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YL202; Toripalimab

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Sep 12, 2025

Target and mechanism

ModalitySmall molecule

Also known as YL202 for injection; Toripalimab injection

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment414

FDA Designations

No designations recorded

Clinical trial landscape

YL202; Toripalimab · 1 trial · 3 indications

Phase 1 1
NCT07169994A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING414 Analytics
PHASE1RECRUITING
A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Nature and frequency of dose-limiting toxicity (DLT)
21 days after the first dose was administered to each subject.

The purpose of DLT is to find maximum tolerated dose (MTD).

Nature and frequency of adverse events (AEs)
42 days after the end of treatment (EOT).

Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.

Secondary Endpoints

Objective response rate (ORR)
Up to approximately 3 years.
Characterize Pharmacokinetics (PK) parameter AUC
Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Cmax
Up to approximately 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
YL202 in combination with ToripalimabEXPERIMENTALPart 1 (dose escalation stage and backfill stage) \& Part 3 (dose expansion stage): YL202 for injection in combination with Toripalimab injection
YL202 in combination with Furmonertinib MesilateEXPERIMENTALPart 2 (dose escalation stage and backfill stage) \& Part 4 (dose expansion stage): YL202 for injection in combination with Furmonertinib Mesilate Tablets

Interventions

NameTypeDescription
YL202 for injection; Toripalimab injectionDRUGPart 1: YL202 and Toripalimab will be administered intravenously. Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined. Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab
YL202 for injection; Furmonertinib Mesilate TabletsDRUGPart 2: YL202 will be administered intravenously,Furmonertinib Mesilate Tablets will be administered orally. Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined. Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF) 2. Able and willing to comply with protocol visits and procedures 3. Aged between 18 to 75 years 4. Eastern Cooperative Oncology Group performance s...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about YL202; Toripalimab

What is YL202 used for?

YL202 is an investigational small molecule being studied for the treatment of advanced solid tumors, including breast cancer and non-small cell lung cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does YL202 target?

YL202 is a small molecule, but its specific molecular target has not been disclosed. The drug is being evaluated in combination with other anti-tumor therapies in patients with advanced solid tumors, and the clinical trial includes biomarker-selected patients.

Who is developing YL202?

YL202 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The company is conducting a Phase 1 clinical trial of YL202 in combination with other anti-tumor therapies for advanced solid tumors.

What phase is YL202 in?

YL202 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants in China.

What clinical trials is YL202 in?

YL202 is being studied in a Phase 1 clinical trial with the identifier NCT07169994. This trial is evaluating YL202 in combination with other anti-tumor therapies in patients with advanced solid tumors, including breast cancer and non-small cell lung cancer, and is currently recruiting participants.

Is YL202 the same as Toripalimab?

YL202 is also known as YL202 for injection and Toripalimab injection. The drug is referred to by these alternative names, and it is being developed by cbdMD, Inc. under the ticker YCBD.