Metastatic or Locally Advanced Solid TumorsPhase 1NCT05028556
A Trial of Y101D, a PD-L1/TGF-β Bispecific Antibody, in Patients With Metastatic or Locally Advanced Solid Tumors
A Phase 1 study testing Cohort 1 of Y101D, Cohort 2 of Y101D and Cohort 3 of Y101D in people with Metastatic or Locally Advanced Solid Tumors, run by Wuhan YZY Biopharma Co., Ltd. at 3 sites in China.
Trial summary
This is a phase 1, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of Y101D in patients with metastatic or locally advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic or Locally Advanced Solid Tumors
- What is being tested?
- Cohort 1 of Y101D, Cohort 2 of Y101D and Cohort 3 of Y101D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesChina
- Study dates
- 6 Aug 2021to 9 Sep 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~75 (including 18 and 75 years old), gender is not limited;
- Pathologically confirmed metastatic or locally advanced solid tumors with failure or absence of standard care;
- ECOG physical status score must be 0~1;
- Expected survival of subjects evaluated by the investigator ≥3 months;
- Hemogram: absolute neutrophil count (ANC) ≥1.5×109/L, hemoglobin ≥90g/L (no red blood cells were injected within 14 days before the first administration), platelet ≥90×109/L;
- Liver: bilirubin ≤1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal value;If the subject has liver metastasis, ALT and AST are allowed to be less than 5 times the upper limit of normal value;
- Kidney: Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance ≥ 60 mL/min (using standard Cockcroft-Gault formula);
- Understand and voluntarily sign written informed consent.
Who cannot join
- Have received chemotherapy, radiotherapy (local palliative radiotherapy for 14 days) and immunotherapy within 28 days before the first administration, and have received small molecule targeted drugs or Chinese patent drugs with anti-tumor indications within 14 days;
- Major surgery (except diagnostic biopsy) within 28 days prior to the first dose;
- Subjects with central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention;Patients who had previously received BMs were included if they were asymptomatic ≥4 weeks prior to initial dosing, had stable disease on radiographic findings, and did not require corticosteroid or anticonvulsant therapy;
- Receive any organ transplantation, including allogeneic stem cell transplantation, except those that do not require immunosuppression (e.g. cornea transplantation, hair transplantation);
- Adverse events caused by previous antitumor therapy have not recovered (i.e., grade 1 or at baseline), except for hair loss and grade 2 neuropathy, hormone replacement hypothyroidism, or other confirmed chronic adverse events;
- Subjects with a history of malignancy (non-study tumor) within 3 years prior to the first study administration date (other than skin squamous cell carcinoma and basal cell carcinoma, carcinoma in situ of the cervix or breast, or other non-invasive lesions that the Investigator and Sponsor agree have been cured and have a very low risk of recurrence within 3 years);
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- Have a known allergy, hypersensitivity or intolerance to corticosteroids, monoclonal antibodies or human proteins or their excipients;
- Uncontrolled active infection (CTCAE≥2);
- Subjects with severe respiratory diseases judged by the researcher to be unsuitable for inclusion;
- Subjects with a history of serious cardiovascular disease, including previous coronary artery bypass grafting or stent implantation, myocardial infarction or cerebrovascular accident within 6 months, history of congestive heart failure or unstable angina pectoris, uncontrolled severe hypertension, and arrhythmias requiring medication;
- Active autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus (sle), hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, etc.), into the group when the disease is in stable except ZhuangTaiZhe (no need to systemic immune inhibitors to treat symptoms stable under the condition of more than 6 months).
- Subjects with uncontrolled metabolic diseases such as diabetes, severe gastrointestinal bleeding, and severe diarrhea (CTCAE≥2), and subjects with severe gastrointestinal obstruction requiring intervention;
- Human immunodeficiency virus (HIV) antibody positive, hepatitis B virus (HBV) surface antigen positive and HBV DNA test indicated active hepatitis B (HBV-DNA≥1000cps/ml), active hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analysis method), active syphilis;
- Those who received live (attenuated) virus vaccine within 4 weeks before the first administration;
- Pregnant or lactating women or men or women who have a birth plan within 12 months;
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia;
- Subjects with poor compliance or who are considered by the Investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Cancer Prevention Center, Sun Yat-sen University
Guangzhou, Guangdong
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Henan Cancer Hospital
Zhengzhou, Henan
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of Y101D, a Recombinant Anti-PD-L1 and TGF-β Bispecific Antibody for Injection, in Patients With Metastatic or Locally Advanced Solid Tumors
This is a phase 1, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of Y101D in patients with metastatic or locally advanced solid tumors.
Read the detailed description
This study will consist of two parts: dose escalation part and cohort expansion part.
In dose escalation part, up to 5 dose-escalation cohorts will be sequentially enrolled in this study. The five dose levels are 1, 3, 10, 20 and 30 mg/kg. DLTs will be evaluated during the first treatment cycle, which is 28 days. The study consists of a 4-week screening period, a 4-week core treatment period for DLT evaluation, a treatment extension period, a safety follow-up visit for approximately 30 days following the last dose of Y101D, and survival follow-ups every 3 months thereafter.
In cohort expansion part, To further characterize safety and efficacy of Y101D, cohort expansion will be allowed in the following two circumstances: MTD cohort expansion if the MTD could be identified; Benefited dose cohort if it could be determined by Investigator.
- Being tested
- Cohort 1 of Y101D, Cohort 2 of Y101D, Cohort 3 of Y101D, Cohort 4 of Y101D, Cohort 5 of Y101D
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 of Y101DDrug
Y101D, 1mg/kg, Q2W, intravenous infusion
Cohort 2 of Y101DDrug
Y101D, 3mg/kg, Q2W, intravenous infusion
Cohort 3 of Y101DDrug
Y101D, 10mg/kg, Q2W, intravenous infusion
Cohort 4 of Y101DDrug
Y101D, 20mg/kg, Q2W, intravenous infusion
Cohort 5 of Y101DDrug
Y101D, 30mg/kg, Q2W, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Y101D | Experimental | Y101D in subjects with Metastatic or Locally Advanced Solid Tumors Receives: Drug: Cohort 1 of Y101D; Drug: Cohort 2 of Y101D; Drug: Cohort 3 of Y101D; Drug: Cohort 4 of Y101D; Drug: Cohort 5 of Y101D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0.
Measured: From the time of the first dose (Day 1) until the 2nd dosing (Day 28)
Adverse Events according to CTCAE V5.0
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Time Frame: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 6 months and 28 days)
Secondary outcomes (10)
Area under the curve (AUC) of Y101D
Measured: Up to 1 weeks after the 2nd dosing
Peak Plasma Concentration (Cmax) of Y101D
Measured: Up to 1 weeks after the 2nd dosing
Half-time (t1/2) of Y101D
Measured: Up to 1 weeks after the 2nd dosing
immunogenicity
The presence of antibodies directed against the biotherapeutic medicine upon administration, including the ADA and Nab.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Objective Response Rate (ORR)
ORR is defined as percentage of participants who achieved complete response (CR), partial response (PR), based on RESIST 1.1.
Measured: 6 months (anticipated)
Time to Progression (TTP)
TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression.
Measured: 6 months (anticipated)
Duration of Response
Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in RESIST 1.1.
Measured: 6 months (anticipated)
Progression-Free Survival (PFS)
PFS was defined as the time between the date of first dose of Y101 and either disease progression or death, whichever occurs first.
Measured: 6 months (anticipated)
Overall Survival (OS)
OS was defined as the number of days from administration of the first infusion (Day 1) to date of death.
Measured: 12 months (anticipated)
Time to first Response
Time to first response was defined as the time from the date of first dose of Y101 to the date of initial documentation of a response (PR or better).
Measured: 6 months (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start6 Aug 2021
- Primary completion5 Jul 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic or Locally Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan YZY Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, MD, Principal investigator, Cancer Prevention Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028556
- Sponsor's protocol ID
- Y101D01
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2021
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun H, Chen G, Xue J, Zhang Y, Ma Y, Yang Y, Fang W, Zhao Y, Huang Y, Hong S, Zhou T, Zhao S, Zhou H, Chen X, Li J, Zhang L, Zhao H. Phase I study of Y101D, a bispecific antibody targeting PD-L1 and TGF-beta in patients with advanced solid tumors. Oncologist. 2026 May 8;31(6):oyag133. doi: 10.1093/oncolo/oyag133.
PubMed 42104927
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of Y101D, a Recombinant Anti-PD-L1 and TGF-β Bispecific Antibody for Injection, in Patients With Metastatic or Locally Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05028556
- Acronym / sponsor ID
- Y101D01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wuhan YZY Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 31 Aug 2021 (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 phase 1, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of Y101D in patients with metastatic or locally advanced solid tumors.
Detailed description
This study will consist of two parts: dose escalation part and cohort expansion part.
In dose escalation part, up to 5 dose-escalation cohorts will be sequentially enrolled in this study. The five dose levels are 1, 3, 10, 20 and 30 mg/kg. DLTs will be evaluated during the first treatment cycle, which is 28 days. The study consists of a 4-week screening period, a 4-week core treatment period for DLT evaluation, a treatment extension period, a safety follow-up visit for approximately 30 days following the last dose of Y101D, and survival follow-ups every 3 months thereafter.
In cohort expansion part, To further characterize safety and efficacy of Y101D, cohort expansion will be allowed in the following two circumstances: MTD cohort expansion if the MTD could be identified; Benefited dose cohort if it could be determined by Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y101D | Experimental | Drug: Cohort 1 of Y101D, Drug: Cohort 2 of Y101D, Drug: Cohort 3 of Y101D, Drug: Cohort 4 of Y101D, Drug: Cohort 5 of Y101DY101D in subjects with Metastatic or Locally Advanced Solid Tumors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18~75 (including 18 and 75 years old), gender is not limited;
- Pathologically confirmed metastatic or locally advanced solid tumors with failure or absence of standard care;
- ECOG physical status score must be 0~1;
- Expected survival of subjects evaluated by the investigator ≥3 months;
- Hemogram: absolute neutrophil count (ANC) ≥1.5×109/L, hemoglobin ≥90g/L (no red blood cells were injected within 14 days before the first administration), platelet ≥90×109/L;
Key exclusion criteria (17 listed)
- Have received chemotherapy, radiotherapy (local palliative radiotherapy for 14 days) and immunotherapy within 28 days before the first administration, and have received small molecule targeted drugs or Chinese patent drugs with anti-tumor indications within 14 days;
- Major surgery (except diagnostic biopsy) within 28 days prior to the first dose;
- Subjects with central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention;Patients who had previously received BMs were included if they were asymptomatic ≥4 weeks prior to initial dosing, had stable disease on radiographic findings, and did not require corticosteroid or anticonvulsant therapy;
- Receive any organ transplantation, including allogeneic stem cell transplantation, except those that do not require immunosuppression (e.g. cornea transplantation, hair transplantation);
- Adverse events caused by previous antitumor therapy have not recovered (i.e., grade 1 or at baseline), except for hair loss and grade 2 neuropathy, hormone replacement hypothyroidism, or other confirmed chronic adverse events;
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 |
|---|---|---|
| Cohort 1 of Y101DY101D, 1mg/kg, Q2W, intravenous infusion | Drug | Y101D |
| Cohort 2 of Y101DY101D, 3mg/kg, Q2W, intravenous infusion | Drug | Y101D |
| Cohort 3 of Y101DY101D, 10mg/kg, Q2W, intravenous infusion | Drug | Y101D |
| Cohort 4 of Y101DY101D, 20mg/kg, Q2W, intravenous infusion | Drug | Y101D |
| Cohort 5 of Y101DY101D, 30mg/kg, Q2W, intravenous infusion | Drug | Y101D |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: From the time of the first dose (Day 1) until the 2nd dosing (Day 28)
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0.
Adverse Events according to CTCAE V5.0
Time frame: Time Frame: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 6 months and 28 days)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
10 secondary outcomes
Area under the curve (AUC) of Y101D
Time frame: Up to 1 weeks after the 2nd dosing
Peak Plasma Concentration (Cmax) of Y101D
Time frame: Up to 1 weeks after the 2nd dosing
Half-time (t1/2) of Y101D
Time frame: Up to 1 weeks after the 2nd dosing
immunogenicity
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Objective Response Rate (ORR)
Time frame: 6 months (anticipated)
Time to Progression (TTP)
Time frame: 6 months (anticipated)
Duration of Response
Time frame: 6 months (anticipated)
Progression-Free Survival (PFS)
Time frame: 6 months (anticipated)
Overall Survival (OS)
Time frame: 12 months (anticipated)
Time to first Response
Time frame: 6 months (anticipated)
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 20 Jul 2025.
- Derived from this study: PubMed 42104927Sun H, Chen G, Xue J, Zhang Y, Ma Y, Yang Y, Fang W, Zhao Y, Huang Y, Hong S, Zhou T, Zhao S, Zhou H, Chen X, Li J, Zhang L, Zhao H. Phase I study of Y101D, a bispecific antibody targeting PD-L1 and TGF-beta in patients with advanced solid tumors. Oncologist. 2026 May 8;31(6):oyag133. doi: 10.1093/oncolo/oyag133.
- Individual participant dataSharing planned: No
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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.
Li Zhang, MD principal investigator
Cancer Prevention Center, Sun Yat-sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1 of Y101D, Cohort 2 of Y101D and Cohort 3 of Y101D in people with Metastatic or Locally Advanced Solid Tumors, run by Wuhan YZY Biopharma Co., Ltd. at 3 sites in China.
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 17 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Dose Limiting Toxicities (DLTs) (time frame: From the time of the first dose (Day 1) until the 2nd dosing (Day 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028556, which also lists 1 linked publication.
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 20 Jul 2025.