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YL201

Phase 1

Small Cell Lung Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: May 20, 2026

Target and mechanism

Molecular targetB7-H3
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

YL201 · 1 trial · 1 indication

Phase 1 1
NCT06898957Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)Small Cell Lung Cancer
ACTIVE NOT_RECRUITING29 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Dose-limiting toxicities (DLTs)
Up to Day 21
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 3.5 Years

Secondary Endpoints

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Up to 3.5 Years
Duration of Response (DOR) per RECIST 1.1
Up to 3.5 Years
Time to Response (TTR) per RECIST 1.1
Up to 3.5 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Exploration (Part 1)EXPERIMENTALMultiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.
Dose Expansion (Part 2)EXPERIMENTALYL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.
Triplet Combination (Part 3)EXPERIMENTALYL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) administered IV at a fixed dose.

Interventions

NameTypeDescription
YL201DRUGYL201 will be administered as an IV infusion.
TarlatamabDRUGTarlatamab will be administered as an IV infusion.
DurvalumabDRUGDurvalumab will be administered as an IV infusion.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC. * For Parts 1 and 2, subjects must have ES-SCLC that has progressed or recurred following at least 1 p...

Countries:United StatesCanadaChinaFranceGermanyGreeceHungaryItalySouth KoreaSpain
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Small Cell Lung Cancer")

Frequently asked questions about YL201

What is YL201 used for in Small Cell Lung Cancer?

YL201 is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer (SCLC). It is currently in Phase 1 clinical development, evaluated in combination with tarlatamab, with or without an anti-PD-L1 agent, in participants with extensive stage SCLC.

What does YL201 target?

YL201 targets B7-H3, a protein involved in tumor biology. By targeting B7-H3, YL201 is designed to interfere with this protein's activity in cancer cells. It is being studied as part of combination therapy for Small Cell Lung Cancer.

Who makes YL201?

YL201 is being developed by Amgen Inc. (NASDAQ: AMGN). The company is conducting a Phase 1 clinical trial of YL201 in combination with tarlatamab for the treatment of extensive stage Small Cell Lung Cancer.

What phase is YL201 in?

YL201 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 29 patients.

What clinical trials is YL201 in?

YL201 is being studied in one Phase 1 clinical trial, identified as NCT06898957. This trial evaluates YL201 in combination with tarlatamab, with or without an anti-PD-L1 agent, in participants with extensive stage Small Cell Lung Cancer. The study is active but not recruiting.

Is YL201 the same as tarlatamab?

No, YL201 is not the same as tarlatamab. YL201 is a small molecule targeting B7-H3, while tarlatamab is a separate investigational agent. In the ongoing Phase 1 trial, YL201 is being studied in combination with tarlatamab for Small Cell Lung Cancer.