A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Calithera Biosciences, Inc
Study ID
NCT02834247
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Solid Tumors
  • Carcinoma, Non-Small-Cell Lung
  • Head and Neck Carcinoma, Squamous Cell
  • Triple-Negative Breast Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAK-659 — DRUG
    TAK-659 Tablets.
  • Nivolumab — DRUG
    Nivolumab intravenous infusion.

Study Details

The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in participants with advanced solid tumors.

Key Dates

Start date
Aug 12, 2016
Status verified
Feb 2023
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Part 1: Advanced Solid Tumors
    TAK-659 60 milligram (mg), tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 milligram per kilogram (mg/kg), infusion over 60 minutes, intravenously (IV), on Days 1 and 15 in each 28 day treatment cycle until PD or unacceptable toxicity. Dose escalation of TAK-659 to 100 mg may be done using a 3 + 3 dose escalation design to determine a maximum tolerated dose (MTD) and/or RP2D.
  • Experimental: Nivolumab Fixed Dose Cohort
    After RP2D of TAK-659 has been identified, based on evaluation of combination with weight-based dose of nivolumab (3 mg/kg), RP2D may be evaluated in combination with a fixed dose of 240 mg IV nivolumab after discussion between investigator and sponsor for all types of advanced solid tumors. For single-agent nivolumab, fixed dose is expected to have equal exposure, safety, and efficacy as weight-based (3 mg/kg) dose. If nivolumab fixed dose is evaluated with TAK-659 RP2D, 3 participants will be initially enrolled into cohort. Following evaluation of safety, efficacy, and any available PK data, along with discussions between investigator and sponsor, 3 additional participants may be enrolled into cohort for a total of 3 to 6 participants. If \>=1 out of 6 participants experiences dose-limiting toxicity (DLT) in Cycle 1, or significant safety issues are seen in Cycle 2 and beyond, re-evaluation of TAK-659 RP2D when administered with a fixed dose of nivolumab is permitted.
  • Experimental: Part 2: Metastatic Triple-negative Breast Cancer (TNBC)
    Participants with metastatic TNBC will receive TAK-659 at the RP2D as determined in Part 1, tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Day 1 and Day 15 of each 28 day treatment cycle until PD or unacceptable toxicity. A subset of participants will receive two weeks of TAK-659 monotherapy during Cycle 1, and will receive nivolumab beginning on Day 15 of Cycle 1. The dose of nivolumab will be either 3 mg/kg or 240 mg IV, dependent on whether the 240 mg fixed-dose cohort is evaluated and deemed safe and tolerable. If so, the dosing regimen may switch to 240 mg, on the basis of change in clinical practice and discussion between the investigator and sponsor. If the nivolumab fixed-dose evaluation cohort is not run, the dose of nivolumab for all participants in the dose expansion phase will be 3 mg/kg.
  • Experimental: Part 2: Metastatic Non-small Cell Lung Cancer (NSCLC)
    Participants with metastatic NSCLC will receive TAK-659 at the RP2D as determined in Part 1, tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Day 1 and Day 15 of each 28 day treatment cycle until PD or unacceptable toxicity. A subset of participants will receive two weeks of TAK-659 monotherapy during Cycle 1, and will receive nivolumab beginning on Day 15 of Cycle 1.disease or unacceptable toxicity. The dose of nivolumab will be either 3 mg/kg or 240 mg IV, dependent on whether the 240 mg fixed-dose cohort is evaluated and deemed safe and tolerable. If so, the dosing regimen may switch to 240 mg, on the basis of change in clinical practice and discussion between the investigator and sponsor. If the nivolumab fixed-dose evaluation cohort is not run, the dose of nivolumab for all participants in the dose expansion phase will be 3 mg/kg.
  • Experimental: Part 2: Metastatic HNSCC
    Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive TAK-659 at the RP2D as determined in Part 1, tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Day 1 and Day 15 of each 28 day treatment cycle until PD or unacceptable toxicity. A subset of participants will receive two weeks of TAK-659 monotherapy during Cycle 1, and will receive nivolumab beginning on Day 15 of Cycle 1. The dose of nivolumab will be either 3 mg/kg or 240 mg IV, dependent on whether the 240 mg fixed-dose cohort is evaluated and deemed safe and tolerable. If so, the dosing regimen may switch to 240 mg, on the basis of change in clinical practice and discussion between the investigator and sponsor. If the nivolumab fixed-dose evaluation cohort is not run, the dose of nivolumab for all participants in the dose expansion phase will be 3 mg/kg.

Primary Outcome Measure

Part 1, Dose Escalation Phase: Maximum Tolerated Dose (MTD) [ Time Frame: At end of Cycle 1 Day 28 ]

Locations (9)

FacilityCityStateZIPSite coordinators
UCSDLa JollaCalifornia92093-
EmoryAtlantaGeorgia30322-
Massachusetts GeneralBostonMassachusetts2114-
Barbara Ann KarmanosDetroitMichigan48201-
Roswell ParkBuffaloNew York14263-
Fox ChasePhiladelphiaPennsylvania19111-
VanderbiltNashvilleTennessee37232-
Mary Crowley Research CentersDallasTexas75002-
US OncologyFairfaxVirginia22031-

Find similar trials in La Jolla, CA

By research site
UCSD· La Jolla, CAEmory· Atlanta, GAMassachusetts General· Boston, MABarbara Ann Karmanos· Detroit, MIRoswell Park· Buffalo, NYFox Chase· Philadelphia, PA

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