Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Amino Acids

Capecitabine

Trastuzumab

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Atezolizumab

Ipatasertib

Alectinib

Pertuzumab

Ado-Trastuzumab Emtansine

Pralsetinib

Entrectinib

Tucatinib

Inavolisib

Maytansine

Adenosine

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunotoxins

Immunoconjugates

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Phosphoinositide-3 Kinase Inhibitors

Tyrosine

Participants in this treatment arm must have a positive tumor biomarker result for ROS1 gene fusion.

Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation.

Participants in this treatment arm must have a positive tumor biomarker result for ALK rearrangement tumors.

Participants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.

Participants in this treatment arm must have a positive tumor biomarker result for either tumor mutational burden (TMB) high or microsatellite instability (MSI) high/deficient mismatch repair (dMMR).

Participants in this treatment arm must have a positive tumor biomarker result for ERBB2 mutations or amplification without known TMB high or MSI high/dMMR.

Participants in this treatment arm must have a positive tumor biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.

Participants in this treatment arm must have positive tumor biomarker results for ERBB2 mutation or amplification and TMB high or MSI high/dMMR.

Participants in this treatment arm must have a positive tumor biomarker results for PI3KCA activating mutations and either AKT1/2/3 activating mutation or PTEN loss/loss of function.

Participants in this treatment arm must have a positive tumor biomarker result for either TMB high or MSI high/dMMR.

Participants in this treatment arm must have a positive tumor biomarker result for RET fusion.

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.

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.

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.

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.

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).

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.

Trastuzumab Emtansine

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.

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf

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

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.

Investigator's Choice of Chemotherapy

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.

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.

Tiragolumab

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.

Clinical Trials

This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers.

Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.

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

MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

RANO = Response Assessment in Neuro-Oncology; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response	NCT04632992	Advanced Unrese...	Entrectinib Inavolisib Alectinib Ipatasertib Atezolizumab Trastuzumab Emt... Pertuzumab, Tra... Tucatinib Investigator's ... Paclitaxel Tiragolumab Pralsetinib	18 Years -	Genentech, Inc.
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response	NCT04632992	Advanced Unrese...	Entrectinib Inavolisib Alectinib Ipatasertib Atezolizumab Trastuzumab Emt... Pertuzumab, Tra... Tucatinib Investigator's ... Paclitaxel Tiragolumab Pralsetinib	18 Years -	Genentech, Inc.

Spots Global Cancer Trial Database for advanced unresectable or metastatic solid malignancy