Actively Recruiting
A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBB0979 in Patients With Locally Advanced or Metastatic Solid Tumors
Led by SUNHO（China）BioPharmaceutical CO., Ltd. · Updated on 2025-01-17
25
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IBB0979 in a Phase 1/2 open-label study involving patients with locally advanced or metastatic solid tumors who have previously received treatment. The study aims to understand the safety, tolerability, pharmacokinetics, immune response, and early signs of antitumor activity of IBB0979. This investigational drug is being studied in patients whose tumors have progressed after standard therapies or for whom no standard treatment exists. The study includes three phases: Dose Escalation, Dose Expansion, and Clinical Exploration. In the Dose Escalation Phase, patients receive increasing doses of IBB0979, administered by subcutaneous injection, following a 3+3 design to determine safe dose levels. The Dose Expansion Phase enrolls patients to receive the established maximum tolerated dose in 21-day treatment cycles until withdrawal or discontinuation. After these phases, investigators and sponsors will discuss further exploration based on the collected safety and efficacy data. Participants will undergo regular assessments including monitoring for adverse events, dose-limiting toxicities, and response to treatment using tumor measurements. Pharmacokinetic samples will be collected at multiple time points during each 21-day cycle, and immunogenicity will be evaluated. The main outcomes include safety events and objective tumor response rates over up to two years. The total study duration varies by participant, with follow-up extending to monitor long-term effects and survival.
CONDITIONS
Brief Title
A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 to 80 years old
- Histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors
- Failed prior standard therapy, no standard therapy exists, or standard therapy not appropriate
- At least one assessable tumor lesion in Dose Escalation Phase and one measurable lesion in Dose Expansion Phase per RECIST 1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ functions including hematologic, liver, renal, and thrombin function
- Agree to use reliable contraception during and for 90 days after treatment if of reproductive potential
- Negative pregnancy test within 7 days prior to treatment for females of childbearing potential
- Ability to provide informed consent prior to any study procedures
You will not qualify if you...
- Known severe hypersensitivity to recombinant proteins or drug components
- Recent anti-tumor therapy within specified timeframes before treatment start
- Use of unapproved investigational products within 4 weeks prior to treatment
- Major organ surgery or significant trauma within 4 weeks prior to treatment
- Recent systemic corticosteroids or immune-suppressive drugs within 14 days prior to treatment
- Recent immunomodulatory agents or live virus vaccination within defined periods
- Prior allogeneic stem-cell or solid organ transplantation
- Unresolved adverse effects from prior anti-tumor therapy above Grade 1
- Active brain or leptomeningeal metastases with symptoms, except treated stable brain metastases
- Active infection requiring IV antibiotics
- Active hepatitis B or C infection beyond defined thresholds
- Current interstitial lung disease (except stable radiation fibrosis)
- Severe cardiovascular or cerebrovascular diseases per specified criteria
- Active or suspected autoimmune diseases except stable specified conditions
- History of severe immune-related adverse events from immunotherapy
- History or concurrent other malignancies with exceptions for certain disease-free durations
- Clinically uncontrolled fluid buildup unsuitable for study participation
- Known alcohol or drug dependence
- History of mental disorder or poor adherence
- Pregnancy or breastfeeding
- Other severe systemic diseases or conditions contraindicating participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several 21-day cycles until maximum tolerated dose is determined
Participants begin the Dose Escalation Phase where safety and tolerability of IBB0979 are initially assessed with dose escalation.
Multiple visits during each 21-day treatment cycle with frequent assessments
Duration - Repeated 21-day cycles until withdrawal or treatment discontinuation
Participants receive IBB0979 at the established maximum tolerated dose in the Dose Expansion Phase. Treatment continues until withdrawal or discontinuation.
Repeated weekly visits for treatment and assessments every 21 days
Duration - Duration based on study design post phase I, variable
Participants may enter the Clinical Exploration Phase where treatment and study procedures are based on prior phase results and discussions with the sponsor.
Visit schedule determined per investigational plan
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
Research Team
J
jianxiang cao, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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