Advanced Solid Tumor
Conditions
Keywords
Advanced Solid Tumor
Brief summary
This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors
Detailed description
Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.
Interventions
DRUGIBI 360 Injection
IBI 360 dose level of escalation IV Q3W Day 1
DRUGIBI 360 Injection Sintilimab
IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provide signed informed consent; 2. Male or female aged at 18-75 (inclusive) years; 3. Expected survival ≥12 weeks; 4. ECOG PS score 0 or 1; 5. Provide archival or fresh tissues for CLDN18.2 expression analysis; 6. Adequate laboratory parameters; 7. Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows: Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments. Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors
Exclusion criteria
1. The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART; 2. The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug; 3. Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment; 4. The subjects with history of hypersensitivity to the study drug; 5. The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment; 6. The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis; 7. The subjects with pyloric obstruction; 8. The subjects with active or poorly controlled serious infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerance | up to 90 days following last dose | Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0) |
| Recommended Phase 2 Dose (RP2D) | up to 21 days following last dose level | A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | Subjects were randomized 6 months and 1 year later | Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1). |
| Pharmacokinetics | Up to 48 weeks following first dose | Area under plasma concentration vs time curve(AUC) |
| Immunogenicity | up to 90 days following last dose | Incidence of anti-drug antibodies (ADA) will be measured |
Countries
China
Outcome results
None listed