First-in-Human Study of TAK-280 in Participants With Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Unresectable Locally Advanced or Metastatic Cancer

In brief

The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days. After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.

Key facts

Study ID: NCT05220098
Run by: Takeda
People needed: 69
Starts: 2022-04-21
Expected to finish: 2025-07-28
Last updated by the study team: 2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable.
Criteria for disease state in dose escalation and cohort expansion.
Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms.
Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1.
Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was >=6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.

You may not qualify if…

History of known autoimmune disease.
Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.
Unhealed wounds from surgery or injury.
Ongoing or active infection of Grade >=2.
Oxygen saturation less than (<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment.
Inflammatory process that has not resolved for >= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration.
Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
Known hypersensitivity to TAK-280 or any excipient.

Where it is running

University of Arkansas For Medical Sciences — Little Rock, Arkansas, United States
University of California San Francisco — San Francisco, California, United States
University of Minnesota - Masonic Cancer Center — Minneapolis, Minnesota, United States
Duke Cancer Institute — Durham, North Carolina, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Sanford Cancer Center — Sioux Falls, South Dakota, United States
Avera Cancer Institute — Sioux Falls, South Dakota, United States
SCRI Tennessee Oncology Nashville — Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Froedtert and The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse Hospital — Camperdown, New South Wales, Australia
Southern Oncology Clinical Research Unit — Bedford Park, Australia
Monash Medical Centre — Clayton, Australia
Cabrini Health — Malvern, Australia
Centre Intégré de Cancérologie du CHU de Québec - Université Laval — Québec, Canada
Centre Hospitalier Universitaire de Sherbrooke CHUS — Sherbrooke, Canada
Hospital Quironsalud Barcelona, NEXT Oncology — Barcelona, Spain
Hospital Universitari Dexeus - Grupo Quironsalud — Barcelona, Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain
START MADRID_Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Universitario Virgen de la Victoria — Málaga, Spain
Hospital Clinico Universitario de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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