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HER2 Inhibitor

Personalized Medicine Approaches for Cancer

Phase < 1
Waitlist Available
Led By Lara Davis, M.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of first dose of study drug until death from any cause (until the end of long-term follow-up), ltfu is up to 5 years
Awards & highlights

Summary

This trial is testing if cancer samples can be used to find drugs to control the disease. They will also study the safety and if the drugs have any side effects. Researchers will also study tumor cells to see why some people respond to certain therapies and why some drugs stop working.

Who is the study for?
This trial is for adults with advanced breast, ovarian, prostate, or pancreatic cancer, or sarcomas who have a life expectancy of at least 6 months. They must have measurable lesions after treatment and documented progression after prior therapy. Participants need normal organ function tests and should not be pregnant or breastfeeding. Those with brain metastases, severe infections, other active cancers that could affect the study's outcome are excluded.Check my eligibility
What is being tested?
The SMMART-ACT trial aims to see if precision medicine can find effective drug combinations based on individual cancer samples. It includes testing various drugs like Palbociclib and Trastuzumab among others for safety and effectiveness in controlling disease while also studying why treatments work differently across individuals.See study design
What are the potential side effects?
Potential side effects may include reactions to specific drugs such as fatigue, nausea, blood count changes depending on the intervention used. Since multiple drugs are being tested each participant might experience different side effects based on their personalized treatment regimen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of first dose of study drug until death from any cause (until the end of long-term follow-up), ltfu is up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of first dose of study drug until death from any cause (until the end of long-term follow-up), ltfu is up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who receive an ACT therapy based an ACT Tumor Board recommendation.
Secondary outcome measures
Disease-specific survival
Incidence of treatment-emergent adverse events
Overall response rate (ORR)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SMMART-ACT)Experimental Treatment28 Interventions
Administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation. Combination treatment plans may include a two-week monotherapy lead-in, followed by a combination treatment regimen. Each ACT study intervention must have an established RP2D determined in a prior clinical trial. Participants undergo a Pre-Treatment Biopsy, plus an On-Treatment Biopsy after two weeks on first dose of study drug(s) and prior to starting Cycle 2, regardless of regimen. Participants continue to receive study agent(s) after the On-Treatment Biopsy, according to the biopsy results and the results of ongoing safety and clinical assessments. Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity. Cycles are determined based on the study agent(s). Upon disease progression, participants are given the option to undergo an additional biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
2015
Completed Phase 3
~3540
Trastuzumab
2014
Completed Phase 4
~5190
Paclitaxel
2011
Completed Phase 4
~5380
Niraparib
2018
Completed Phase 4
~1540
Pertuzumab
2014
Completed Phase 3
~7500
Olaparib
2007
Completed Phase 4
~2210
Palbociclib
2017
Completed Phase 3
~3760
Fulvestrant
2011
Completed Phase 3
~3810
Letrozole
2002
Completed Phase 4
~2810
Nab-paclitaxel
2014
Completed Phase 3
~2030
Trastuzumab Emtansine
2016
Completed Phase 3
~5630
Alectinib
2015
Completed Phase 3
~2400
Alpelisib
2018
Completed Phase 3
~900
Anastrozole
2019
Completed Phase 4
~6260
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Capecitabine
2013
Completed Phase 3
~3420
Irinotecan
2017
Completed Phase 4
~2680
Carboplatin
2014
Completed Phase 3
~6670
Cobimetinib
2017
Completed Phase 3
~3070
Entrectinib
2014
Completed Phase 2
~360
Eribulin
2012
Completed Phase 3
~2740
Vinorelbine
2013
Completed Phase 4
~2190
Vismodegib
2015
Completed Phase 4
~1880

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The precision medicine approach for treating pancreatic cancer involves tailoring treatments based on the genetic and molecular profile of the tumor. Common treatments include chemotherapy, which kills rapidly dividing cancer cells by interfering with DNA replication; targeted therapies, such as PARP inhibitors, which exploit defective DNA repair mechanisms in tumors with specific genetic mutations like BRCA1/2; and immunotherapy, which enhances the immune system's ability to recognize and attack cancer cells. This approach is crucial for pancreatic cancer patients as it can lead to more effective and personalized treatment plans, improving outcomes and minimizing side effects.
Molecular biomarkers: their increasing role in the diagnosis, characterization, and therapy guidance in pancreatic cancer.

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
231 Previous Clinical Trials
2,088,490 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,542 Previous Clinical Trials
568,077 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
985 Previous Clinical Trials
7,385,724 Total Patients Enrolled

Media Library

Ado-Trastuzumab Emtansine (HER2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05238831 — Phase < 1
Pancreatic Cancer Research Study Groups: Treatment (SMMART-ACT)
Pancreatic Cancer Clinical Trial 2023: Ado-Trastuzumab Emtansine Highlights & Side Effects. Trial Name: NCT05238831 — Phase < 1
Ado-Trastuzumab Emtansine (HER2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05238831 — Phase < 1
~0 spots leftby May 2026