Only 33 spots left

~33 spots leftby Dec 2026

Inavolisib for Solid Cancers and Breast Cancer

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Approved in 1 Jurisdiction

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.

See 8 more

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.

See 18 more

Treatment Details

Interventions

Fulvestrant (Estrogen Receptor Antagonist)
Inavolisib (PI3K Inhibitor)
Letrozole (Aromatase Inhibitor)
Metformin (Biguanide)
Palbociclib (CDK4/6 Inhibitor)
Pertuzumab (Monoclonal Antibodies)
Trastuzumab (Monoclonal Antibodies)

Trial OverviewThe 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

9Treatment groups

Experimental Treatment

Group I: Stage II Arm G: Inavolisib + Trastuzumab + PertuzumabExperimental Treatment3 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 + MetforminExperimental Treatment4 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 + FulvestrantExperimental Treatment3 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 + FulvestrantExperimental Treatment2 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 + LetrozoleExperimental Treatment2 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 + LetrozoleExperimental Treatment3 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 + LetrozoleExperimental Treatment2 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 + LetrozoleExperimental Treatment3 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 AgentExperimental Treatment1 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