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Monoclonal Antibodies
New Treatments for Metastatic Breast Cancer (PRE-I-SPY-PI Trial)
Phase 1
Recruiting
Led By Paula R Pohlmann, MD, MSc, PhD
Research Sponsored by QuantumLeap Healthcare Collaborative
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status Grade 0-2
Age ≥ 18 years at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of treatment to 12 months
Awards & highlights
PRE-I-SPY-PI Trial Summary
This trial tests new treatments for metastatic breast cancer with the goal of moving promising drug regimens into other trials quickly.
Who is the study for?
This trial is for adults with breast cancer who have a life expectancy over 12 weeks and can follow the study plan. They must not be pregnant, should agree to use contraception, and have recovered from previous treatments. People with uncontrolled brain cancer, recent major surgery, or severe illnesses that affect study participation cannot join.Check my eligibility
What is being tested?
The I-SPY Phase I/Ib trial tests new drugs (Tucatinib, Zanidatamab, Fam-Trastuzumab Deruxtecan-Nxki, ALX148) alone or in combinations for metastatic breast cancer. It aims to identify effective treatments quickly for further trials.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, allergic reactions and possibly organ-specific issues depending on each drug's profile.
PRE-I-SPY-PI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
PRE-I-SPY-PI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Response (DOR)
Incidence of Adverse Events related to the treatment
Incidence of Dose Limiting Toxicities (DLTs) at each dose level
+3 moreSecondary outcome measures
Clinical Benefit Rate (CBR) at 6 months
Progression Free Survival (PFS) - descriptive
PRE-I-SPY-PI Trial Design
2Treatment groups
Experimental Treatment
Group I: PRE2 Zanidatamab (ZW25, zani) + Tucatinib (TUKYSA®)Experimental Treatment2 Interventions
Zanidatamab is a bispecific IgG1-like antibody directed against two distinct HER2 epitopes. It induces formation of receptor clusters and internalization resulting in downregulation. It also inhibits growth factor-dependent and -independent tumor cell proliferation as well as potently activating ADCC, ADCP, and CDC.
Tucatinib is a highly selective, small molecule tyrosine kinase inhibitor (TKI) of HER2 compared to other TKI's (i.e., EGFR). It is well tolerated, crosses the blood brain barrier and can treat CNS disease. It is FDA approved for HER2+ breast cancer.
Given the promising clinical data for each of these drugs which have different mechanisms, the effect of zanidatamab after T-DXd (Enhertu®) in breast cancer patients, and the favorable toxicity profile of both drugs, we hypothesize that the combination of tucatinib and zanidatamab will be well tolerated and more efficacious than either drug alone for the treatment of patients with HER2 positive breast cancer.
Group II: PRE1 ALX148 (Evorpacept) + Fam-Trastuzumab Deruxtecan-Nxki (T-DXd, Enhertu®)Experimental Treatment2 Interventions
The combination of T-DXd and ALX148 aims to explore the anti-tumoral effects of trastuzumab, of the topoisomerase inhibitor DXd and of the CD47-blocking agent ALX148. The rationale for this combination is that ALX148 is hypothesized, based on preclinical data, to facilitate antibody-dependent cellular phagocytosis (ADCP) of HER2 expressing (>HER2 1+) breast cancer binding T-DXd while cancer cell intrinsic or bystander cytotoxicity of T-DXd will result in the release of neoantigens promoting immune mediated antitumor activity in the tumor microenvironment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
QuantumLeap Healthcare CollaborativeLead Sponsor
5 Previous Clinical Trials
6,923 Total Patients Enrolled
1 Trials studying Breast Cancer
5,000 Patients Enrolled for Breast Cancer
Paula R Pohlmann, MD, MSc, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant history of liver disease, including hepatitis, alcohol abuse, or cirrhosis.You are in a place because of a legal order, such as prison or a mental health facility.I do not have any uncontrolled illnesses or social situations that would affect my study participation.You have had a bad reaction to a medication before.I can take care of myself and perform daily activities.I do not have active or uncontrolled brain or spinal cord cancer.I am 18 years old or older.My recent tests show my organs are working well.I haven't had any cancer treatments recently.I have not had major surgery in the last 4 weeks.I have recovered from previous cancer treatments with minimal side effects.I am willing to use birth control during the study.I am a man or a woman, whether before or after menopause.I have had significant heart problems in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: PRE1 ALX148 (Evorpacept) + Fam-Trastuzumab Deruxtecan-Nxki (T-DXd, Enhertu®)
- Group 2: PRE2 Zanidatamab (ZW25, zani) + Tucatinib (TUKYSA®)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities available for participation in this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov reveals that recruitment for this medical trial, which was initially posted in December 22nd 2022, is currently underway. Approximately 40 patients need to be enrolled from 1 centre of care."
Answered by AI
To what extent are people involved in this experiment?
"Affirmative. Clinical trial data hosted on clinicaltrials.gov reveals that this research study, which was initially listed on December 22nd 2022, is currently enrolling patients. A total of 40 participants are being sought from a single medical facility."
Answered by AI
What deleterious effects have been associated with taking PRE1 ALX148 (Evorpacept) + Fam-Trastuzumab Deruxtecan-Nxki (T-DXd, Enhertu®)?
"There is a dearth of clinical data demonstrating the safety and efficacy of PRE1 ALX148 (Evorpacept) + Fam-Trastuzumab Deruxtecan-Nxki (T-DXd, Enhertu®), leading it to be rated with a score of 1."
Answered by AI
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