BDTX-4933 for Cancer

Recruiting at 15 trial locations

Overseen By BDTX Clinical Trial Navigation Service

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Black Diamond Therapeutics, Inc.

Must not be taking: Anticancer, Radiation, Experimental agents

Disqualifiers: MEK1/2 mutation, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

BDTX-4933-101 is a first-in-human, open-label, Phase 1 dose escalation and an expansion cohort study designed to evaluate the safety and tolerability, maximum tolerated dose (MTD) and the preliminary recommended Phase 2 dose (RP2D), and antitumor activity of BDTX-4933. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC) harboring KRAS non-G12C mutations, BRAF, or CRAF (RAF1) mutations, advanced/metastatic melanoma harboring BRAF or NRAS mutations, histiocytic neoplasms harboring BRAF, CRAF, or NRAS mutations, and other solid tumors harboring BRAF mutations. The study population for the Dose Expansion part of the study comprises adults with recurrent advanced/metastatic NSCLC harboring KRAS non-G12C mutations. All patients will self-administer BDTX-4933 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, ongoing anticancer therapy and radiation therapy are not allowed during the study.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and has RAS or BRAF mutations.

Specific criteria for Dose Escalation cohorts: NSCLC with KRAS non-G12C mutations, Melanoma with BRAF or NRAS mutations, Histiocytic neoplasms with BRAF or NRAS mutations, Thyroid carcinoma with BRAF mutations, Colorectal carcinoma with BRAF mutations, Other solid tumors with BRAF mutations after prior treatment with a BRAF/MEK inhibitor, Specific criteria for Dose Expansion cohort: Recurrent advanced/metastatic NSCLC with KRAS non-G12C mutations without small cell lung cancer transformation with progressive disease confirmed by radiographic assessment

My brain metastases are stable and I don't need more steroids for them.

Exclusion Criteria

Cancer with a known MEK1/2 mutation, Major surgery within 4 weeks of study entry or planned during study, Ongoing anticancer therapy, Ongoing radiation therapy, Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy, Symptomatic spinal cord compression, Evidence of active malignancy requiring systemic therapy within the next 2 years, History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO, Females who are pregnant or breastfeeding, Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study, Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

BDTX-4933 is administered at escalating dose levels to determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D)

28-day cycles

Cycle 1 includes monitoring for dose-limiting toxicities

Dose Expansion

BDTX-4933 is administered at the RP2D to further evaluate safety and antitumor activity

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BDTX-4933

Trial Overview 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.

Participant Groups

Group I: Phase 1 Dose Expansion Experimental Treatment 1 Intervention

BDTX-4933 will be administered at the RP2D.

Group II: Phase 1 Dose Escalation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Black Diamond Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

390+