Study of ABO2102 in KRAS-Mutated Solid Tumors

Abogen Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Advanced / Metastatic Solid Tumor

Treatments: Drug: Sintilimab injection; Drug: ABO2102 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07455617

ABO2102-102

Details and patient eligibility

About

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.

Enrollment: 101 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

ABO2102 Injection

Experimental group

Description:

Monotherapy

Treatment:

Drug: ABO2102 Injection

ABO2102 Injection and Sintilimab Injection

Experimental group

Description:

ABO2102 Injection in combination with Sintilimab Injection

Treatment:

Drug: ABO2102 Injection

Drug: Sintilimab injection