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

Phase 2TerminatedNCT05220098

Takeda69 enrolled

Overview

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.

This study consists of 2 phases: Dose-escalation and cohort-expansion phase. Dose-escalation phase: The purpose of the dose-escalation phase is to generate data to characterize the initial safety and tolerability profile of TAK-280 and determine the 2 recommended doses for expansion (RDEs) of TAK-280 to be administered during the cohort-expansion phase. Cohort-Expansion Phase: The cohort expansion phase will be conducted in 3 indications. Only in 1 selected indication participants will be randomized 1:1 to receive either TAK-280 high dose or low dose. In the remaining 2 indications to be studied in the cohort-expansion phase, participants will receive only one dose level of TAK-280.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unresectable Locally Advanced or Metastatic Cancer

Interventions

TAK-280DRUG

Participants will receive TAK-280 as IV infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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. 1. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers. 2. 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. Exclusion Criteria * 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.

Locations (23)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Number of Participants With Dose Limiting Toxicities (DLTs)

DLT evaluation period is defined as the time between the initial dose of TAK-280 and Cycle 1 Day 28.

Time frame: From start of the initial dose up to Cycle 1 Day 28

Number of Participants With Treatment- emergent Adverse Events (TEAEs)

Time frame: Up to approximately 37 months

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax) of TAK-280

Cmax of TAK-280 will be reported.

Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)

Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280

AUC of TAK-280 will be reported.

Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)

Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280

tmax of TAK-280 will be reported.

Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)

Terminal Disposition Phase Half-Life (t1/2) of TAK-280

t1/2 of TAK-280 will be reported.

Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)

Total Clearance (CL) of TAK-280

CL of TAK-280 will be reported.

Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)

Data from ClinicalTrials.gov

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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

...and 13 more locations

Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280

Vss of TAK-280 will be reported.

Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)

Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

ORR is defined as the percentage of participants who achieve confirmed complete response (CR) or partial response (PR) based on RECIST V1.1 as determined by the investigator during the study.

Time frame: Up to approximately 37 months

Duration of Response (DOR) Based on RECIST V1.1

DOR is defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first, for participants with a confirmed response (PR or better).

Time frame: Up to approximately 37 months

Progression Free Survival (PFS)

PFS is defined as the time from the date of the first dose of TAK-280 to the date of first documentation of PD or death due to any cause, whichever occurs first.

Time frame: From start of first dose to disease progression or death, whichever occurred first (up to approximately 37 months)

Overall Survival (OS)

OS is defined as the time from the date of the first dose of TAK-280 to the date of death due to any cause.

Time frame: From start of first dose of study drug up to death (up to approximately 37 months)

Disease Control Rate

Disease control rate is defined as the percentage of participants who achieve PR or CR or SD, with a duration of greater than or equal to (\>=) 2 consecutive scans.

Time frame: Up to approximately 37 months

Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response

PSA response is defined as PSA reduction from baseline of \>= 50 percent (%) and confirmed at least 3 weeks later.

Time frame: Up to approximately 37 months

Duration of PSA Response in Participants With mCRPC

Duration of PSA response is defined as the time from first PSA response to first documented PSA progression.

Time frame: Up to approximately 37 months

Time to PSA Progression in Participants With mCRPC

Time to PSA progression is defined as the time from the date of first dose of TAK-280 to the date that an increase of 25% or more and absolute increase of 2 nanograms/milliliter (ng/mL) or more from the nadir.

Time frame: Up to approximately 37 months

Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months

Time frame: Baseline up to 6 months

Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280

Time frame: Cycle 1 to 5: pre-dose (Each cycle= 28 days)

Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280

Time frame: Cycle 1 to 5: pre-dose (Each cycle= 28 days)