BDTX-4933 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Black Diamond Therapeutics, Inc.

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 the first 28-day cycle (cycle 1)

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ the first 28-day cycle (cycle 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the first 28-day cycle (cycle 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and the first 28-day cycle (cycle 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation: Incidence of dose-limiting toxicities (DLTs) to estimate the preliminary RP2D and/or MTD of BDTX-4933

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Do I qualify?Apply below to find out