Inavolisib for Solid Cancers and Breast Cancer

Recruiting at 15 trial locations

Overseen By Reference Study ID Number: GO39374 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must be taking: Endocrine therapies

Must not be taking: Anti-hyperglycemics, PI3K inhibitors

Disqualifiers: Diabetes, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests inavolisib, an oral drug, in patients with advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer. The drug works by blocking a protein that helps cancer cells grow.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including breast cancer, that have a specific mutation (PIK3CA). Participants must be in good physical condition (ECOG 0 or 1) and expected to live at least 12 weeks. Women with hormone receptor-positive/HER2-negative or HER2-positive breast cancer are eligible. Key exclusions include recent other cancers, significant heart conditions, uncontrolled illnesses, prior treatments with certain drugs, and inability to swallow pills.

Inclusion Criteria

You are expected to live for at least 12 weeks.

I am a woman with advanced breast cancer that is HER2 positive and has a PIK3CA mutation.

I can provide a tissue sample from my cancer for testing.

Exclusion Criteria

I have untreated brain metastases.

I have previously been treated with a CDK4/6 inhibitor.

I have a long QT syndrome or a family history of sudden death related to it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation Stage (Stage I)

Participants receive inavolisib as a single agent or in combination with other therapies to determine the optimal dose

28-35 days per cycle

Multiple visits per cycle

Expansion Stage (Stage II)

Participants receive inavolisib in combination with other therapies based on results from Stage I

28 days per cycle

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fulvestrant
• Inavolisib
• Letrozole
• Metformin
• Palbociclib
• Pertuzumab
• Trastuzumab

Trial Overview The study tests the drug Inavolisib alone or combined with standard therapies for advanced breast cancer. It's an open-label Phase I trial with two stages: dose-escalation to find safe amounts of Inavolisib and expansion to see how well it works across seven different treatment combinations involving drugs like Palbociclib, Letrozole, Fulvestrant, Metformin, Trastuzumab and Pertuzumab.

Participant Groups

Group I: Stage II Arm G: Inavolisib + Trastuzumab + Pertuzumab Experimental Treatment 3 Interventions

Participants will receive inavolisib in combination with trastuzumab and pertuzumab (Days 1-21). Dose of inavolisib will be determined from the results of Stage I Arm A. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group II: Stage II Arm F: Inavolisib + Palbociclib + Fulvestrant + Metformin Experimental Treatment 4 Interventions

Participants will receive inavolisib (Days 1-28) in combination with palbociclib (Days 1-21), fulvestrant (Days 1 and 15 of Cycle 1; Day 1 for subsequent cycles) and metformin (Days 1-28)(Cycle = 28 days). Dose of inavolisib will be determined from the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group III: Stage II Arm E: Inavolisib + Palbociclib + Fulvestrant Experimental Treatment 3 Interventions

Participants will receive inavolisib (Days 1-28) in combination with palbociclib (Days 1-21) and fulvestrant (Days 1 and 15 of Cycle 1; Day 1 for subsequent cycles)(Cycle = 28 days). Dose of inavolisib will be determined from the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group IV: Stage II Arm D: Inavolisib + Fulvestrant Experimental Treatment 2 Interventions

Participants will receive inavolisib on Days 1-28 in combination with fulvestrant on Day 1 and 15 of Cycle 1 and then on Day 1 from Cycle 2 (cycle length: 28 days). Dose of inavolisib will be decided based on the results of Stage I Arm C. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group V: Stage II Arm C: Inavolisib + Letrozole Experimental Treatment 2 Interventions

Participants will receive inavolisib in combination with letrozole on Days 1-28 of each 28-day cycle. Dose of inavolisib will be decided based on the results of Stage I Arm C. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group VI: Stage II Arm B: Inavolisib + Palbociclib + Letrozole Experimental Treatment 3 Interventions

Participants will receive inavolisib on Days 1-28 in combination with palbociclib on Days 1-21 and letrozole on Days 1-28 of each 28-day cycle. Dose of inavolisib will be decided based on the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group VII: Stage I Arm C: Inavolisib + Letrozole Experimental Treatment 2 Interventions

Participants will receive inavolisib in escalating dose levels along with letrozole on Days 1-28 of each 28-day cycle. The starting dose of inavolisib will not exceed the starting dose in Stage I Arm A. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group VIII: Stage I Arm B: Inavolisib + Palbociclib + Letrozole Experimental Treatment 3 Interventions

Participants will receive inavolisib in escalating dose levels (starting dose 3 mg) on Days 1-28, palbociclib on Days 1-21, and letrozole on Days 1-28 of each 28-day cycle. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Group IX: Stage I Arm A: Inavolisib Single Agent Experimental Treatment 1 Intervention

Participants will receive inavolisib in escalating dose levels with starting dose of 6 milligrams (mg). Participants will receive single dose of inavolisib on Day 1 of Cycle 1 followed by once daily from Day 8 of Cycle 1. (Cycle length: 35 days for Cycle 1 and 28 days for all other cycles). Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Inavolisib is already approved in United States for the following indications:

Approved in United States as Itovebi for:

• Locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutations, following recurrence on or after completing adjuvant endocrine therapy

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD