A Phase 1/2 interventional study of JAB-23E73 and JAB-23E73 in Advanced Solid Tumor, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 32 sites in China. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment
This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.
Study JAB-23E73-1001 is a global multicenter, open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity of JAB-23E73 as a single agent in adult patients with advanced solid tumors with KRAS alteration. This study consists of a Phase 1a dose-escalation, followed by Phase 1b dose-expansion (dose optimization) and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. Then, two of the alternative dosages of JAB-23E73 will be selected to further evaluate the efficacy, safety and PK in patients with KRAS-alternated NSCLC or other tumors, and patients may be further selected by certain/several types of KRAS-alternations based on dose escalation data. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b.
Exclusion Criteria:
Monotherapy, dose escalation
Drug: JAB-23E73
Monotherapy, dose expansion
Drug: JAB-23E73
Administered orally
Administered orally
Phase 1: Number of participants with dose limiting toxicities (DLT)
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
Time frame: Up to 21 days
Phase 2a: Objective response rate (ORR)
ORR is defined as the proportion of patients with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1.
Time frame: Up to approximately 2 years
Phase 1/2a: Adverse events
Incidence and severity of treatment-emergent Adverse Events (TEAEs), treatment-related Adverse Events (TRAEs) and serious Adverse Events (SAEs)
Time frame: Up to approximately 2 years
Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73
PK: Cmax of JAB-23E73
Time frame: Up to approximately 2 years
Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73
PK: Tmax of JAB-23E73
Time frame: Up to approximately 2 years
Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73
PK: AUC of JAB-23E73
Time frame: Up to approximately 2 years
Phase 1: ORR
ORR is defined as the proportion of patients with a BOR of confirmed CR or confirmed PR per RECIST v1.1.
Time frame: Up to approximately 2 years
Phase 1/2a: Time to Response (TTR)
TTR is defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Phase 1/2a: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Time frame: Up to approximately 2 years
Phase 1/2a: Disease Control Rate (DCR)
DCR is defined as the proportion of patients with CR, PR, or stable disease (SD) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Phase 1/2a: Duration of Response (DoR)
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Time frame: Up to approximately 2 years
Phase 2a: Overall Survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Time frame: Up to approximately 2 years
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Jacobio Pharmaceuticals Co., Ltd.