Advanced Unresectable or Metastatic Solid MalignancyPhase 2MyTACTICNCT04632992
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
A Phase 2 study testing Entrectinib, Inavolisib and Alectinib in people with Advanced Unresectable or Metastatic Solid Malignancy, run by Genentech, Inc. at 38 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Unresectable or Metastatic Solid Malignancy
- What is being tested?
- Entrectinib, Inavolisib and Alectinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 38 sitesUnited States
- Study dates
- 13 Jan 2021to 27 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample.
- Evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Life expectancy ≥8 weeks
- Adequate hematologic and end-organ function, as defined in the protocol, obtained within 14 days prior to initiation of study treatment
- Agrees to take measures to prevent pregnancy in the patient or partner
- In addition to the general inclusion criteria above, there are treatment-specific inclusion criteria that apply for each respective treatment arm (as detailed in the protocol)
Who cannot join
- Current participation or enrollment in another therapeutic clinical trial
- Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
- History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
- Wide field radiotherapy within 14 days prior to start of study treatment
- Stereotactic radiosurgery within 7 days prior to start of study treatment
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact patient safety
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- Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1 (androgen blockage may be continued for male patients with prostate cancer)
- Known human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection with status outside of study-allowed criteria
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
- History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
- Major surgical procedure, other than for diagnosis, or significant traumatic injury within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
- Pregnant or breastfeeding, or intending to become pregnant during the study
- In addition to the general exclusion criteria above, there are treatment-specific exclusion criteria that apply for each respective treatment arm (as detailed in the protocol)
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
Messino Cancer Centers
Asheville, North Carolina, 28806
Saint Agnes Hospital - Baltimore - Hunt - PPDS
Baltimore, Maryland, 21229-5201
Hematology and Oncology Clinic
Baton Rouge, Louisiana, 70809
Frontier Cancer Center and Blood Institute
Billings, Montana, 59102
St Luke?s Cancer Institute
Boise, Idaho, 83712
New Jersey Hematology Oncology Associates LLC
Brick, New Jersey, 08724-3009
Gabrail Cancer Center
Canton, Ohio, 44718
Tri County Hematologyoncology
Canton, Ohio, 44718
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, 37404
SCRI Mark H. Zangmeister Center
Columbus, Ohio, 43219
Ascension St. John Hospital
Detroit, Michigan, 48236
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816
California Cancer Associates for Research and Excellence - Encinitas
Encinitas, California, 92024-1328
Northwest Medical Specialties B
Federal Way, Washington, 98003
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33916
The Center for Cancer and Blood Disorders - PPDS
Fort Worth, Texas, 76104-4611
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510-2496
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017
The West Clinic, PC dba West Cancer Center
Memphis, Tennessee, 38138
Pacific Cancer Care - Monterey
Monterey, California, 93940
SCRI Oncology Partners
Nashville, Tennessee, 37203
Central Park Hematology and Oncology
New York, New York, 10028-0506
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360-2740
Arizona Clinical Research Ctr
Oro Valley, Arizona, 85755-6216
Kaiser Permanente Center For Health Research
Portland, Oregon, 97227
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23219
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
San Antonio, Texas, 78229
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, 94118
Sarcoma Oncology Center
Santa Monica, California, 90403
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, 33705-1400
Florida Cancer Specialists - PAN - SCRI - PPDS
Tallahassee, Florida, 32308
Eastchester Center for Cancer Care
The Bronx, New York, 10469
New York Cancer & Blood Specialists
The Bronx, New York, 10469
Kaiser Permanente Medical Ctr
Vallejo, California, 94589
Ventura County Hematology Oncology Specialists
Ventura, California, 93003
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida, 33401-3406
About this study
Official title: 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
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.
- Being tested
- Entrectinib, Inavolisib, Alectinib, Ipatasertib, Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrectinibDrug
Also called Rozlytrek™, RG6268, RO7102122
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.
InavolisibDrug
Also called GDC-0077, RG6114, RO7113755
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.
AlectinibDrug
Also called Alecensa®, RG7853, RO5424802
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.
IpatasertibDrug
Also called GDC-0068, RG7440, RO5532961
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.
AtezolizumabDrug
Also called Tecentriq®, RG7446, RO5541267
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 EmtansineDrug
Also called Kadcyla®, RG3502, RO5304020
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.
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxfDrug
Also called PHESGO™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264
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.
TucatinibDrug
Also called Tukysa™
Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
Investigator's Choice of ChemotherapyDrug
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.
PaclitaxelDrug
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.
TiragolumabDrug
Also called RG6058, RO7092284, MTIG7192A
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.
PralsetinibDrug
Also called GAVRETO™, RG6396, RO7499790
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Entrectinib | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for ROS1 gene fusion. Receives: Drug: Entrectinib |
| Arm B: Inavolisib | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation. Receives: Drug: Inavolisib |
| Arm C: Alectinib | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for ALK rearrangement tumors. Receives: Drug: Alectinib |
| Arm D: Ipatasertib | Experimental | 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. Receives: Drug: Ipatasertib |
| Arm E: Atezolizumab + Investigator's Choice of Chemotherapy | Experimental | 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). Receives: Drug: Atezolizumab; Drug: Investigator's Choice of Chemotherapy |
| Arm F: Trastuzumab Emtansine + Atezolizumab | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) mutations or amplification without known TMB high or MSI high/dMMR. Receives: Drug: Atezolizumab; Drug: Trastuzumab Emtansine |
| Arm G: PH FDC SC | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR. Receives: Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf |
| Arm H: PH FDC SC + Investigator's Choice of Chemotherapy | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR. Receives: Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf; Drug: Investigator's Choice of Chemotherapy |
| Arm I: Trastuzumab Emtansine + Tucatinib | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR. Receives: Drug: Trastuzumab Emtansine; Drug: Tucatinib |
| Arm J: Trastuzumab Emtansine + Atezolizumab | Experimental | Participants in this treatment arm must have positive tumor biomarker results for HER2 mutation or amplification and TMB high or MSI high/dMMR. Receives: Drug: Atezolizumab; Drug: Trastuzumab Emtansine |
| Arm K: Ipatasertib + Atezolizumab | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation. Receives: Drug: Ipatasertib; Drug: Atezolizumab |
| Arm L: Ipatasertib + Atezolizumab | Experimental | 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. Receives: Drug: Ipatasertib; Drug: Atezolizumab |
| Arm M: Ipatasertib + Paclitaxel | Experimental | 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. Receives: Drug: Ipatasertib; Drug: Paclitaxel |
| Arm N: Atezolizumab + Tiragolumab | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for either TMB high or MSI high/dMMR. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Arm O: Pralsetinib | Experimental | Participants in this treatment arm must have a positive tumor biomarker result for RET fusion. Receives: Drug: Pralsetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Primary Central Nervous System (CNS) Tumors
Confirmed objective response rate (cORR)=percentage of participants with best response as complete response (CR) or partial response (PR) for measurable disease \& CR for non-measurable disease. Confirmation=CR/PR on 2 consecutive visits ≥4 weeks apart for 3-week cycles \& ≥6 weeks apart for 4-week cycles. Per RECIST, CR=disappearance of all target lesions. PR= ≥30% decrease in sum of diameters of target lesions, in absence of CR. Per RANO, CR=complete disappearance of all measurable \& non-measurable disease for ≥4 weeks; no new lesions/abnormality on T2/FLAIR imaging; stable/improved non-enhancing lesions; participants must be off corticosteroids or on physiological doses; clinical status stable/improved. PR= ≥50% decrease in the sum of products of perpendicular diameters of measurable enhancing lesions on T2/FLAIR imaging for ≥4 weeks; no progression of non-measurable T1 disease; stable/improved non-enhancing lesions; corticosteroid dose ≤ baseline; clinical status stable/improved.
Measured: Up to 32 months
Secondary outcomes (5)
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
PFS=time from start of treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, per RECIST v1.1, or RANO. Per RECIST, PD=≥20% increase in sum of diameters of lesions, using the smallest sum during the study as reference, including baseline (BL). Per RANO, PD= ≥25% increase in sum of products of perpendicular diameters of enhancing lesions compared to smallest tumor measurement at BL/best response, on stable/increasing corticosteroids (CS) dose; Significant/ ≥25% increase of T2/FLAIR non-enhancing lesion on stable/increasing CS dose compared to BL/best response after therapy start; Presence of new lesions/increase of enhancement; Clear progression of non-measurable disease; Definite clinical deterioration only due to tumor/decrease in CS dose; Failure to return for evaluation due to death/deterioration. Kaplan-Meier methodology was used to estimate PFS; patients without an event were censored on the last available assessment day.
Measured: Time from start of treatment to the first occurrence of disease progression or death from any cause (Up to 32 months)
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
DOR was defined as the time from the date of the first confirmed complete response (CR) or partial response (PR) to disease progression (PD) or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1 or RANO. CR \& PR were defined per RECIST or RANO as outlined in the description for the cORR outcome measure (OM). PD was defined per RECIST or RANO as outlined in the description for the PFS OM. Kaplan-Meier methodology was used to estimate the median DOR. The 95% confidence intervals for the median DOR were computed by the method of Brookmeyer and Crowley. Participants who did not experience death or PD were censored on the day of the last available assessment.
Measured: Time from the date of the first confirmed CR/PR to PD or death from any cause (Up to 32 months)
PFS Rate at Month 3, 6, 9, and 12 as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
The PFS rates were calculated using the Kaplan-Meier (KM) method to estimate the percent survival probability of participants (i.e., PFS event-free: did not experience PD or death from any cause) in each treatment arm at landmark timepoints. The 95% confidence intervals for each PFS rate were computed by the method of Greenwood. PFS was defined as the time from the start of study treatment to the first occurrence of PD or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1 or RANO. PD was defined per RECIST or RANO as outlined in the description for the PFS OM. Participants who did not experience death or PD were censored on the day of the last available assessment. The number analyzed per landmark timepoint actually represents the number of participants who remained at risk of experiencing a PFS event at that timepoint. Percentages are rounded off to the nearest decimal point.
Measured: At Months 3, 6, 9 and 12
Percentage of Participants With Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Disease control rate was defined as the percentage of participants whose best response was confirmed CR, confirmed PR, or a response of CR, PR, stable disease (SD), or non-CR/non-PD for a minimum of 98 days for 28-day cycle arms or 70 days for 21-day cycle arms after the first treatment date. CR \& PR were defined per RECIST/RANO as outlined in the description for the cORR OM. SD per RECIST: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. SD per RANO: Participant does not qualify for CR, PR, or minor response or PD; Stable non-enhancing (T2/FLAIR) lesions or abnormalities on same or lower dose of corticosteroids compared to baseline; No new lesions or new T2 or FLAIR abnormalities apart from those consistent with radiation effect, \& no new or increased enhancement; Participants on a should be corticosteroid dose that is not greater than dose at baseline scan \& is stable or improved clinically; Clinical status, stable/improved.
Measured: Up to 32 months
Number of Participants With at Least One Adverse Event (AE) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
An AE is an untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with the product. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to it. AEs were graded for severity according to NCI CTCAE v5.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3 = Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4= Life-threatening consequences/urgent intervention indicated; Grade 5= Death related to adverse event.
Measured: From initiation of study drug until 28 days after the final dose of study drugs other than atezolizumab and until 90 days after the final dose of atezolizumab (Up to 32 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start13 Jan 2021
- Primary completion4 Dec 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Unresectable or Metastatic Solid MalignancyStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632992
- Sponsor's protocol ID
- ML42439
- Acronym
- MyTACTIC
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2020
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Zuniga RM, VanderWalde A, Schwartzberg LS, Spigel DR, Passler L, Hong J, Howland M, Darbonne WC, Szado T, Daniel D. Impact of community recruitment and inclusion initiatives on enrollment in the biomarker-driven MyTACTIC trial. Future Oncol. 2026 Jan;22(1):59-69. doi: 10.1080/14796694.2025.2595690. Epub 2025 Dec 15.
PubMed 41392942
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04632992
- Acronym / sponsor ID
- MyTACTIC / ML42439
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Arm A: Entrectinib | Experimental | Drug: EntrectinibParticipants in this treatment arm must have a positive tumor biomarker result for ROS1 gene fusion. |
| Arm B: Inavolisib | Experimental | Drug: InavolisibParticipants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation. |
| Arm C: Alectinib | Experimental | Drug: AlectinibParticipants in this treatment arm must have a positive tumor biomarker result for ALK rearrangement tumors. |
| Arm D: Ipatasertib | Experimental | Drug: IpatasertibParticipants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function. |
| Arm E: Atezolizumab + Investigator's Choice of Chemotherapy | Experimental | Drug: Atezolizumab, Drug: Investigator's Choice of ChemotherapyParticipants 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). |
| Arm F: Trastuzumab Emtansine + Atezolizumab | Experimental | Drug: Atezolizumab, Drug: Trastuzumab EmtansineParticipants in this treatment arm must have a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) mutations or amplification without known TMB high or MSI high/dMMR. |
| Arm G: PH FDC SC | Experimental | Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxfParticipants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR. |
| Arm H: PH FDC SC + Investigator's Choice of Chemotherapy | Experimental | Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, Drug: Investigator's Choice of ChemotherapyParticipants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR. |
| Arm I: Trastuzumab Emtansine + Tucatinib | Experimental | Drug: Trastuzumab Emtansine, Drug: TucatinibParticipants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR. |
| Arm J: Trastuzumab Emtansine + Atezolizumab | Experimental | Drug: Atezolizumab, Drug: Trastuzumab EmtansineParticipants in this treatment arm must have positive tumor biomarker results for HER2 mutation or amplification and TMB high or MSI high/dMMR. |
| Arm K: Ipatasertib + Atezolizumab | Experimental | Drug: Ipatasertib, Drug: AtezolizumabParticipants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation. |
| Arm L: Ipatasertib + Atezolizumab | Experimental | Drug: Ipatasertib, Drug: AtezolizumabParticipants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function. |
| Arm M: Ipatasertib + Paclitaxel | Experimental | Drug: Ipatasertib, Drug: PaclitaxelParticipants 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. |
| Arm N: Atezolizumab + Tiragolumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants in this treatment arm must have a positive tumor biomarker result for either TMB high or MSI high/dMMR. |
| Arm O: Pralsetinib | Experimental | Drug: PralsetinibParticipants in this treatment arm must have a positive tumor biomarker result for RET fusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample.
- Evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Life expectancy ≥8 weeks
Key exclusion criteria (15 listed)
- Current participation or enrollment in another therapeutic clinical trial
- Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
- History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
- Wide field radiotherapy within 14 days prior to start of study treatment
- Stereotactic radiosurgery within 7 days prior to start of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntrectinibAlso: Rozlytrek™, RG6268, RO7102122Entrectinib 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 | Arm A: Entrectinib |
| InavolisibAlso: GDC-0077, RG6114, RO7113755Inavolisib 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 | Arm B: Inavolisib |
| AlectinibAlso: Alecensa®, RG7853, RO5424802Alectinib 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 | Arm C: Alectinib |
| IpatasertibAlso: GDC-0068, RG7440, RO5532961Ipatasertib 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 | Arm D: Ipatasertib, Arm K: Ipatasertib + Atezolizumab, Arm L: Ipatasertib + Atezolizumab, Arm M: Ipatasertib + Paclitaxel |
| AtezolizumabAlso: Tecentriq®, RG7446, RO5541267Atezolizumab 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 | Arm E: Atezolizumab + Investigator's Choice of Chemotherapy, Arm F: Trastuzumab Emtansine + Atezolizumab, Arm J: Trastuzumab Emtansine + Atezolizumab, Arm K: Ipatasertib + Atezolizumab, Arm L: Ipatasertib + Atezolizumab, Arm N: Atezolizumab + Tiragolumab |
| Trastuzumab EmtansineAlso: Kadcyla®, RG3502, RO5304020Trastuzumab 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 | Arm F: Trastuzumab Emtansine + Atezolizumab, Arm I: Trastuzumab Emtansine + Tucatinib, Arm J: Trastuzumab Emtansine + Atezolizumab |
| Pertuzumab, Trastuzumab, and Hyaluronidase-zzxfAlso: PHESGO™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264PH 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 | Arm G: PH FDC SC, Arm H: PH FDC SC + Investigator's Choice of Chemotherapy |
| TucatinibAlso: Tukysa™Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards. | Drug | Arm I: Trastuzumab Emtansine + Tucatinib |
| Investigator's Choice of ChemotherapyChemotherapy 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 | Arm E: Atezolizumab + Investigator's Choice of Chemotherapy, Arm H: PH FDC SC + Investigator's Choice of Chemotherapy |
| PaclitaxelThe 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 | Arm M: Ipatasertib + Paclitaxel |
| TiragolumabAlso: RG6058, RO7092284, MTIG7192AFollowing 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 | Arm N: Atezolizumab + Tiragolumab |
| PralsetinibAlso: GAVRETO™, RG6396, RO7499790Pralsetinib 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. | Drug | Arm O: Pralsetinib |
Primary outcome
Confirmed Objective Response Rate (ORR) Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Primary Central Nervous System (CNS) Tumors
Time frame: Up to 32 months
Confirmed objective response rate (cORR)=percentage of participants with best response as complete response (CR) or partial response (PR) for measurable disease \& CR for non-measurable disease. Confirmation=CR/PR on 2 consecutive visits ≥4 weeks apart for 3-week cycles \& ≥6 weeks apart for 4-week cycles. Per RECIST, CR=disappearance of all target lesions. PR= ≥30% decrease in sum of diameters of target lesions, in absence of CR. Per RANO, CR=complete disappearance of all measurable \& non-measurable disease for ≥4 weeks; no new lesions/abnormality on T2/FLAIR imaging; stable/improved non-enhancing lesions; participants must be off corticosteroids or on physiological doses; clinical status stable/improved. PR= ≥50% decrease in the sum of products of perpendicular diameters of measurable enhancing lesions on T2/FLAIR imaging for ≥4 weeks; no progression of non-measurable T1 disease; stable/improved non-enhancing lesions; corticosteroid dose ≤ baseline; clinical status stable/improved.
5 secondary outcomes
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Time frame: Time from start of treatment to the first occurrence of disease progression or death from any cause (Up to 32 months)
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Time frame: Time from the date of the first confirmed CR/PR to PD or death from any cause (Up to 32 months)
PFS Rate at Month 3, 6, 9, and 12 as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Time frame: At Months 3, 6, 9 and 12
Percentage of Participants With Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Time frame: Up to 32 months
Number of Participants With at Least One Adverse Event (AE) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Time frame: From initiation of study drug until 28 days after the final dose of study drugs other than atezolizumab and until 90 days after the final dose of atezolizumab (Up to 32 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41392942Zuniga RM, VanderWalde A, Schwartzberg LS, Spigel DR, Passler L, Hong J, Howland M, Darbonne WC, Szado T, Daniel D. Impact of community recruitment and inclusion initiatives on enrollment in the biomarker-driven MyTACTIC trial. Future Oncol. 2026 Jan;22(1):59-69. doi: 10.1080/14796694.2025.2595690. Epub 2025 Dec 15.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entrectinib, Inavolisib and Alectinib in people with Advanced Unresectable or Metastatic Solid Malignancy, run by Genentech, Inc. at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Primary Central Nervous System (CNS) Tumors (time frame: Up to 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.