A Phase 1/2 interventional study of JAB-23E73 and JAB-23E73 in Advanced Solid Tumors, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment
This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 in adult participants with advanced solid tumors
Study JAB-23E73-1002 is a 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 and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b. The indication expansion phase will further explore the efficacy and safety in advanced KRAS-alternated tumors which consist of 3 cohorts: Cohort C1, the CRC cohort; Cohort C2, the PDAC cohort; and Cohort C3, other solid tumor cohort.
Exclusion Criteria:
Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.
Drug: JAB-23E73
Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors
Drug: JAB-23E73
Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.
Drug: JAB-23E73
Oral administration
Oral administration
Oral administration
Dose Escalation (Phase 1a): Determine the Maximum tolerated dose (MTD) of JAB-23E73 monotherapy.
Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) during the first 21 days of treatment. A DLT is defined as any toxicities that meet the criteria for a DLT assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 during the evaluation period at any dose.
Time frame: Up to 1 year
Dose Escalation (Phase 1a): Evaluate the overall safety and tolerability of JAB-23E73.
Safety and tolerability of repeated cycles from first drug administration up to the Safety Follow Up Visit (SFUV)
Time frame: Up to 2 years
Dose Expansion/Optimization (Phase 1b): Determine the Recommended Phase 2 Dose (RP2D) of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors.
RP2D determined by MTD, long term tolerability, PK, efficacy and any other relevant data as available.
Time frame: Up to 2 years
Indication Expansion (Phase 2a): Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.
ORR, defined as the percentage of patients with the best overall response of confirmed partial response (PR), or complete response (CR) per RECIST v1.1.
Time frame: Up to 3 years
Dose Expansion/Optimization (Phase 1b): Determine the RP2D of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors.
RP2D determined by MTD, long term tolerability, PK, efficacy and any other relevant data as available.
Time frame: Up to 2 years
Indication Expansion (Phase 2a): Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.
ORR, defined as the percentage of patients with the best overall response of confirmed PR, or CR per RECIST v1.1.
Time frame: Up to 3 years
Dose Escalation (Phase 1a): Overall Response Rate (ORR)
Objective response rate (ORR) defined as the percentage of patients with the best overall response of confirmed partial response (PR), or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 years
Dose Escalation (Phase 1a): Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Cmax of JAB-23E73
Time frame: Up to 2 years
Dose Expansion/Optimization (Phase 1b): Overall Response Rate (ORR)
ORR, defined as the percentage of patients with the best overall response of confirmed PR, or CR per RECIST v1.1.
Time frame: Up to 2 years
Dose Expansion/Optimization (Phase 1b): Evaluate the overall safety and tolerability of JAB-23E73.
Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures.
Time frame: Up to 2 years
Dose Expansion/Optimization (Phase 1b): Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Cmax of JAB-23E73
Time frame: Up to 2 years
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Jacobio Pharmaceuticals Co., Ltd.