Trials / Recruiting
RecruitingNCT07455617
Study of ABO2102 in KRAS-Mutated Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 101 (estimated)
- Sponsor
- Suzhou Abogen Biosciences Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABO2102 Injection | mRNA encoding mutant KRAS neoantigens, administrated intramuscularly |
| DRUG | Sintilimab injection | Anti-PD-1 antibody, administered intravenously |
Timeline
- Start date
- 2026-03-24
- Primary completion
- 2029-06-01
- Completion
- 2030-02-01
- First posted
- 2026-03-06
- Last updated
- 2026-04-06
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07455617. Inclusion in this directory is not an endorsement.