Clinical trial · Interventional
A Phase 1 Study to Evaluate Paclitaxel Conjugated CXC Receptor 4 Antagonist (MB1707) in Patients With Advanced Cancer
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of MB1707 in Patients With Advanced Cancer
NCT05465590CI-TRIAL-00072479withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to Sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovary Cancer | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MB1707 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MB1707 Single Dose Phase 1
- description
- Phase 1 MB1707 given as a single intravenous (IV) dose of 0.3 mg/kg
- interventionNames
- Drug: MB1707
Primary outcomes (8)
- measure
- Incidence of Adverse Events (AE) as characterized by type, frequency, severity (NCI CTCAE Version 5.0), timing, seriousness, and relationship to study therapy
- timeFrame
- 14 days
- description
- 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).
- measure
- Peak Plasma Concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female participants aged ≥18 years at the time of informed consent. 2. 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. 3. Clinical Performance Status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 4. Adequate bone marrow reserves 5. Adequate major organ system function 6. Female patients must not be pregnant or breastfeeding. Exclusion Criteria: 1. 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. 2. 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). 3. 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. 4. Major surgery within 4 weeks prior to study entry. 5. Systemic anticancer therapy within 4 weeks prior to study entry 6. Bleeding esophageal or gastric varices \<2 months prior to the date of informed consent. 7. History of severe immediate hypersensitivity reaction to paclitaxel 8. Active unstable or clinically significant medical condition 9. History of any major cardiovascular conditions within the past 6 months 10. Patients with known active, uncontrolled bacterial, fungal, or viral infection
References
Publications (0)
Data not yet available
No reference posted for this study.