Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Death

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Carboplatin

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants receive single doses of sacituzumab tirumotecan monotherapy once every 2 weeks (Q2W).

Participants receive sacituzumab tirumotecan Q2W in combination with pembrolizumab once every 6 weeks (Q6W).

Participants receive sacituzumab tirumotecan once every 3 weeks (Q3W) during induction and Q2W during maintenance in combination with pembrolizumab Q6W and carboplatin Q3W.

Sacituzumab tirumotecan injection powder for intravenous (IV) infusion.

Sacituzumab tirumotecan

Toll Free Number

Study Coordinator

Medical Director

This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC).

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)

Phase 1 Trial of MK-2870 as Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Subjects With Advanced Solid Tumors

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

A DLT is defined as any of the following: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or lymphopenia; any nonhematologic AE ≥Grade 3 in severity (with some exceptions); any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; a prolonged delay (\>2 weeks) in initiating sacituzumab tirumotecan second dose due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during DLT evaluation period; or any Grade 5 toxicity. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

The AUC of sacituzumab tirumotecan -ADC will be determined in participants from Arm 1.

The Cmax of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The Cmin of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The t½ of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The Tmax of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The CL of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The Vz of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The Rac of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.

The AUC of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The Cmax of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The Cmin of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The t½ of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The Tmax of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The CL of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The Vz of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The Rac of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.

The Cmax of sacituzumab tirumotecan-ADC when coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Cmin of sacituzumab tirumotecan-ADC when coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Rac of sacituzumab tirumotecan-ADC when coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Cmax of sacituzumab tirumotecan-TAB when coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Cmin of sacituzumab tirumotecan-TAB when coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Rac of sacituzumab tirumotecan-TAB when coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Cmax of KL610023 (free payload) when sacituzumab tirumotecan is coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

The Rac of KL610023 (free payload) when sacituzumab tirumotecan is coadministered with pembrolizumab will be determined in participants from Arms 2 and 3.

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause.

The incidence of ADA will be determined in participants from Arms 2 and 3.

Spots Global Cancer Trial Database for Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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