Advanced / Metastatic Solid Tumor
Conditions
Brief 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.
Interventions
DRUGABO2102 Injection
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Anti-PD-1 antibody, administered intravenously
Sponsors
Suzhou Abogen Biosciences Co., Ltd.
Abogen Biosciences (Shanghai) Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age at time of informed consent. 2. Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations 3. Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors. 4. According to RECIST v1.1, at least one measurable lesion is required. 5. No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol. 6. Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.
Exclusion criteria
1. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix. 2. Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy . 3. Received KRAS cancer vaccine before. 4. History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy. 5. History of allogeneic organ transplantation or graft-versus-host disease (GVHD). 6. Any active infection (except for hepatitis virus infection) requires systemic treatment. 7. Absence of spleen 8. Known psychiatric disorder or drug abuse that may interfere with the trial requirements 9. Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. 10. Other conditions that Investigators consider inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab | 28 days after the first dose of study treatment |
| Part I: Incidence and severity of adverse events | from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy |
| Part II: ORR evaluated by investigators according to RECIST v1.1 criteria | from the first dose of study treatment to up to 3 years |
| Part II: PFS evaluated by investigators according to RECIST v1.1 criteria | from the first dose of study treatment to up to 3 years |
Countries
China
Contacts
CONTACTXiao Zhang
Outcome results
None listed