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SHP2 Inhibitor
BBP-398 for Cancer
Phase 1
Waitlist Available
Research Sponsored by Navire Pharma Inc., a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with MAPK-pathway alterations as assessed by clinically validated and/or FDA-approved molecular diagnostic and no available standard of care or curative therapies (MAPK-pathway alterations include, for example KRASG12C mutant, EGFR-mutant)
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 1 dose of bbp-398
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and works well against cancer.
Who is the study for?
Adults over 18 with advanced solid tumors featuring specific MAPK-pathway alterations, like KRASG12C or EGFR mutations, who lack standard treatment options. They must have measurable disease, be in fair to good physical condition (ECOG PS 0-2), and have proper organ function. Participants need to understand and consent to the study's requirements.Check my eligibility
What is being tested?
The trial is testing BBP-398, a new SHP2 inhibitor drug for safety and tolerability. It aims to find the highest dose patients can take without serious side effects (MTD) and determine the recommended dosage for Phase 2 trials (RP2D).See study design
What are the potential side effects?
Specific side effects of BBP-398 are not listed but may include typical reactions seen with cancer treatments such as nausea, fatigue, liver issues, skin rash or other drug-specific reactions based on its mechanism as an SHP2 inhibitor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has MAPK-pathway changes and lacks standard treatment options.
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I am able to get out of my bed or chair and move around.
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My cancer has specific genetic features and I am joining the later phase of the trial.
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My cancer has MAPK-pathway changes and lacks standard treatment options.
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I am able to care for myself and perform daily activities.
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I am over 18 years old and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 1 dose of bbp-398
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 1 dose of bbp-398
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of Maximum Tolerated Dose (MTD) and establish the RP2D of BBP-398.
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) of BBP-398
Determination of anti-tumor activity of BBP-398
Maximum observed plasma concentration (Cmax) of BBP-398
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Oral capsules administered at MTD/RP2D defined dose. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
Cohort A: Advanced or metastatic KRAS mutant solid tumor
Cohort B: Advanced solid tumor with NF1 loss-of-function (LOF) or metastatic BRAF class II/III mutant solid tumor
Group II: Dose EscalationExperimental Treatment1 Intervention
Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
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Who is running the clinical trial?
Navire Pharma Inc., a BridgeBio companyLead Sponsor
2 Previous Clinical Trials
130 Total Patients Enrolled
Carl Dambkowski, MD, VP Clinical Strategy, MDStudy ChairNavire Pharma Inc., a BridgeBio company
Lauren Wood, MDStudy DirectorNavire Pharma Inc., a BridgeBio company
2 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and not pregnant.I have active brain metastases or carcinomatous meningitis.My cancer has MAPK-pathway changes and lacks standard treatment options.I am able to get out of my bed or chair and move around.I have another cancer that is getting worse or needs treatment.My organs are functioning well.My cancer has specific genetic features and I am joining the later phase of the trial.I am willing and able to follow the study's schedule and procedures.My cancer has MAPK-pathway changes and lacks standard treatment options.I have a serious heart condition.My tumor has a known activating mutation.I am able to care for myself and perform daily activities.I have a known tumor in my brain or spinal cord.I have been treated with a SHP2 inhibitor before.I can understand and am willing to sign the consent form for the study.My cancer has specific genetic features for the study.My organs are functioning well.I am over 18 years old and not pregnant.I cannot swallow pills or have a stomach condition that affects medication absorption.I am currently on dialysis.I have an active Hepatitis B, Hepatitis C, or HIV infection.I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.I can understand and am willing to sign the consent form for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion
- Group 2: Dose Escalation
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.
How hazardous is BBP-398 (Formerly Known as IACS-15509) to human health?
"As this is a Phase 1 trial, our team at Power assigned BBP-398 (formerly IACS-15509) a score of 1 due to the limited data currently available on its safety and efficacy."
Answered by AI
Can I still submit my information to be part of this experiment?
"Affirmative. According to the data available on clinicaltrials.gov, this medical research project was initiated on November 12th 2020 and is now actively recruiting participants. 130 individuals are needed across 6 different sites for enrolment in this trial."
Answered by AI
What proportion of Canadian health facilities are currently undertaking this clinical experiment?
"6 distinct clinical trial sites are participating in this study. These include UCLA Hematology/Oncology - Santa Monica, The University of Texas MD Anderson Cancer Center and Huntsman Cancer Institute as well as 3 other medical centres."
Answered by AI
What is the current sampling size of this clinical experiment?
"According to the study's criteria, 130 qualified candidates are needed for enrollment. Potential participants can find participating sites in Santa Monica, California and Houston, Utah; UCLA Hematology/Oncology - Santa Monica and The University of Texas MD Anderson Cancer Center respectively."
Answered by AI
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