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YL211

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Roche Holding AG|Trials Updated: Jun 29, 2026

YL211 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2024

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

YL211 clinical trials

YL211 · 1 trial · 1 indication

Phase 1 1
NCT06384352Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING500 Analytics
PHASE1RECRUITING
Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Advanced Solid Tumors
NCT06384352500
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Study Endpoints

Primary Endpoints

Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)
Approximately within 36 months

AE's

Nature and frequency of dose-limiting toxicities (DLTs) (Part 1 and Part 4)
Approximately within 36 months

DLTs

Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 2 and Part 5)
Approximately within 36 months

Safety

ORR assessed using RECIST version 1.1 (Part 2 and Part 5)
Approximately within 36 months

Efficacy

PFS using RECIST version 1.1 defined as the time interval of randomization to the date of first documentation of PD or death due to any cause, whichever occurs first (Part 3 and Part 6)
approximately 36 months

Efficacy

Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 3 and Part 6)
approximately within 36 months

Safety

Secondary Endpoints

physical examination findings (including Eastern Cooperative Oncology Group performance status; ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 1 and Part 4)
Approximately within 36 months
PK enpoints (Part 1 and Part 4)
Approximately within 36 months
Incidence of anti-YL211 antibody (ADA) (Part 1 and Part 4)
Approximately within 36 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTALYL211 Monotherapy Dose Esclation
Part 2EXPERIMENTALYL211 Monotherapy Backfill
Part 3EXPERIMENTALYL211 Monotherapy Dose Expansion
Part 4EXPERIMENTALYL211 + Pembro Combination Therapy Dose Esclation
Part 5EXPERIMENTALYL211 + Pembro Combination Therapy Backfill
Part 6ACTIVE_COMPARATORYL211 + Pembro Combination Therapy or Pembro + Chemo Combination Therapy Dose Expansion

Interventions

NameTypeDescription
YL211DRUGPatients will be treated with YL211 intravenous (IV) infusion only.
YL211+PembrolizumabDRUGPatients will be treated with YL211 and Pembro by infusion.
YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)DRUGparticipants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF. 2. Aged ≥18 years. 3. Be able and willing to comply with protocol visits and procedures. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 5. Adeq...

Countries:United StatesAustraliaCanadaChina
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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