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Clinical Trial 19460

Cancer Type: Gastrointestinal Tumor
Interventions:TAK-164

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Richard Kim

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C

Summary

The purpose of this study is to: Test the safety of the research study drug, TAK-164 and to find out the highest, safest dose that can be given to study participants. Obtain information on the amount of TAK-164 in the blood after taking doses of the study drug. Understand how well the participant's cancer and their body respond to TAK-164.

Objective

The Primary Objective is: To evaluate the safety of TAK-164 and to determine the MTD and recommended phase 2 dose and schedule. The Secondary Objectives are: To characterize the PK of TAK-164. To evaluate immunogenicity of TAK-164. To evaluate efficacy of TAK-164 as measured by overall response rate (ORR). To evaluate other efficacy measures such as DCR, which includes response (Complete response [CR]+partial response [PR]) plus stable disease, DOR, and PFS. The Exploratory Objectives are: To characterize the molecular profile of patients (including gene expression, IHC, cell-free DNA and others) and to assess relationships with clinical response. To evaluate the pharmacodynamic effect of TAK-164 in tumor and/or liquid biopsies as part of the expansion phase (Part B).

Inclusion Criteria

  • Histologically or cytologically confirmed measurable advanced and/or metastatic solid gastrointestinal (GI) tumor that expresses guanylyl cyclase C (GCC) protein (H-score greater than [>] 10), for which standard treatment is no longer effective for whom there is no available standard therapy. 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 colorectal cancer/carcinoma (CRC).
  • Male or female participants 18 years or older.
  • Adequate bone marrow function, defined as an absolute neutrophil count (ANC) of greater than or equal to (>=) 1.5 x10^9 per liter (/L), platelet count >=100 x10^9/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.
  • 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 less than or equal to 1 NCI CTCAE, Version 5.
  • A portion of patients should have tumors amenable for serial biopsy and a willingness to provide consent for pharmacodynamics assessment.

  • Exclusion Criteria

  • Pregnant or breastfeeding patients or patients who have a positive serum pregnancy test during the screening period.
  • Chronic or active infection requiring systemic therapy, as well as a history of symptomatic viral infection which has not been fully cured.
  • Symptomatic CNS malignancy or metastasis. Screening of asymptomatic patients without history of CNS metastases is not required.
  • History of congestive heart failure.
  • 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.
  • 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.
  • Additional criteria may apply