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Tunlametinib+PD-1 mAb

Phase 2

Gastric Adenocarcinoma | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Apr 2, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

Tunlametinib+PD-1 mAb · 1 trial · 1 indication

Phase 2 1
NCT07507526A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric CancerGastric Adenocarcinoma
NOT YET_RECRUITING76 Analytics
PHASE2NOT YET_RECRUITING
A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer
Gastric AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response rate
Up to approximately 24 months

Objective response rate is defined as the proportion of participants who achieve a best overall response of either complete response (CR) or partial response (PR) according to irRECIST (immune-related Response Evaluation Criteria in Solid Tumors) criteria.

Secondary Endpoints

Overall survival
Up to 24 months after last patient enrollment
Progression free survival
Up to approximately 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DTPEXPERIMENTALDisitamab vedotin (RC48): 2.5 mg/kg intravenously on Day 1 of each 14-day cycle Tislelizumab: 400 mg intravenously on Day 1 of each 42-day cycle Tunlametinib: Orally every 12 hours at the dose determined during the safety run-in phase

Interventions

NameTypeDescription
Tunlametinib+PD-1 mAbDRUGDisitamab vedotin (RC48): 2.5 mg/kg intravenously on Day 1 of each 14-day cycle Tislelizumab: 400 mg intravenously on Day 1 of each 42-day cycle Tunlametinib: Orally every 12 hours at the dose determined during the safety run-in phase
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients with advanced gastric cancer who have received at least two lines of prior systemic therapy or are intolerant to standard therapy; HER2 immunohistochemistry (IHC) 2+ or 3+; Presence of measurable target lesions according to irRECIST criteria; Expected survival of at lea...

Countries:China
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Frequently asked questions about Tunlametinib+PD-1 mAb

What is Tunlametinib+PD-1 mAb used for in Gastric Adenocarcinoma?

Tunlametinib+PD-1 mAb is an investigational combination therapy being studied for the treatment of gastric adenocarcinoma. It is currently in Phase 2 clinical development. The combination is being evaluated in a clinical trial for advanced gastric cancer, specifically in patients with gastric adenocarcinoma.

What does Tunlametinib+PD-1 mAb target?

Tunlametinib is a small molecule that targets MEK, a protein in the RAS-RAF-MEK-ERK signaling pathway. The PD-1 mAb component targets programmed cell death protein 1 (PD-1), an immune checkpoint receptor. Together, they are designed to inhibit tumor growth and enhance the immune response against cancer cells.

Who makes Tunlametinib+PD-1 mAb?

Tunlametinib+PD-1 mAb is being developed by BeOne Medicines Ltd., a biopharmaceutical company. The company's stock ticker is ONC. BeOne Medicines is conducting the Phase 2 clinical trial for this combination therapy in gastric adenocarcinoma.

What phase is Tunlametinib+PD-1 mAb in?

Tunlametinib+PD-1 mAb is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The drug is currently being studied in a Phase 2 trial for gastric adenocarcinoma, and its safety and efficacy are still being evaluated.

What clinical trials is Tunlametinib+PD-1 mAb in?

Tunlametinib+PD-1 mAb is being studied in a Phase 2 clinical trial with the identifier NCT07507526. The trial is titled 'A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer' and is expected to enroll 76 participants in China. The trial is not yet recruiting.

Is Tunlametinib+PD-1 mAb the same as Disitamab Vedotin?

No, Tunlametinib+PD-1 mAb is not the same as Disitamab Vedotin. They are separate drugs being studied in combination in the same clinical trial. The trial NCT07507526 evaluates the combination of Disitamab Vedotin, Tunlametinib, and a PD-1 antibody for advanced gastric cancer.