A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Condition: Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Neoplasms
Intervention: TAK-164; 89Zr-TAK-164
Intervention description: TAK-164 intravenous infusion.; 89Zr-TAK-164 intravenous infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum
      tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed measurable advanced and/or metastatic solid
             GI tumor that expresses GCC protein (H-score greater than or equal to [>=] 10), for
             which standard treatment is no longer effective or does not offer curative or
             life-prolonging benefit. For the escalation part of the study (Part A), GI
             malignancies include, but are not limited to, metastatic colorectal carcinoma (mCRC),
             gastric carcinoma, esophageal carcinoma, small intestine cancer, and pancreatic
             cancer. The expansion part of the study (Part B) is limited to participants with CRC
             expressing a high-level of GCC (H-Score >=150) and gastric carcinoma (H-Score >=10).
             Part C includes participants with CRC and gastric carcinoma (H-score >=10 for both
             indications).

             o Part B of the study will be limited to participants with 2 or 3 prior lines of
             systemic standard of care therapy.

          2. Male or female participants 18 years or older.

          3. Adequate bone marrow function, defined as an absolute neutrophil count (ANC) of
             >=1.5*10^9 per liter (/L), platelet count >=100*10^9/L, and hemoglobin >=9 gram per
             deciliter (g/dL). Receiving transfusions or hematopoietic growth factors to meet
             enrollment criteria is not allowed within 14 days preceding the first dose of study
             drug.

          4. Adequate hepatic function with total bilirubin less than or equal to (<=) 1.5* upper
             limit of normal (ULN), serum ALT and AST must be less than (<) 2.5*ULN (AST and ALT
             may be elevated up to 3*ULN if the elevation can be reasonably ascribed to the
             presence of metastatic disease in liver), serum albumin > 3.0 g/dL.

          5. Adequate renal function as defined by creatinine CL >= 60 milliliter per minute
             (mL/min).

          6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

          7. Life expectancy of at least 12 weeks.

          8. Completion of prior chemotherapy, biologic therapy, immunotherapy, or radiation
             therapy at least 4 weeks prior to enrollment.

          9. Resolution of all toxic effects of prior treatments (except alopecia) to Grade <=1 NCI
             CTCAE, version 5.

         10. A portion of participants should have tumors amenable for serial biopsy and a
             willingness to provide consent for pharmacodynamic assessment.

             Additionally for Part C (imaging sub study), participant must fulfill the following
             criteria:

         11. At least 1 extrahepatic metastatic lesion >=2 centimeter (cm) in the longest diameter.

        Exclusion Criteria:

          1. Treatment with anticancer chemotherapy or biologic therapy or with an experimental
             anticancer agent within 28 days of the initial dose of study drug.

          2. Diagnosed or treated for another malignancy within 2 years before administration of
             the first dose of study drug, or previously diagnosed with another malignancy and have
             any evidence of residual disease. Participants with nonmelanoma skin cancer or
             carcinoma in situ of any type are not excluded if they have undergone complete
             resection.

          3. Participant has a history of severe allergic or anaphylactic reactions to recombinant
             proteins or excipients used in TAK-164 formulation or 89Zr-TAK-164 formulation.

          4. Use of strong cytochrome P3A (CYP3A) inhibitors and CYP3A inducers or inhibitors or
             modulators of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within
             1 week before the first dose of study drug.

          5. For participants enrolled in studies in which tumor biopsies are obtained:

               -  Known bleeding diathesis or history of abnormal bleeding, or any other known
                  coagulation abnormalities that would contraindicate the tumor biopsy procedure.

               -  Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin,
                  clopidogrel, heparin, or warfarin).

          6. Participant has concurrent alcohol abuse or a history of drug-induced liver injury
             (DILI).