## Protocol Section
### Identification Module
**NCT ID:** NCT06428409

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

**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

#### Organization Study ID Info
**ID:** 9999-02A
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-9999-02A
**Type:** OTHER
**Domain:** EU CT
**ID:** 2023-508703-21
**Type:** OTHER
**Domain:** WHO/UTN
**ID:** U1111-1298-8273
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-12-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-12-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-19

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief 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

### Conditions Module

**Conditions:**

- Colorectal Cancer

- Pancreatic Ductal Carcinoma

- Biliary Tract Cancer

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 130

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.

**Intervention Names:**

- Biological: Sacituzumab tirumotecan

- Drug: Fluorouracil (5-FU)

- Drug: Leucovorin (LV) or levoleucovorin

**Label:** Sacituzumab tirumotecan + Chemotherapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancner gets worse or they don't tolerate the treatment.

**Intervention Names:**

- Biological: Sacituzumab tirumotecan

**Label:** Sacituzumab tirumotecan

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sacituzumab tirumotecan

- Sacituzumab tirumotecan + Chemotherapy

**Description:** Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle)

**Name:** Sacituzumab tirumotecan

**Other Names:**

- MK-2870

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Sacituzumab tirumotecan + Chemotherapy

**Description:** 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks

**Name:** Fluorouracil (5-FU)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Sacituzumab tirumotecan + Chemotherapy

**Description:** LV or levoleucovorin is administered by IV infusion every 2 weeks

**Name:** Leucovorin (LV) or levoleucovorin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Number of Participants Who Experience a Dose-limiting Toxicity (DLT)

**Time Frame:** Up to approximately 4 weeks

**Description:** 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.

**Measure:** Number of Participants Who Experience One or More Adverse Events (AEs):

**Time Frame:** Up to approximately 54 months

**Description:** An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.

**Measure:** Number of Participants who Discontinue Study Medication due to an AE

**Time Frame:** Up to approximately 54 months

**Description:** 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.

**Measure:** Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

**Time Frame:** Up to approximately 54 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

**Time Frame:** Up to approximately 54 months

**Description:** 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.

**Measure:** Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR

**Time Frame:** Up to approximately 54 months

**Description:** OS is the length of time from when the participant starts treatment until death from any cause

**Measure:** Overall Survival (OS)

**Time Frame:** Up to approximately 54 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

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

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

### References Module

#### See Also Links

**Label:** Merck Clinical Trials Information

**URL:** https://www.merckclinicaltrials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000018299

- Term: Neoplasms, Ductal, Lobular, and Medullary

- ID: D000010190

- Term: Pancreatic Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M25356

- Name: Carcinoma, Ductal

- Relevance: HIGH

- As Found: Ductal Carcinoma

- ID: M22725

- Name: Carcinoma, Pancreatic Ductal

- Relevance: HIGH

- As Found: Pancreatic Ductal Carcinoma

- ID: M4947

- Name: Biliary Tract Neoplasms

- Relevance: HIGH

- As Found: Biliary Tract Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: HIGH

- As Found: Gastrointestinal Cancer

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T761

- Name: Biliary Tract Cancer

- Relevance: HIGH

- As Found: Biliary Tract Cancer

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001661

- Term: Biliary Tract Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000044584

- Term: Carcinoma, Ductal

- ID: D000021441

- Term: Carcinoma, Pancreatic Ductal

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000931

- Term: Antidotes

- ID: D000020011

- Term: Protective Agents

- ID: D000014803

- Term: Vitamin B Complex

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M6191

- Name: Leucovorin

- Relevance: HIGH

- As Found: Video

- ID: M8600

- Name: Fluorouracil

- Relevance: HIGH

- As Found: According

- ID: M29233

- Name: Levoleucovorin

- Relevance: HIGH

- As Found: IMO-

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M4250

- Name: Antidotes

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: HIGH

- As Found: IMO-

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002955

- Term: Leucovorin

- ID: D000005472

- Term: Fluorouracil

- ID: D000058766

- Term: Levoleucovorin

### Misc Info Module

- Version Holder: 2024-05-31
