BP1001-A in Patients With Advanced or Recurrent Solid Tumors

Part of paid clinical trials in Silver Spring, Maryland.

Sponsor
Bio-Path Holdings, Inc.
Study ID
NCT04196257
Phase
PHASE1
Status
Recruiting
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Conditions

  • Carcinoma, Ovarian Epithelial
  • Endometrial Cancer
  • Fallopian Tube Neoplasms
  • Peritoneal Cancer
  • Solid Tumor
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) — DRUG
    Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.
  • BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 19, 2022
Status verified
Mar 2025
Primary completion
Jul 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BP1001-A monotherapy
    Dose escalation of BP1001-A monotherapy
  • Experimental: BP1001-A and Paclitaxel
    Dose expansion of selected dose of BP1001-A with paclitaxel

Primary Outcome Measure

Identify Dose Limiting Toxicity (DLT) of BP1001-A [ Time Frame: 30 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Holy Cross HospitalSilver SpringMaryland20910
Sujana Lalagari
[email protected]
571-226-0078
James Barter, MD
[email protected]
James Barter, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Entela Rama
[email protected]
313-576-9447
Victoria LaBush, CCRP
[email protected]
313-576-8411
Ira Winer, MD (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230
Joshua Matson
[email protected]
214-545-3933
Minal Barve, M.D. (PRINCIPAL_INVESTIGATOR)
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Shannon Westin, M.D., M.P.H.
713-794-4314
Shannon Westin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Silver Spring, MD

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By research site
Holy Cross Hospital· Silver Spring, MDKarmanos Cancer Institute· Detroit, MIMary Crowley Cancer Research· Dallas, TXThe University of Texas M.D. Anderson Cancer Center· Houston, TX

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