Status:
TERMINATED
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
The drug being tested in this study is a novel antibody-drug conjugate (ADC) called TAK-164. TAK-164 is being evaluated in participants with advanced GCC-positive GI cancer (Part A) or colorectal carc...
Eligibility Criteria
Inclusion
- 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.
- Male or female participants 18 years or older.
- 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.
- 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.
- Adequate renal function as defined by creatinine CL \>= 60 milliliter per minute (mL/min).
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Life expectancy of at least 12 weeks.
- Completion of prior chemotherapy, biologic therapy, immunotherapy, or radiation therapy at least 4 weeks prior to enrollment.
- Resolution of all toxic effects of prior treatments (except alopecia) to Grade \<=1 NCI CTCAE, version 5.
- 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:
- At least 1 extrahepatic metastatic lesion \>=2 centimeter (cm) in the longest diameter.
Exclusion
- Treatment with anticancer chemotherapy or biologic therapy or with an experimental anticancer agent within 28 days of the initial dose of study drug.
- 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.
- 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.
- 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.
- 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).
- Participant has concurrent alcohol abuse or a history of drug-induced liver injury (DILI).
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03449030
Start Date
April 23 2018
End Date
February 27 2020
Last Update
March 22 2021
Active Locations (4)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2621
4
SCRI - Tennessee Oncology Nashville - Southern Hills Clinic
Nashville, Tennessee, United States, 37205