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Phase 1 Dose Escalation for Skin Cancer

Site 1003 NEXT Virginia, Fairfax, VA
Skin Cancer+31 More ConditionsBDTX-4933 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Skin Cancer
  • BRAF Gene Mutation
  • BRAF V600E Mutation
  • Metastatic Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Lung Cancer
  • Recurrent Melanoma
  • Non-Small Cell Lung Cancer
  • Solid Cancer
  • KRAS G12V Mutation
  • Neurofibromatosis Type 1 (NF1)
  • Histiocytic and Dendritic Cell Neoplasm
  • Metastatic Brain Tumors
  • Thyroid Cancer
  • Recurrent Lung Cancer
  • Non-Small Cell Lung Cancer, Recurrent
  • Non-Small Cell Carcinoma
  • Solid Tumors
  • Histiocytosis
  • Histiocytic Neoplasm
  • Melanoma
  • B-Raf Mutation-Related Tumors
  • Metastatic Melanoma
  • KRAS G12D Mutation
  • KRAS Mutation-Related Tumors
  • Colorectal Cancer
  • Brain Tumor

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Through study completion, approximately 1 year

Year 1
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: Maximum plasma concentration (Cmax) of BDTX-4933 and its metabolite
Dose Escalation/Expansion: Time of maximum plasma concentration (Tmax) of BDTX-4933 and its metabolite
Year 1
Dose Escalation/Expansion: Duration of response (DOR)
Dose Escalation/Expansion: Objective response rate (ORR) including extracranial and intracranial
Dose Escalation/Expansion: Progression-free survival (PFS)
Dose Escalation/Expansion: Time to response
During the dose-limiting toxicity period (first 28-day cycle)
Dose Escalation: Safety and tolerability of BDTX-4933 to determine the RP2D(s) or MTD if RP2D(s) cannot be determined.
Month 12
Dose Escalation/Expansion: Overall survival
The first 28-day cycle (Cycle 1)
Dose Escalation: Incidence of dose-limiting toxicities (DLTs) to estimate the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of BDTX-4933
Year 1
Dose Escalation/Expansion: Incidence and severity of treatment-emergent adverse events (TEAEs)

Trial Safety

Phase-Based Safety

1 of 3

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1
Dose Escalation - HFB200603 in combination with tislelizumab
1
Expansion Phase
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Phase 1 Dose Escalation
1 of 2
Phase 1 Dose Expansion
1 of 2

Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: Phase 1 Dose Escalation · No Placebo Group · Phase 1

Phase 1 Dose Escalation
Drug
Experimental Group · 1 Intervention: BDTX-4933 · Intervention Types: Drug
Phase 1 Dose Expansion
Drug
Experimental Group · 1 Intervention: BDTX-4933 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, approximately 1 year

Who is running the clinical trial?

Black Diamond Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
211 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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References

Frequently Asked Questions

Does this clinical trial currently admit participants?

"Affirmative. According to the clinicaltrials.gov database, this therapeutic trial is currently recruiting participants and was first made public on April 18th 2023. The study requires 140 people from two separate medical sites with an update having been posted as recently as April 24th 2023." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Phase 1 Dose Expansion?

"Due to the limited data collected during Phase 1 trials, our team at Power assigned a score of 1 for Dose Expansion's safety and effectiveness." - Anonymous Online Contributor

Unverified Answer

What is the highest capacity of participants in this medical experiment?

"Affirmative. Clinicaltrials.gov lists this trial as actively recruiting, beginning April 18th 2023 and edited last on the 24th of that same month. 140 individuals will be accepted between two distinct sites for this study's duration." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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