Study of ABO2102 in KRAS-Mutated Solid Tumors
NCT07455617 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2026-04-06
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
- Advanced / Metastatic Solid Tumor
Interventions
- DRUG
-
ABO2102 Injection
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
- DRUG
-
Sintilimab injection
Anti-PD-1 antibody, administered intravenously
Sponsors & Collaborators
-
Abogen Biosciences (Shanghai) Co., Ltd
collaborator INDUSTRY -
Suzhou Abogen Biosciences Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-24
- Primary Completion
- 2029-06-30
- Completion
- 2030-02-28
- FDA Drug
- Yes
Countries
- China
Study Locations
More Related Trials
-
A Study of SY-5933 in Patients With Advanced Solid Tumors Harboring the KRAS p.G12C Mutation
NCT06006793 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
NCT04192344 ·Status: RECRUITING ·Phase: PHASE1
-
Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors
NCT07272590 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors
NCT06596915 ·Status: RECRUITING ·Phase: PHASE1
-
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
NCT04686682 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.
NCT07205198 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors
NCT05501912 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
NCT06959615 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
NCT06120075 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT03071757 ·Status: COMPLETED ·Phase: PHASE1
-
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
NCT07335497 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors
NCT06331559 ·Status: TERMINATED ·Phase: PHASE1
-
Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors
NCT04400383 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.
NCT05735275 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors
NCT04190628 ·Status: TERMINATED ·Phase: PHASE1
-
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
NCT05490472 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of BA1202 in Patients With Advanced Solid Tumors
NCT05909241 ·Status: RECRUITING ·Phase: PHASE1
-
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
NCT07086768 ·Status: RECRUITING ·Phase: PHASE1
-
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
NCT06895928 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS])
NCT04835714 ·Status: TERMINATED ·Phase: PHASE1
-
Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors
NCT05701709 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies
NCT07213830 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
NCT00095914 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors
NCT05627063 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors
NCT02313012 ·Status: TERMINATED ·Phase: PHASE1