Advanced Solid TumorsPhase 1/2NCT06459973

A Clinical Study of YL205 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing intravenous (IV) infusion in people with Advanced Solid Tumors, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 43 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients 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 Tumors
What is being tested?: intravenous (IV) infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 43 sitesin 2 countries
Study dates: 4 Jun 2024to 31 Jul 2030
Phase: Phase 1/2
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

1) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).
2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female subjects.
5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors。 6) Patients with positive Napi2b test results at the central laboratory. 9) At least one radiologically evaluable lesion for subjects in Part 1; At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3.
10) Expected survival ≥3 months. 11) Female subjects of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening throughout the study period and for at least 6 months after the last dose of the investigational drug. Male subjects must agree to take effective contraceptive measures and must not undergo sperm cryopreservation or sperm donation from screening throughout the study period and for at least 6 months after the last dose of the investigational drug.
12) subjects must provide tumor samples. 13) Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Who cannot join

1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
3) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.
4) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.
5) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.
6) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.
7) Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.

Show all 18Show fewer

8) Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.
9) Subjects who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.
10) Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.
11) Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
13) Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.
15) Subjects with medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator.
16) Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.
17) Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and a positive titer result.
18) Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20) Subjects with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.
21) Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.
22) Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.
23) Subjects with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid tumors.

Trial locations and contacts

43 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

Sites recruiting now only

43 sites in 2 countries

China32 sites, 32 recruiting

Anyang Cancer Hospital
Anyang, Henan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Peking Union Medical College Hospital
Beijing
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Jilin Provincial Cancer Hospital
Changchun, Jilin
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Hunan Provincial Cancer Hospital
Changsha, Hunan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Chinese People's Liberation Army Army Characterstic Medical Center
Chongqing
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Chongqing Cancer Hospital
Chongqing
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
The Southwest Hospital of AMU
Chongqing
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou, Guangdong
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Hainan General Hospital
Haikou, Hainan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
The First Affiliated Hospital. Zhejiang University School of Medicine
Hangzhou, Zhejiang
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Shandong Cancer Hospital
Jinan, Shandong
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Jingzhou First People's Hospital
Jingzhou, Hubei
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Linyi Cancer Hospital
Linyi, Shandong
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
The People's Hospital of Liaoning Province
Shenyang, Liaoning
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Tongji Medical College of Hust TongJi Hospital
Wuhan, Hubei
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Union hospital Tongji Medical Colllege Huazhong University of School and Technology
Wuhan, Hubei
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an, Shanxi
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Coordinator Clinical operation director, 0512-62858368, clinicaltrials@medilinkthera.com
Recruiting

Other trials in China

United States11 sites, 11 recruiting

Southwest Women's Oncology
Albuquerque, New Mexico, 87109
Coordinator Clinical operation director, +1 505-843-7813, clinicaltrials@medilinkthera.com
Recruiting
Sarah Cannon Research Institute (SCRI)- Denver
Denver, Colorado, 80218
Coordinator Clinical operation director, +1 615-329-7274, clinicaltrials@medilinkthera.com
Recruiting
Florida Cancer Specialists - Lake Mary
Lake Mary, Florida, 32746
Coordinator Clinical operation director, +1 407-804-6133, clinicaltrials@medilinkthera.com
Recruiting
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, 89169
Coordinator Clinical operation director, +1 702-952-3400, clinicaltrials@medilinkthera.com
Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40241
Coordinator Clinical operation director, +1 502-899-3366, clinicaltrials@medilinkthera.com
Recruiting
Sarah Cannon Research (SCRI)-Tennessee
Nashville, Texas, 37203
Coordinator Clinical operation director, +1 615-329-7274, clinicaltrials@medilinkthera.com
Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
Coordinator Clinical operation director, +1 203-785-4095, clinicaltrials@medilinkthera.com
Recruiting
Stephenson Cancer Center (Oklahoma)
Oklahoma City, Oklahoma, 73104
Coordinator Clinical operation director, +1 405-271-1112, clinicaltrials@medilinkthera.com
Recruiting
Providence Cancer Institute - Franz Clinic
Portland, Oregon, 97213
Coordinator Clinical operation director, +1 503-215-5696, clinicaltrials@medilinkthera.com
Recruiting
University of Washington
Seattle, Washington, 98915
Coordinator Clinical operation director, +1 206-543-2100, clinicaltrials@medilinkthera.com
Recruiting
Washington University School of Medicine - Center for advanced Medicine
St Louis, Missouri, 63110
Coordinator Clinical operation director, +1 314-362-5000, clinicaltrials@medilinkthera.com
Recruiting

Other trials in United States

About this study

Official title: A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors

Conditions: Advanced Solid Tumors
Being tested: intravenous (IV) infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intravenous (IV) infusionDrug
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle

Study groups in NCT06459973
Study group	Role	What they receive
Phase Ia: Dose escalation portion	Experimental	YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at several dose levels. Receives: Drug: intravenous (IV) infusion
Phase Ib: Dose expansion portion	Experimental	YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at no less than two dose levels. Receives: Drug: intravenous (IV) infusion
Phase II: Cohort expansion portion	Experimental	YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at RP2D. Receives: Drug: intravenous (IV) infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

To evalue the DLTs
Measured: Approximately within 36 months
To evalue the TEAEs
Treatment Emergent Adverse Event
Measured: Approximately within 36 months
To evalue the TRAEs
Treatment Related Adverse Event
Measured: Approximately within 36 months
To evalue the serious adverse events (SAEs)
Measured: Approximately within 36 months
Determination of the MTD of YL205 in the pivotal clinical study
Measured: Approximately within 36 months
Determination of the RED of YL205 in the pivotal clinical study
Measured: Approximately within 36 months
Determination of the RP2D of YL205 in the pivotal clinical study
Measured: Approximately within 36 months
Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1
Measured: Approximately within 36 months

Secondary outcomes (14)

Characterize the PK parameter AUC
area under curve (AUC)
Measured: Approximately within 36 months
Characterize the PK parameter Cmax
maximum concentration (Cmax)
Measured: Approximately within 36 months
Characterize the PK parameter Ctrough
minimum concentration at trough (Ctrough)
Measured: Approximately within 36 months
Characterize the PK parameter Vd
volume of distribution (Vd)
Measured: Approximately within 36 months
Characterize the PK parameter CL
plasma clearance (CL)
Measured: Approximately within 36 months
Characterize the PK parameter Tmax
time to maximum concentration (Tmax)
Measured: Approximately within 36 months
Characterize the PK parameter t1/2
half-life (t1/2)
Measured: Approximately within 36 months
Assessed the disease control rate (DCR) per RECIST v1.1
(defined as the proportion of CR, PR, or stable disease (SD))
Measured: Approximately within 36 months
Assessed the duration of response (DOR) per RECIST v1.1
Measured: Approximately within 36 months
Assessed the time to response (TTR) per RECIST v1.1
Measured: Approximately within 36 months
Assessed the progression free survival (PFS) per RECIST v1.1
Measured: Approximately within 36 months
Assessed the depth of response (DpR) per RECIST v1.1
the percentage change in target lesion size
Measured: Approximately within 36 months
Assessed the overall survival (OS) per RECIST v1.1
Measured: Approximately within 36 months
Evaluate the corelaton between different levels of Napi2B expression and the sum of CR rate, PR rate and SD rate
Measured: Approximately within 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 202431 Jul 2030

First posted14 Jun 2024
Study start4 Jun 2024
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by MediLink Therapeutics (Suzhou) Co., Ltd.The 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 252 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06459973
Sponsor's protocol ID: YL205-CN-101-01
Status last verified: Dec 2025
First submitted: 30 May 2024
Last updated: 23 Dec 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06459973
Acronym / sponsor ID: YL205-CN-101-01
Conditions: Advanced Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 252 participants (estimated)
Lead sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Jun 2024 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2030 (estimated)
First posted: 14 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase Ia: Dose escalation portion	Experimental	Drug: intravenous (IV) infusionYL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at several dose levels.
Phase Ib: Dose expansion portion	Experimental	Drug: intravenous (IV) infusionYL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at no less than two dose levels.
Phase II: Cohort expansion portion	Experimental	Drug: intravenous (IV) infusionYL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at RP2D.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

1) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).
2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female subjects.
5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors。 6) Patients with positive Napi2b test results at the central laboratory. 9) At least one radiologically evaluable lesion for subjects in Part 1; At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3.
10) Expected survival ≥3 months. 11) Female subjects of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening throughout the study period and for at least 6 months after the last dose of the investigational drug. Male subjects must agree to take effective contraceptive measures and must not undergo sperm cryopreservation or sperm donation from screening throughout the study period and for at least 6 months after the last dose of the investigational drug.
12) subjects must provide tumor samples. 13) Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Key exclusion criteria (18 listed)

1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
3) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.
4) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.
5) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.
6) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.

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
intravenous (IV) infusionYL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle	Drug	Phase II: Cohort expansion portion, Phase Ia: Dose escalation portion, Phase Ib: Dose expansion portion

Primary outcome

To evalue the DLTs
Time frame: Approximately within 36 months
To evalue the TEAEs
Time frame: Approximately within 36 months
Treatment Emergent Adverse Event
To evalue the TRAEs
Time frame: Approximately within 36 months
Treatment Related Adverse Event
To evalue the serious adverse events (SAEs)
Time frame: Approximately within 36 months
Determination of the MTD of YL205 in the pivotal clinical study
Time frame: Approximately within 36 months
Determination of the RED of YL205 in the pivotal clinical study
Time frame: Approximately within 36 months
Determination of the RP2D of YL205 in the pivotal clinical study
Time frame: Approximately within 36 months
Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1
Time frame: Approximately within 36 months

14 secondary outcomes

Characterize the PK parameter AUC
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax
Time frame: Approximately within 36 months
Characterize the PK parameter Ctrough
Time frame: Approximately within 36 months
Characterize the PK parameter Vd
Time frame: Approximately within 36 months
Characterize the PK parameter CL
Time frame: Approximately within 36 months
Characterize the PK parameter Tmax
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2
Time frame: Approximately within 36 months
Assessed the disease control rate (DCR) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the duration of response (DOR) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the time to response (TTR) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the progression free survival (PFS) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the depth of response (DpR) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the overall survival (OS) per RECIST v1.1
Time frame: Approximately within 36 months
Evaluate the corelaton between different levels of Napi2B expression and the sum of CR rate, PR rate and SD rate
Time frame: Approximately within 36 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 23 Dec 2025.

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

Sarah Cannon Research Institute (SCRI)- Denver

Denver, United States

+1 615-329-7274

clinicaltrials@medilinkthera.com

Yale Cancer Center

New Haven, United States

+1 203-785-4095

clinicaltrials@medilinkthera.com

Florida Cancer Specialists - Lake Mary

Lake Mary, United States

+1 407-804-6133

clinicaltrials@medilinkthera.com

43 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intravenous (IV) infusion in people with Advanced Solid Tumors, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 43 sites in 2 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 5 inclusion and 18 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China, 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evalue the DLTs (time frame: Approximately within 36 months). The study lists 8 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 NCT06459973.

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 23 Dec 2025.