A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

PHASE2CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

January 13, 2021

Primary Completion Date

December 4, 2023

Study Completion Date

February 27, 2024

Conditions
Advanced Unresectable or Metastatic Solid Malignancy
Interventions
DRUG

Entrectinib

Entrectinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 600 milligrams (mg) per day once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.

DRUG

Inavolisib

Inavolisib will be self-administered by participants orally at home (except on clinic days) at the same time each day, on a starting dose of 9 mg/day QD until disease progression, intolerable toxicity, or consent withdrawal.

DRUG

Alectinib

Alectinib will be self-administered by participants orally at home (except on clinic days), at the same times each day, on a starting dose of 600 mg twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal.

DRUG

Ipatasertib

Ipatasertib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg QD until disease progression, intolerable toxicity, or consent withdrawal.

DRUG

Atezolizumab

Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).

DRUG

Trastuzumab Emtansine

Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.

DRUG

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf

PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.

DRUG

Tucatinib

Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.

DRUG

Investigator's Choice of Chemotherapy

Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines.

DRUG

Paclitaxel

The dose of paclitaxel is 80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. The paclitaxel infusion will be delivered over at least 60 minutes for each dose per institutional guidelines and administered after the oral dose of ipatasertib.

DRUG

Tiragolumab

Following the administration of atezolizumab and an observation period, participants will receive 600 mg tiragolumab at a fixed dose administered by IV infusion on Day 1 of each 21-day cycle.

DRUG

Pralsetinib

Pralsetinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg/day (four 100-mg capsules per day) once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.

Trial Locations (38)

10469

Eastchester Center for Cancer Care, The Bronx

New York Cancer & Blood Specialists, The Bronx

23219

Virginia Commonwealth University - Massey Cancer Center, Richmond

28806

Messino Cancer Centers, Asheville

32308

Florida Cancer Specialists - PAN - SCRI - PPDS, Tallahassee

33916

SCRI Florida Cancer Specialists South, Fort Myers

37203

SCRI Oncology Partners, Nashville

37404

Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga

38138

The West Clinic, PC dba West Cancer Center, Memphis

43219

SCRI Mark H. Zangmeister Center, Columbus

44718

Gabrail Cancer Center, Canton

Tri County Hematologyoncology, Canton

48236

Ascension St. John Hospital, Detroit

59102

Frontier Cancer Center and Blood Institute, Billings

70809

Hematology and Oncology Clinic, Baton Rouge

71913

Genesis Cancer Center, Hot Springs

78229

Mays Cancer Center at UT Health San Antonio MD Anderson Cancer, San Antonio

83712

St Luke?s Cancer Institute, Boise

90017

Los Angeles Hematology Oncology Medical Group, Los Angeles

90403

Sarcoma Oncology Center, Santa Monica

93003

Ventura County Hematology Oncology Specialists, Ventura

93940

Pacific Cancer Care - Monterey, Monterey

94118

Kaiser Permanente - San Francisco Medical Center, San Francisco

94589

Kaiser Permanente Medical Ctr, Vallejo

97227

Kaiser Permanente Center For Health Research, Portland

98003

Northwest Medical Specialties B, Federal Way

99508

Alaska Oncology and Hematology, Anchorage

85755-6216

Arizona Clinical Research Ctr, Oro Valley

92024-1328

California Cancer Associates for Research and Excellence - Encinitas, Encinitas

06360-2740

Eastern CT Hematology and Oncology Associates, Norwich

33705-1400

Florida Cancer Specialists - NORTH - SCRI - PPDS, St. Petersburg

33401-3406

Florida Cancer Specialists - EAST - SCRI - PPDS, West Palm Beach

21229-5201

Saint Agnes Hospital - Baltimore - Hunt - PPDS, Baltimore

68510-2496

Southeast Nebraska Cancer Center, Lincoln

08724-3009

New Jersey Hematology Oncology Associates LLC, Brick

08816

Astera Cancer Care East Brunswick, East Brunswick

10028-0506

Central Park Hematology and Oncology, New York

76104-4611

The Center for Cancer and Blood Disorders - PPDS, Fort Worth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT04632992 - A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response | Biotech Hunter | Biotech Hunter