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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 through study completion, approximately 1 year
Awards & highlights
Summary
This trial studies a new oral medicine to treat certain advanced and metastatic cancers in adults. It looks at how safe and effective the medicine is.
Who is the study for?
Adults with recurrent advanced/metastatic cancers that have specific mutations in the BRAF, KRAS (excluding G12C), or NRAS genes. This includes certain types of lung cancer, melanoma, thyroid cancer, colorectal cancer and other solid tumors. Participants must have tried standard treatments without success and should not be pregnant or breastfeeding.Check my eligibility
What is being tested?
BDTX-4933 is being tested for its safety and effectiveness against various cancers with specific genetic mutations. Patients will take this oral medication in cycles of 28 days to see if it can control their cancer growth.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to anticancer medications such as nausea, fatigue, blood count changes, liver function alterations and possibly others depending on individual patient factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation: Incidence of dose-limiting toxicities (DLTs) to estimate the preliminary RP2D and/or MTD of BDTX-4933
Dose Expansion: Duration of response (DOR)
Dose Expansion: Objective response rate (ORR) including extracranial and intracranial
+2 moreSecondary outcome measures
Dose Escalation/Expansion: Area under the plasma drug concentration-time curve (AUC) of BDTX-4933 and its metabolite
Dose Escalation/Expansion: Half-life (t1/2) of BDTX-4933 and its metabolite
Dose Escalation/Expansion: Incidence and severity of treatment-emergent adverse events (TEAEs)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1 Dose ExpansionExperimental Treatment1 Intervention
BDTX-4933 will be administered at the RP2D.
Group II: Phase 1 Dose EscalationExperimental Treatment1 Intervention
BDTX-4933 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached and the preliminary recommended Phase 2 dose (RP2D) is determined.
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Who is running the clinical trial?
Black Diamond Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
291 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced, cannot be surgically removed, and has RAS or BRAF mutations.My brain metastases are stable and I don't need more steroids for them.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation
- Group 2: Phase 1 Dose Expansion
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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