Thoracic Neoplasms, Lung Diseases, Small Cell Lung CarcinomaPhase 1/2NCT07407933
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
A Phase 1/2 study testing YL201 and Atezolizumab in people with Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 38 sites in 9 countries.
Trial summary
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
- What is being tested?
- YL201 and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 38 sitesin 9 countries
- Study dates
- 31 Mar 2026to Feb 2029
- 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
- 1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function
Who cannot join
- No prior systemic anti-cancer treatment for ES-SCLC
- No prior treatment targeting B7H3 or topoisomerase I inhibitor
- No clinically active brain metastases or spinal cord compression
- No current or history of interstitial lung disease (ILD)/ pneumonitis
- No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)
- Other protocol-defined inclusion/ exclusion criteria may apply.
Trial locations and contacts
38 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 9 countries
Spain16 sites, 16 recruiting
- Recruiting
Site 2013
Badajoz, 06080
Study Coordinator
- Recruiting
Site 2012
Badalona, 08916
Study Coordinator
- Recruiting
Site 2014
Barcelona, 08017
Study Coordinator
- Recruiting
Site 2003
Barcelona, 08023
Study Coordinator
- Recruiting
Site 2006
Barcelona, 08028
Study Coordinator
- Recruiting
Site 2001
Barcelona, 08035
Study Coordinator
- Recruiting
Site 2007
Girona, 17007
Study Coordinator
- Recruiting
Site 2002
Madrid, 28034
Study Coordinator
- Recruiting
Site 2005
Madrid, 28040
Study Coordinator
- Recruiting
Site 2019
Madrid, 28050
Study Coordinator
- Recruiting
Site 2004
Madrid, 28223
Study Coordinator
- Recruiting
Site 2011
Madrid, 28850
Study Coordinator
- Recruiting
Site 2010
Manresa, 08242
Study Coordinator
- Recruiting
Site 2008
Seville
Study Coordinator
- Recruiting
Site 2009
Valencia, 46010
Study Coordinator
- Recruiting
Site 2015
Valencia, 46026
Study Coordinator
United States5 sites, 5 recruiting
- Recruiting
Site 1002
Fairfax, Virginia, 22031
Study Coordinator
- Recruiting
Site 1005
Houston, Texas, 77030
Study Coordinator
- Recruiting
Site 1004
Louisville, Kentucky, 40202
Study Coordinator
- Recruiting
Site 1009
Plantation, Florida, 33322
Study Coordinator
- Recruiting
Site 1001
Washington D.C., District of Columbia, 20057
Study Coordinator
France3 sites, 3 recruiting
- Recruiting
Site 1402
Nice, 06189
Study Coordinator
- Recruiting
Site 1404
Paris, 92210
Study Coordinator
- Recruiting
Site 1403
Suresnes, 92150
Study Coordinator
Italy3 sites, 3 recruiting
- Recruiting
Site 1705
Candiolo, 10060
Study Coordinator
- Recruiting
Site 1703
Meldola, 47014
Study Coordinator
- Recruiting
Site 1702
Ravenna, 48121
Study Coordinator
Poland3 sites, 3 recruiting
- Recruiting
Site 1802
Otwock, 05-400
Study Coordinator
- Recruiting
Site 1804
Poznan, 60-569
Study Coordinator
- Recruiting
Site 1801
Przemyśl, 37-700
Study Coordinator
Romania3 sites, 3 recruiting
- Recruiting
Site 1904
Bucharest, 022328
Study Coordinator
- Recruiting
Site 1903
Cluj-Napoca, 400015
Study Coordinator
- Recruiting
Site 1901
Craiova, 109
Study Coordinator
Belgium2 sites, 2 recruiting
- Recruiting
Site 1203
Edegem, 2650
Study Coordinator
- Recruiting
Site 1201
Namur, 5000
Study Coordinator
United Kingdom2 sites, 2 recruiting
- Recruiting
Site 2203
Edinburgh, EH4 2XU
Study Coordinator
- Recruiting
Site 2201
London, W12 0HS
Study Coordinator
Hungary1 site, 1 recruiting
- Recruiting
Site 1601
Kalocsa, 6300
Study Coordinator
About this study
Official title: A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
- Being tested
- YL201, Atezolizumab
- Keywords
- Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab
- Medical subject headings
- Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL201Drug
YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
AtezolizumabDrug
Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W | Experimental | Not described Receives: Drug: YL201; Drug: Atezolizumab |
| YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W | Experimental | Not described Receives: Drug: YL201; Drug: Atezolizumab |
| YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W | Experimental | Not described Receives: Drug: YL201; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and Frequency with Dose-Limiting Toxicities (DLTs)
Measured: 21 days
Adverse Events
Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5
Measured: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Secondary outcomes (9)
ORR
Measured: Up to approximately 3 years
DOR
Measured: Up to approximately 3 years
PFS
Measured: Up to approximately 3 years
OS
Measured: Up to approximately 3 years
AUC
Measured: Up to approximately 3 years
CL
Measured: Up to approximately 3 years
Vss
Measured: Up to approximately 3 years
t1/2
Measured: Up to approximately 3 years
Cmax
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start31 Mar 2026
- Primary completionNov 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Neoplasms, Lung Diseases, Small Cell Lung CarcinomaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche, Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407933
- Sponsor's protocol ID
- YL201-INT-102-02
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07407933
- Acronym / sponsor ID
- YL201-INT-102-02
- Keywords
- Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche, Genentech, Inc.
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 12 Feb 2026 (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 Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W | Experimental | Drug: YL201, Drug: Atezolizumab |
| YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W | Experimental | Drug: YL201, Drug: Atezolizumab |
| YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W | Experimental | Drug: YL201, Drug: Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function
Key exclusion criteria (6 listed)
- No prior systemic anti-cancer treatment for ES-SCLC
- No prior treatment targeting B7H3 or topoisomerase I inhibitor
- No clinically active brain metastases or spinal cord compression
- No current or history of interstitial lung disease (ILD)/ pneumonitis
- No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)
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 |
|---|---|---|
| YL201YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle. | Drug | YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W, YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W, YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W |
| AtezolizumabAtezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle | Drug | YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W, YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W, YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W |
Primary outcome
Nature and Frequency with Dose-Limiting Toxicities (DLTs)
Time frame: 21 days
Adverse Events
Time frame: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5
9 secondary outcomes
ORR
Time frame: Up to approximately 3 years
DOR
Time frame: Up to approximately 3 years
PFS
Time frame: Up to approximately 3 years
OS
Time frame: Up to approximately 3 years
AUC
Time frame: Up to approximately 3 years
CL
Time frame: Up to approximately 3 years
Vss
Time frame: Up to approximately 3 years
t1/2
Time frame: Up to approximately 3 years
Cmax
Time frame: Up to approximately 3 years
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 17 Sep 2026.
- 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.
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YL201 and Atezolizumab in people with Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 38 sites in 9 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 1 inclusion and 6 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Spain, United States, France, Italy, Poland and 4 more countries. 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?
Contact MediLink Study Team (86 0512-62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and Frequency with Dose-Limiting Toxicities (DLTs) (time frame: 21 days). 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?
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 17 Sep 2026.