A Phase 1a/b Non-Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile Compound 31510 (Ubidecarenone, USP) Nanosuspension for Injection Administered Intravenously to Patients with Solid Tumors

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women who have cancer with advanced solid tumors who are not responding to standard therapy, or for whom there is no standard therapy available.

The study is evaluating an experimental drug called BPM31510. In laboratory experiments on animals, BPM31510 had an effect on some of the chemical reactions in cancer cells that cause the cells to die and the tumors to shrink.

In a previous study, participants received BPM31510 given as a 4-hour or a 24-hour infusion 3 times a week. The purpose of this study is to evaluate the safety of BPM31510 when given as a 48-hour infusion twice a week by itself, and in combination with a commonly used chemotherapy (such as gemcitabine, 5-FU, or docetaxel). The study will also evaluate how BPM31510 affects the cancer tumor and how much of the drug leaves a participants body over a period of time.

The study has two parts, Arm 1 and Arm 2.

Arm 1:
Arm 1 will help determine the highest dose of BMO3150 that can be given without causing serious side effects. Participants will receive different doses of BMO3150 by itself. In Arm 1, treatment cycles are 28 days. Participants may receive up to 12 cycles (48 weeks) of BPM31510 therapy. Participants who do not have serious side effects but whose tumor has grown may be able to receive BPM31510 combined with standard chemotherapy. 
Arm 2:
Participants in Arm 2 will receive BPM31510 and standard chemotherapy treatment for up to 12 treatment cycles (28-day cycles).
Participants in both parts of the study may be able to continue treatment after the study ends if the physician thinks it is appropriate. 

Disease Status and/or Stage

Advanced Solid Tumors

Sponsor

Berg Pharma

Key Eligibility

  • Men and women age 18 and older
  • Solid tumor cancer that is metastatic or unresectable (cannot be removed by surgery) and for which standard treatment is not available or effective
  • Primary brain cancer or lymphoma is included in eligibility
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Manish Shah, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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