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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Biliary Tract Cancer; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer

Treatments: Drug: Rescue medication; Biological: Sacituzumab tirumotecan; Drug: Supportive care measures; Drug: Fluorouracil (5-FU); Drug: Leucovorin (LV) or levoleucovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06428409

9999-02A

U1111-1298-8273 (Other Identifier)

MK-9999-02A (Other Identifier)

jRCT2031240178 (Registry Identifier)

2023-508703-21 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Sacituzumab tirumotecan + Chemotherapy

Experimental group

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.

Treatment:

Drug: Leucovorin (LV) or levoleucovorin

Drug: Fluorouracil (5-FU)

Drug: Supportive care measures

Biological: Sacituzumab tirumotecan

Drug: Rescue medication

Sacituzumab tirumotecan

Experimental group

Description:

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

Treatment:

Drug: Supportive care measures

Biological: Sacituzumab tirumotecan

Drug: Rescue medication