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2022-12
2024-11
2024-12
0
NCT05465590
Mainline Biosciences, Inc.
Mainline Biosciences, Inc.
INTERVENTIONAL
A Phase 1 Study to Evaluate Paclitaxel Conjugated CXC Receptor 4 Antagonist (MB1707) in Patients With Advanced Cancer
The study will evaluate the pharmacokinetics (PK) and safety of a single intravenous (IV) dose of 0.3 mg/kg MB1707 in patients with advanced cancers.
MB1707, paclitaxel (PTX) conjugated CXC chemokine receptor 4 (CXCR4) peptide antagonist, a peptide-drug conjugate (PDC), for the treatment of cancer. MB1707 is a potent CXCR4 antagonist which inhibits tumor growth and metastasis by blocking the stromal cell derived factor 1 (SDF-1, a.k.a. CXCL12)/CXCR4 signaling pathway. MB1707 contains a conjugated drug, paclitaxel. By specific binding to CXCR4 overexpressed by the tumor cells, MB1707 has a built-in targeted delivery mechanism. The study will evaluate the PK and safety of a single intravenous (IV) dose of 0.3 mg/kg MB1707 in patients with advanced cancers. Up to 6 patients will be enrolled. Patients will be treated with a single intravenous (IV) dose of MB1707 over 3 hours on Day 1 only. Patients will be pre-medicated with an antihistamine (eg, diphenhydramine), a corticosteroid (e.g., dexamethasone), and a H2 receptor antagonist (e.g., famotidine), within 30 to 60 minutes prior to infusion at doses per institutional guidelines. Patients will be observed for 60 minutes after Cycle 1 dose administration. Patients will complete a 14-day Safety Follow-up Visit following the single dose.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-07-16 | N/A | 2023-12-16 |
2022-07-16 | N/A | 2023-12-21 |
2022-07-20 | N/A | 2023-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MB1707 Single Dose Phase 1 Phase 1 MB1707 given as a single intravenous (IV) dose of 0.3 mg/kg | DRUG: MB1707
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AE) as characterized by type, frequency, severity (NCI CTCAE Version 5.0), timing, seriousness, and relationship to study therapy | Treatment-emergent AEs through 14 days after last protocol therapy will be summarized by Medical Dictionary for Regulatory Activities (MedDRA) Version 14.0 (or higher) System Organ Class and preferred term. The incidences and percentages of participants experiencing each AE preferred term will be summarized with descriptive statistics. AEs will also be summarized by NCI CTCAE, Version 5.0, by grade and by causality (attribution to study treatment). | 14 days |
| Peak Plasma Concentration (Cmax) | Determine Maximum observed MB1707 concentration from the time of dosing (0 h) to the time of the last quantifiable MB1707 concentration following dose administration | 2 days |
| Time to Cmax (Tmax) | Determine Time of maximum observed MB1707 concentrations (post-dose) | 2 days |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) | Determine Area under the MB1707 concentration-time curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration | 2 days |
| Area under the concentration-time curve extrapolated to infinity (AUC∞) | Determine Area under the MB1707 concentration-time curve from the time of dosing (0 h), extrapolated to infinity | 2 days |
| Half-life in plasma (t1/2) | Determine Apparent terminal phase half-life of MB1707 | 2 days |
| Total body clearance (CL) | Determine total body clearance MB1707 | 2 days |
| Volume of distribution (VZ) | Determine Volume of distribution based on the terminal Phase of MB1707 | 2 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
