Trials / Completed
CompletedNCT05043298
A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBI 360 Injection | IBI 360 dose level of escalation IV Q3W Day 1 |
| DRUG | IBI 360 Injection Sintilimab | IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1 |
Timeline
- Start date
- 2021-10-27
- Primary completion
- 2023-08-30
- Completion
- 2023-08-30
- First posted
- 2021-09-14
- Last updated
- 2024-10-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05043298. Inclusion in this directory is not an endorsement.