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Checkpoint Inhibitor
CHK1 Inhibitor for Lung Cancer (POTENTIATE Trial)
Phase 1
Recruiting
Research Sponsored by Boundless Bio
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 start of cycle 1 until 30 days following last dose (each cycle is 28 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial is researching a potential new cancer treatment to see how safe and effective it is.
Who is the study for?
This trial is for adults with advanced solid tumors like lung, stomach, or breast cancer that's worsened after standard treatments. Participants must have evidence of oncogene amplification and measurable disease. They should be in good physical condition (ECOG PS 0 or 1) and have proper organ function. People with primary brain cancers, certain heart conditions, active hepatitis B/C or HIV, a history of severe lung issues, or those who've had specific transplants can't join.
What is being tested?
The study tests BBI-355 as a new treatment targeting ecDNA in tumors. It's an early-phase trial to find the safest dose when given alone or with other therapies. The drug is taken orally and aims to inhibit CHK1—a protein involved in tumor cell growth.
What are the potential side effects?
As this is a first-in-human study for BBI-355, detailed side effects are not yet known but may include typical reactions related to checkpoint inhibitors such as fatigue, nausea, blood count changes and potential liver or kidney function alterations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of cycle 1 until 30 days following last dose (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of cycle 1 until 30 days following last dose (each cycle is 28 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355 as a single agent and in combination with each of the following agents: erlotinib or futibatinib
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-355 as a single agent and in combination with either erlotinib or futibatinib
Secondary study objectives
Anti-tumor activity of BBI-355 as a single agent and in combination with either erlotinib or futibatinib
Area under the concentration time curve (AUC) of BBI-355, erlotinib, and futibatinib
Maximum observed plasma concentration (Cmax) of BBI-355, erlotinib, and futibatinib
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Single Agent Dose ExpansionExperimental Treatment1 Intervention
Single agent BBI-355, administered orally in 28-day cycles
Group II: Single Agent Dose EscalationExperimental Treatment1 Intervention
Single agent BBI-355, administered orally in 28-day cycles
Group III: Dose Escalation in Combination with FGFR InhibitorExperimental Treatment2 Interventions
Combination therapy of BBI-355 and FGFR1-4 inhibitor futibatinib, administered orally in 28-day cycles.
Group IV: Dose Escalation in Combination with EGFR InhibitorExperimental Treatment2 Interventions
Combination therapy of BBI-355 and EGFR inhibitor erlotinib, administered orally in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib
2011
Completed Phase 4
~2290
Futibatinib
2014
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Boundless BioLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Klaus Wagner, MD, PhDStudy DirectorBoundless Bio
2 Previous Clinical Trials
191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it fits the study's exceptions.My cancer has specific gene changes known to help it grow.I have a history of hepatitis B, hepatitis C, or HIV.I have a serious heart condition.I have or had lung inflammation or scarring that needed strong medication.I have had an organ or bone marrow transplant.My cancer has spread, doesn't respond to treatment, and can't be surgically removed.My cancer shows gene changes that make it grow faster.My cancer shows a high level of normal EGFR.My cancer shows a high level of FGFR1-4 without mutations.I am fully active or restricted in physically strenuous activity but can do light work.My blood counts are within a healthy range.My liver and kidneys are working well.I do not have active brain cancer or symptoms from cancer spread to my brain, with some exceptions.I have previously been treated with EGFR inhibitors.I have a blood cancer.I have previously been treated with CHK1 inhibitors.I have previously been treated with FGFR inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Single Agent Dose Escalation
- Group 2: Single Agent Dose Expansion
- Group 3: Dose Escalation in Combination with EGFR Inhibitor
- Group 4: Dose Escalation in Combination with FGFR Inhibitor
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.
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