Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive W0180 in a 21-day cycle until the maximum tolerated dose (MTD)/ recommended dose for expansion (RDE) for the single-agent identified.

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) followed by W0180 in a 21-day Cycle until the MTD in combination is identified or an RDE in combination is established.

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion Q3W followed by an RDE dose of W0180 in a 21-day cycle.

Participants will receive W0180 in a 21-day cycle.

W0180

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.

The purpose of this study will be to determine the Maximum Tolerated Dose (MTD) and describe dose-limiting toxicities (DLTs) of W0180 given as monotherapy and in combination with pembrolizumab (anti-PD-1).

First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors

Phase I Dose Escalation and Dose Expansion, International, Multicenter Study of W0180 as Single Agent and in Combination With Pembrolizumab (Anti-PD-1) in Adult Participants With Locally Advanced or Metastatic Solid Tumors

The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

The RDE will be the dose of W0180 chosen for the dose-expansion part.

Treatment-Emergent Adverse Events (TEAEs)/Treatment-Emergent Serious Adverse Events (TESAEs) are any new event that starts after the first administration of study treatment and less than or equal to (\<=) 30 days after treatment discontinuation or that worsened during that study period.

The severity of the AEs are categorized into Grades 1 to 5: Grade 1: Mild- asymptomatic or mild symptoms, Grade 2: Moderate- minimal; local or noninvasive intervention indicated, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, and Grade 5: Death related to AE. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any new event that starts after the first administration of study treatment and \<=30 days after treatment discontinuation or that worsened during that study period.

Number of participants with clinically significant abnormalities in laboratory parameters (hematology, blood chemistry, coagulation parameters, thyroid function, urinalysis, cytokines and tryptase) will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab for both escalation and expansion part of study.

The number of participants reporting dose interruptions, dose reductions, and temporary or definitive discontinuation after administration of W0180 in monotherapy and in combination with pembrolizumab for both escalation and expansion part of study will be assessed.

The duration of study treatment exposure will be summarized after the administration of W0180 in monotherapy and in combination with pembrolizumab for both escalation and expansion part of the study.

Participants with actual and relative dose intensity will be summarized and assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.

The ORR/iORR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).

The DCR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

The iDCR will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).

Cmax will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.

T1/2 will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.

AUC0-t will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.

Total Clearance will be Calculated as the Ratio of the Dose and the total area under the plasma concentration-time curve (AUCinf). CLtot will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.

ORR/iORR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).

The DOR/iDOR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).

The TTR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).

The progression free survival will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

The iPFS will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).

The DCR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

OS is defined as time duration which was measured from the date of first dose to the date of death due to any cause.

Spots Global Cancer Trial Database for w0180

Every month we try and update this database with for w0180 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for w0180

Every month we try and update this database with for w0180 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for w0180 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.