ABO2102 for KRAS-mutated advanced 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

This study tests whether ABO2102, alone or combined with the immunotherapy drug sintilimab, is safe and shows early anti-tumor activity in adults with advanced solid tumors that have KRAS mutations.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Abogen Biosciences Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07455617 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label Phase 1 trial that gives ABO2102 as monotherapy and in combination with sintilimab to adults with histologically confirmed advanced or metastatic solid tumors harboring KRAS mutations. The study requires at least one measurable lesion per RECIST v1.1 and collects safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic data. Early signs of anti-tumor activity will be recorded alongside adverse events to define acceptable doses and combination regimens. The trial is conducted at participating centers including Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.

Who should consider this trial

Good fit: Adults (≥18) with genetically confirmed KRAS-mutated locally advanced or metastatic solid tumors, at least one measurable lesion, adequate organ function, and willingness to use effective contraception are the intended participants.

Not a fit: Patients without KRAS mutations, those with recent other active cancers, or those with severe hematologic, hepatic, renal or coagulation dysfunction are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option that controls tumors driven by KRAS mutations and potentially slows disease progression.

How similar studies have performed: Some KRAS-targeted agents (for example KRAS G12C inhibitors) and certain immunotherapy combinations have shown activity in selected KRAS-mutant cancers, but many KRAS alterations remain difficult to target and this specific approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiao Zhang

Conditions Advanced / Metastatic Solid Tumor