Overview

A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of MB1707 in Patients With Advanced Cancer

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mainline Biosciences, Inc.
Criteria
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 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 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