Not yet recruiting NCT07136142
A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FH-006 for Injection.
- Who it may be relevant to
- Registry conditions: Malignant Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors
Overview
This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.
Interventions
- Drug FH-006 for Injection
FH-006 for injection.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: Assessed up to 6 months.]
Secondary outcome measures (6)
- Time to maximum concentration (Tmax) [Time frame: Up to 2 years.]
- Maximum concentration (Cmax) [Time frame: Up to 2 years.]
- Terminal half-life (t1/2) [Time frame: Up to 2 years.]
- Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t) [Time frame: Up to 2 years.]
- Adverse events (AEs) [Time frame: Up to 24 weeks.]
- Serious adverse events (SAEs) [Time frame: Up to 24 weeks.]
Eligibility criteria
Inclusion criteria
- Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.
- Patients with unresectable recurrent or metastatic solid tumors.
- There is at least one lesion that could be measured.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Adequate organ functions as defined.
- Life expectancy ≥ 3 months.
Exclusion criteria
- Patients with known active central nervous system (CNS) metastases.
- Subjects who had other malignancy in five years before the first dose.
- Patients with tumor-related pain that can not be controlled as determined.
- Patients with serious cardiovascular and cerebrovascular diseases.
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
- Patients with severe infections.
- History of immunodeficiency.
- History of autoimmune diseases.
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy.
- Active infection.
- Pregnant or nursing women.
- Known history of serious allergic reactions to the investigational product or its main ingredients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Fudan University Shanghai Cancer Center — Shanghai
- Tianjin Medical Unversity Cancer Institute & Hospital — Tianjin
Identifiers
NCT: NCT07136142 · FH-006-102