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New treatment option for Advanced / Metastatic Solid Tumor
Official title Study of ABO2102 in KRAS-Mutated Solid Tumors
ClinicalTrials.gov ID: NCT07455617
What this study is testing
What is ABO2102 Injection?
ABO2102 Injection is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for advanced / metastatic solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age at time of informed consent.
- Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring...
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
- According to RECIST v1.1, at least one measurable lesion is required.
- No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective...
You likely can't join if
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or...
- Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
- Received KRAS cancer vaccine before.
- History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
- History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- Any active infection (except for hepatitis virus infection) requires systemic treatment.
See the full eligibility criteria
- ≥18 years of age at time of informed consent.
- 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
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
- According to RECIST v1.1, at least one measurable lesion is required.
- 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.
- Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.
- 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.
- Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
- Received KRAS cancer vaccine before.
- History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
- History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- Any active infection (except for hepatitis virus infection) requires systemic treatment.
- Absence of spleen
- Known psychiatric disorder or drug abuse that may interfere with the trial requirements
- Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
- Other conditions that Investigators consider inappropriate for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.