Trials / Completed
CompletedNCT05174585
JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | JAB-BX102 (anti-CD73 monoclonal antibody) | Administered by intravenous infusion (IV) |
| BIOLOGICAL | pembrolizumab (anti-PD-1 monoclonal antibody) | Administered by intravenous infusion (IV) |
Timeline
- Start date
- 2022-08-18
- Primary completion
- 2025-05-09
- Completion
- 2025-05-09
- First posted
- 2022-01-03
- Last updated
- 2026-01-06
Locations
6 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05174585. Inclusion in this directory is not an endorsement.