Actively Recruiting
Study of MHB088C for Patients With Advanced Solid Malignant Tumors
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-08-03
515
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety/tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors
CONDITIONS
Official Title
Study of MHB088C for Patients With Advanced Solid Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to follow the treatment and visit plans, and sign informed consent
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival of at least 3 months
- Participants of childbearing potential agree to use reliable contraception during the study and for at least 90 days after last dose
- Female participants of childbearing potential must have a negative blood pregnancy test before first dose and must not be breastfeeding
- Able and willing to comply with study procedures and follow-up
- Phase Ia: Confirmed unresectable advanced or metastatic malignant solid tumors progressed or intolerant to standard care or no standard care available
- Phase Ib: Confirmed unresectable advanced or metastatic malignant solid tumors relapsed or progressed after systemic treatment or no standard care available
- Phase II: Confirmed unresectable advanced or metastatic small cell lung cancer progressed during or after platinum-based chemotherapy and immune checkpoint inhibitors
You will not qualify if you...
- More than two primary malignancies before signing consent
- Received anti-tumor treatment or traditional Chinese medicine before first dose of investigational drug
- Received other unmarketed investigational drugs or therapies before first dose
- Unstable brain metastases or leptomeningeal carcinomatosis
- Unresolved adverse reactions from previous anti-tumor treatments worse than Grade 1 CTCAE 5.0
- Major organ surgery or significant trauma before first dose or needing elective surgery during the study
- Vaccinated with live attenuated vaccines before first dose
- Mucosal or internal bleeding for non-traumatic reasons before first dose
- Treatment with systemic corticosteroids or immunosuppressive agents before first dose
- Severe pulmonary disease impacting lung function
- History or current non-infectious interstitial lung disease or pneumonitis requiring steroids or suspected but not excluded by imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lin Shen, Ph.D
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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