Actively Recruiting
Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors
Led by Mainline Biosciences (Shanghai) Co., Ltd · Updated on 2025-12-02
156
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, single-arm, dose-escalation and dose-expansion Phase I/II study to evaluate the safety, tolerability and preliminary anti-tumor activity of MB0151 in adult subjects (at least 18 years old) with advanced solid tumors. This study includes two phases: dose escalation and dose expansion. In this study, the protocol of accelerated titration combined with i3+3 is used for dose escalation,administered intravenously every 2 weeks. Enrolled subjects will be sequentially assigned to the planned dose cohorts according to this protocol to receive MB0151 treatment and will be monitored for the occurrence of DLT. The RP2D and/or OBD will be determined by considering the PK profile, safety and efficacy data in the dose-escalation stage (including backfill cohorts).
CONDITIONS
Official Title
Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged over 18 years
- Histologically or cytologically confirmed solid tumor including advanced small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, triple negative breast cancer, or other advanced solid tumors with progression or intolerance to standard treatments
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Normal organ function defined by specific blood counts, liver, kidney, and coagulation parameters
- Provision of archived or fresh tumor tissue samples for biomarker testing within 2 years
- At least one measurable target lesion by RECIST version 1.1 criteria
- Females must not be pregnant or breastfeeding and agree to use effective contraception during the study; males must agree to use contraception
- Ability to understand and sign informed consent form
You will not qualify if you...
- Serious or poorly controlled systemic diseases, active bleeding, renal or liver transplantation, active infections including HIV, hepatitis B or C
- Other malignancies within 3 years except certain treated cancers such as stage 1B cervical cancer or non-invasive skin cancers
- Specific cardiac conditions including severe angina, recent heart attack or stroke, heart failure, abnormal QTc interval, or poorly controlled hypertension
- Major surgery within 28 days prior to first dose
- Unstable or symptomatic brain metastases or central nervous system involvement requiring treatment
- Life-threatening trauma or severe head injury within 2 months
- Tumors invading major blood vessels with bleeding risk
- Peripheral neuropathy Grade 2 or higher
- Active significant infections requiring recent antibiotic treatment
- Inflammatory bowel disease or significant lung diseases including severe asthma or COPD
- Acute or chronic inflammatory skin diseases not recovered
- Recent history of serious venous thromboembolism
- Effusions requiring intervention unless stable
- History of immunodeficiency disorders
- Active ocular surface diseases or history of cicatricial conjunctivitis
- Recent systemic anti-tumor treatments or radiotherapy within specified washout periods
- Use of strong CYP3A inhibitors or inducers within 2 weeks
- Vaccination with live attenuated vaccines within 4 weeks prior
- High dose corticosteroid use within 2 weeks
- Previous treatment with orestatin derivatives
- Unresolved adverse events from prior anti-cancer treatments except specified conditions
- Participation in concurrent interventional clinical trials
- Known bleeding risk from coagulation defects
- Unhealed major hemorrhage within 14 days
- Allergies to octreotide, somatostatin analogues, study drug or derivatives
- Any other condition judged by the investigator to pose excessive risk or affect participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinming Yu, Doctor of Medicine
CONTACT
Y
Yuping Sun, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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