part A (Monotherapy Dose Escalation), Phase 1a: Part B (Safety Expansion), Phase 1b: Part C (Monotherapy Expansion), Phase 1b: Part D (Combination Therapy Expansion) |
| TislelizumabAdministered by intravenous infusion | Drug | Phase 1b: Part D (Combination Therapy Expansion) |
Primary outcome
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 24 months
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354
Time frame: Approximately 1 month
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
Time frame: Approximately 24 months
The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any 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 (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab
Time frame: Approximately 24 months
The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
15 secondary outcomes
Phase 1a: ORR
Time frame: Approximately 24 months
Duration of Response (DOR)
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
Maximum observed plasma concentration (Cmax) for BGB-C354
Time frame: Twice in the first 3 months
Minimum observed plasma concentration (Cmin) for BGB-C354
Time frame: Approximately 12 months
Time to maximum plasma concentration (Tmax) for BGB-C354
Time frame: Twice in the first 3 months
Half-life (t1/2) for BGB-C354
Time frame: Twice in the first 3 months
Area under the concentration-time curve (AUC) for BGB-C354
Time frame: Twice in the first 3 months
Apparent clearance (CL/F) for BGB-C354
Time frame: Approximately 12 months
Apparent volume of distribution (Vz/F) for BGB-C354
Time frame: Approximately 12 months
Accumulation ratio for BGB-C354
Time frame: Approximately 12 months
Number of participants with anti-drug antibodies (ADAs) to BGB-C354
Time frame: Approximately 12 months
Serum concentration of BGB-C354
Time frame: Approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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. This study is not recruiting at the moment.
Study Director study director
BeOne Medicines
14 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 BGB-C354 and Tislelizumab in people with Advanced Solid Tumor, run by BeOne Medicines at 14 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, China, Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 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 8 Jun 2026.