Trials / Recruiting
RecruitingNCT04196257
BP1001-A in Patients With Advanced or Recurrent Solid Tumors
A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Bio-Path Holdings, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.
Conditions
- Solid Tumor, Adult
- Carcinoma, Ovarian Epithelial
- Fallopian Tube Neoplasms
- Endometrial Cancer
- Peritoneal Cancer
- Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) | Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles. |
| DRUG | BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel | Dose expansion of BP1001-A IV twice weekly (Maximum tolerated dose or Maximum admistered dose) plus paclitaxel IV weekly for 4 weeks (28-day cycle) for 6 cycles. |
Timeline
- Start date
- 2022-08-19
- Primary completion
- 2027-07-01
- Completion
- 2027-10-01
- First posted
- 2019-12-12
- Last updated
- 2025-03-07
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04196257. Inclusion in this directory is not an endorsement.