Advanced Solid TumorEarly Phase 1NCT05465590
A Phase 1 Study to Evaluate Paclitaxel Conjugated CXC Receptor 4 Antagonist (MB1707) in Patients With Advanced Cancer
A Early Phase 1 study testing MB1707 in people with Advanced Solid Tumor and Breast Cancer, run by Mainline Biosciences, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer
- What is being tested?
- MB1707
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged ≥18 years at the time of informed consent.
- Patients who have previously received at least one line of standard systemic therapy for their advanced/metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment eligible for treatment with a paclitaxel-based regimen.
- Clinical Performance Status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Adequate bone marrow reserves
- Adequate major organ system function
- Female patients must not be pregnant or breastfeeding.
Who cannot join
- Patients with tumor primarily localized to the brainstem or spinal cord. Presence of known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- Patients with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Major surgery within 4 weeks prior to study entry.
- Systemic anticancer therapy within 4 weeks prior to study entry
- Bleeding esophageal or gastric varices <2 months prior to the date of informed consent.
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- History of severe immediate hypersensitivity reaction to paclitaxel
- Active unstable or clinically significant medical condition
- History of any major cardiovascular conditions within the past 6 months
- Patients with known active, uncontrolled bacterial, fungal, or viral infection
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of 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.
Read the detailed description
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.
- Conditions
- Advanced Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer, Ovary Cancer, Pancreatic Neoplasms
- Being tested
- MB1707
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB1707Drug
MB1707 is a CXCR4 antagonist peptide-conjugated paclitaxel.
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.
| Study group | Role | What they receive |
|---|---|---|
| MB1707 Single Dose Phase 1 | Experimental | Phase 1 MB1707 given as a single intravenous (IV) dose of 0.3 mg/kg Receives: Drug: MB1707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 2 days
Time to Cmax (Tmax)
Determine Time of maximum observed MB1707 concentrations (post-dose)
Measured: 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
Measured: 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
Measured: 2 days
Half-life in plasma (t1/2)
Determine Apparent terminal phase half-life of MB1707
Measured: 2 days
Total body clearance (CL)
Determine total body clearance MB1707
Measured: 2 days
Volume of distribution (VZ)
Determine Volume of distribution based on the terminal Phase of MB1707
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startDec 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: The study was terminated due to Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mainline Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Weitzman, MD, Study director, Mainline Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465590
- Sponsor's protocol ID
- MLB-PK-001
- Status last verified
- Dec 2023
- First submitted
- 16 Jul 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of MB1707 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05465590
- Acronym / sponsor ID
- MLB-PK-001
- Conditions
- Advanced Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer, Ovary Cancer, Pancreatic Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated due to Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mainline Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| MB1707 Single Dose Phase 1 | Experimental | Drug: MB1707Phase 1 MB1707 given as a single intravenous (IV) dose of 0.3 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants aged ≥18 years at the time of informed consent.
- Patients who have previously received at least one line of standard systemic therapy for their advanced/metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment eligible for treatment with a paclitaxel-based regimen.
- Clinical Performance Status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Adequate bone marrow reserves
- Adequate major organ system function
Key exclusion criteria (10 listed)
- Patients with tumor primarily localized to the brainstem or spinal cord. Presence of known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- Patients with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Major surgery within 4 weeks prior to study entry.
- Systemic anticancer therapy within 4 weeks prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB1707MB1707 is a CXCR4 antagonist peptide-conjugated paclitaxel. 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. | Drug | MB1707 Single Dose Phase 1 |
Primary outcome
Incidence of Adverse Events (AE) as characterized by type, frequency, severity (NCI CTCAE Version 5.0), timing, seriousness, and relationship to study therapy
Time frame: 14 days
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).
Peak Plasma Concentration (Cmax)
Time frame: 2 days
Determine Maximum observed MB1707 concentration from the time of dosing (0 h) to the time of the last quantifiable MB1707 concentration following dose administration
Time to Cmax (Tmax)
Time frame: 2 days
Determine Time of maximum observed MB1707 concentrations (post-dose)
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: 2 days
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
Area under the concentration-time curve extrapolated to infinity (AUC∞)
Time frame: 2 days
Determine Area under the MB1707 concentration-time curve from the time of dosing (0 h), extrapolated to infinity
Half-life in plasma (t1/2)
Time frame: 2 days
Determine Apparent terminal phase half-life of MB1707
Total body clearance (CL)
Time frame: 2 days
Determine total body clearance MB1707
Volume of distribution (VZ)
Time frame: 2 days
Determine Volume of distribution based on the terminal Phase of MB1707
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Weitzman, MD study director
Mainline Biosciences
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MB1707 in people with Advanced Solid Tumor and Breast Cancer, run by Mainline Biosciences, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AE) as characterized by type, frequency, severity (NCI CTCAE Version 5.0), timing, seriousness, and relationship to study therapy (time frame: 14 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.