Advanced Solid TumorPhase 1NCT05935098
BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors
A Phase 1 study testing BGB-A3055, Tislelizumab and Chemotherapy in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by BeiGene at 26 sites in 5 countries.
Trial summary
This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Solid Tumor
- What is being tested?
- BGB-A3055, Tislelizumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 21 Aug 2023to 27 Jan 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
- Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).
- All participants are also required to demonstrate an ECOG Performance Status score of ≤1 within 3 days before the first dose of study drug(s) and have adequate organ function.
- Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting CCR8.
- >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants should be able to provide archival tumor tissue samples (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints.
- Females of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or up to 9 months after the last dose of chemotherapy, whichever is later. Females of childbearing potential must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study drug(s).
Who cannot join
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study drug(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).
- Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection.
- Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA < 500 IU/mL or < 2500 copies/mL) and considered stable are eligible. Participants with a negative HCV antibody test result at screening or a positive HCV antibody test result followed by a negative HCV RNA test result at screening are eligible to participate. Participants with treated HIV infection may be included if certain criteria are met.
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
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- Grade 3 immune-mediated adverse events on prior immune-oncology agent.
- Cardiovascular risk factors, including but not limited to pulmonary embolism ≤ 28 days or history of acute myocardial infarction or heart failure ≤ 6 months before the first dose of study drug(s).
- Uncontrolled diabetes.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
China9 sites
Changzhi Peoples Hospital
Changzhi, Shanxi, 046099
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
Shanghai, Shanghai Municipality, 201801
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Henan Cancer Hospital
Zhengzhou, Henan, 450000
United States6 sites
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
Next Dallas
Irving, Texas, 75039-2743
Advent Health Cancer Institute
Orlando, Florida, 32804-4603
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433
South Korea5 sites
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, 13620
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
Australia3 sites
Chris Obrien Lifehouse
Camperdown, New South Wales, 2050
Linear Clinical Research
Nedlands, Western Australia, 6009
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101
France3 sites
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000
Institut Curie
Paris, 75005
Ico Site Rene Gauducheau
SaintHerblain, 44805
About this study
Official title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors.
Key details of the study include:
- The study is expected to last about 36 months.
- Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Solid Tumor
- Being tested
- BGB-A3055, Tislelizumab, Chemotherapy
- Keywords
- BGB-A3055, Tislelizumab, Advanced solid tumors, Safety monitoring, Monoclonal antibody, Preliminary antitumor activity, Metastatic cancer, Metastatic Solid Tumor, PD1, CCR8
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-A3055Drug
Administered intravenously
TislelizumabDrug
Also called BGB-A317
Administered intravenously
ChemotherapyDrug
Administered in accordance with relevant local guidelines and/or prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy) | Experimental | Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels. Receives: Drug: BGB-A3055 |
| Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab) | Experimental | Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels. Receives: Drug: BGB-A3055; Drug: Tislelizumab |
| Phase 1b (Dose Expansion): | Experimental | Participants will receive the recommended dose for expansion (RDFE) of BGB-A3055 in combination with tislelizumab with or without chemotherapy to provide additional information on the safety, tolerability, and potential benefits of the recommended dose. Receives: Drug: BGB-A3055; Drug: Tislelizumab; Drug: Chemotherapy |
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)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the American Society for Transplantation and Cellular Therapy [ASTCT] consensus grading system for cytokine release syndrome [CRS]), and including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Measured: Up to 2 Years
Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered.
Measured: Up to 2 Years
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab
The RDFEs of BGB-A3055, alone or in combination with tislelizumab will be determined based on biological effectiveness taking preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration.
Measured: Up to 2 Years
Phase 1b (Dose Expansion): Objective Response Rate (ORR)
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to 2 Years
Secondary outcomes (11)
Phase 1a: ORR
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to 2 Years
Time to Response (TTR)
Defined as the time from the date of the first administration of study drug(s) to the first determination of an objective response.as determined from tumor assessments by the investigators per RECIST v1.1.
Measured: Up to 2 Years
Duration of Response (DOR)
Defined as the time from the first determination of an objective response to the time of first documentation of radiographic progression, as determined from tumor assessments by the investigators per RECIST v1.1, or death from any cause, whichever comes first.
Measured: Up to 2 Years
Disease Control Rate (DCR)
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease as determined from tumor assessments by the investigators per RECIST v1.1.
Measured: Up to 2 Years
Clinical Benefit Rate (CBR)
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) as determined from tumor assessments by the investigators per RECIST v1.1.
Measured: Up to 2 Years
Number of participants with anti-drug antibodies (ADAs) against BGB-A3055
Measured: Up to 2 Years
Serum concentration of BGB-A3055 at specified time points
Measured: Up to 2 Years
Phase 1b: Progression-Free Survival (PFS)
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as determined from tumor assessments by investigators per RECIST v1.1.
Measured: Up to 2 Years
Phase 1b: Number of participants with adverse events (AEs)
Number of participants with TEAEs and SAEs graded according to the NCI-CTCAE version 5.0 and the ASTCT consensus grading system for CRS, and including findings from laboratory assessments, ECGs, and physical examinations.
Measured: Up to 2 Years
Phase 1b: Association of CCR8 expression with clinical efficacy
Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.
Measured: Up to 2 Years
Phase 1b: Association of PD-L1 expression with clinical efficacy
Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start21 Aug 2023
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Why it stopped: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the CCR8 program.
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 BeiGeneThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935098
- Sponsor's protocol ID
- BGB-A317-A3055-101
- Other IDs
- 2023-505322-34-00, CTR20241681, 2023
- Status last verified
- Mar 2026
- First submitted
- 26 Jun 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeiGene 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. BeiGene 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 BeiGene 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05935098
- Acronym / sponsor ID
- BGB-A317-A3055-101
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Solid Tumor
- Keywords
- BGB-A3055, Tislelizumab, Advanced solid tumors, Safety monitoring, Monoclonal antibody, Preliminary antitumor activity, Metastatic cancer, Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the CCR8 program.
- Enrolment
- 99 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 7 Jul 2023 (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 aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors.
Key details of the study include:
- The study is expected to last about 36 months.
- Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy) | Experimental | Drug: BGB-A3055Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels. |
| Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab) | Experimental | Drug: BGB-A3055, Drug: TislelizumabDifferent groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels. |
| Phase 1b (Dose Expansion): | Experimental | Drug: BGB-A3055, Drug: Tislelizumab, Drug: ChemotherapyParticipants will receive the recommended dose for expansion (RDFE) of BGB-A3055 in combination with tislelizumab with or without chemotherapy to provide additional information on the safety, tolerability, and potential benefits of the recommended dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).
- All participants are also required to demonstrate an ECOG Performance Status score of ≤1 within 3 days before the first dose of study drug(s) and have adequate organ function.
- Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting CCR8.
- >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants should be able to provide archival tumor tissue samples (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints.
Key exclusion criteria (10 listed)
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study drug(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).
- Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection.
- Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA < 500 IU/mL or < 2500 copies/mL) and considered stable are eligible. Participants with a negative HCV antibody test result at screening or a positive HCV antibody test result followed by a negative HCV RNA test result at screening are eligible to participate. Participants with treated HIV infection may be included if certain criteria are met.
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-A3055Administered intravenously | Drug | Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy), Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab), Phase 1b (Dose Expansion): |
| TislelizumabAlso: BGB-A317Administered intravenously | Drug | Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab), Phase 1b (Dose Expansion): |
| ChemotherapyAdministered in accordance with relevant local guidelines and/or prescribing information. | Drug | Phase 1b (Dose Expansion): |
Primary outcome
Phase 1a: Number of participants with adverse events (AEs)
Time frame: Up to 2 Years
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the American Society for Transplantation and Cellular Therapy [ASTCT] consensus grading system for cytokine release syndrome [CRS]), and including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055
Time frame: Up to 2 Years
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered.
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab
Time frame: Up to 2 Years
The RDFEs of BGB-A3055, alone or in combination with tislelizumab will be determined based on biological effectiveness taking preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration.
Phase 1b (Dose Expansion): Objective Response Rate (ORR)
Time frame: Up to 2 Years
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
11 secondary outcomes
Phase 1a: ORR
Time frame: Up to 2 Years
Time to Response (TTR)
Time frame: Up to 2 Years
Duration of Response (DOR)
Time frame: Up to 2 Years
Disease Control Rate (DCR)
Time frame: Up to 2 Years
Clinical Benefit Rate (CBR)
Time frame: Up to 2 Years
Number of participants with anti-drug antibodies (ADAs) against BGB-A3055
Time frame: Up to 2 Years
Serum concentration of BGB-A3055 at specified time points
Time frame: Up to 2 Years
Phase 1b: Progression-Free Survival (PFS)
Time frame: Up to 2 Years
Phase 1b: Number of participants with adverse events (AEs)
Time frame: Up to 2 Years
Phase 1b: Association of CCR8 expression with clinical efficacy
Time frame: Up to 2 Years
Phase 1b: Association of PD-L1 expression with clinical efficacy
Time frame: Up to 2 Years
Results and safety
The study was stopped early (reason given: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the CCR8 program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. BeiGene 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. BeiGene 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 BeiGene 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
BeiGene
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-A3055, Tislelizumab and Chemotherapy in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by BeiGene at 26 sites in 5 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 6 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: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China, United States, South Korea, Australia, France. 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 was stopped early (reason given: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the CCR8 program.). Results are not available in the source record.
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) (time frame: Up to 2 Years). The study lists 4 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 13 Mar 2026.