A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)

Colorectal Cancer Clinical Trial

Official title:

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428409
• Other study ID #: 9999-02A
• Secondary ID: MK-9999-02A2023-
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 19, 2024
• Est. completion date: December 3, 2028

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:

• About the safety and how well people tolerate sacituzumab tirumotecan lone or with chemotherapy

• How many people have the cancer respond (get smaller or go away) to treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 3, 2028
• Est. primary completion date: December 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Has one of the following cancers:

• Unresectable or metastatic colorectal cancer

• Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)

• Advanced and/or unresectable biliary tract cancer (BTC)

• Has received prior therapy for the cancer

• Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• History of severe eye disease

• Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Carcinoma, Ductal
• Carcinoma, Pancreatic Ductal
• Colorectal Cancer
• Gastrointestinal Neoplasms
• Pancreatic Ductal Carcinoma

Intervention

Biological:
• Sacituzumab tirumotecan
Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle)

Drug:
• Fluorouracil (5-FU)
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks
• Leucovorin (LV) or levoleucovorin
LV or levoleucovorin is administered by IV infusion every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experience a Dose-limiting Toxicity (DLT)	A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. DLTs will be measured during Cycle 1 (the first 4 weeks) of treatment.	Up to approximately 4 weeks
Primary	Number of Participants Who Experience One or More Adverse Events (AEs):	An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.	Up to approximately 54 months
Primary	Number of Participants who Discontinue Study Medication due to an AE	An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.	Up to approximately 54 months
Primary	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.	Up to approximately 54 months
Secondary	Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.	Up to approximately 54 months
Secondary	Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR	PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.	Up to approximately 54 months
Secondary	Overall Survival (OS)	OS is the length of time from when the participant starts treatment until death from any cause	Up to approximately 54 months

External Links

•   Merck Clinical Trials Information