Study Summary
This trial is testing a new drug, ABM-1310, to see if it is safe and effective in treating cancer. The trial will have two parts, testing the drug alone and in combination with another drug, cobimetinib. The trial will use a "3+3" design to determine the maximum tolerated dose and the recommended Phase 2 dose.
- BRAF V600E Mutation
- Advanced Solid Tumors
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: Up to study discontinuation (an average of 1 year)
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
6 Treatment Groups
Monotherapy Therapy Dose Expansion-1
1 of 6
Monotherapy Therapy Dose Expansion-2
1 of 6
Combination Therapy Dose Expansion-1
1 of 6
Combination Therapy Dose Expansion-2
1 of 6
Monotherapy Dose Escalation
1 of 6
Combination Therapy Dose Escalation
1 of 6
Experimental Treatment
112 Total Participants · 6 Treatment Groups
Primary Treatment: Monotherapy Therapy Dose Expansion-1 · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are there any prior investigations that focused on Monotherapy Dose Escalation?
"Monotherapy Dose Escalation was first investigated in 2013 at Local Institution - 0046. Subsequent to this, 30 trials have been fully completed and 54 are currently ongoing across the region of San Francisco, California." - Anonymous Online Contributor
Is this research a pioneering endeavor?
"Monotherapy Dose Escalation began clinical trials in 2013, sponsored by Bristol-Myers Squibb. Following the first study involving 1163 participants, this medication was approved for Phases 1 & 2 of drug development and is now being trialled on 54 different sites across 352 cities and 48 countries globally." - Anonymous Online Contributor
What is the scope of this trial's implementation across medical centers?
"The trial is administrated from University of California- San Francisco in San Francisco, Stanford University School of Medicine in Stanford and Henry Ford Cancer Institute located in Detroit. Additionally, there are 5 other clinical sites providing services for this study." - Anonymous Online Contributor
Are there any available slots for participation in this experiment?
"Clinicaltrials.gov confirms that recruitment for this study is ongoing, with the experiment originally posted in June 2020 and updated as recently as September 2022." - Anonymous Online Contributor
What is the sample size of this medical experiment?
"Yes, the clinicaltrials.gov website confirms that enrollment for this medical experiment is currently underway; it was originally posted on June 16th of 2020 and recently modified on September 16th of 2022. The research requires 48 participants to be recruited from a total of 5 sites." - Anonymous Online Contributor
What is the regulatory status of Monotherapy Dose Escalation?
"Our experts at Power assigned a score of 1 for the safety assessment of monotherapy dose escalation, as this is an early-stage trial with limited data to support both effectiveness and security." - Anonymous Online Contributor