A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

NCT06959615 | Recruiting Phase 1

• 1 other identifier: JAB-23E73-1001
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Advanced Solid Tumor

Keywords

KRAS; KRAS mutation; KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D; Pan-KRAS; NSCLC; Pancreas cancer; Colorectal cancer; KRAS-mutant tumor; Targeted Therapy; JAB-23E73

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 2 years

Secondary Outcomes (10)

• Phase 1/2a: Adverse events

  Up to approximately 2 years

• Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73

  Up to approximately 2 years

• Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73

  Up to approximately 2 years

• Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73

  Up to approximately 2 years

• Phase 1: ORR

  Up to approximately 2 years

Study Arms (2)

Phase 1 Dose Exploration

EXPERIMENTAL

Monotherapy, dose escalation

Drug: JAB-23E73

Phase 2a Dose Expansion

EXPERIMENTAL

Monotherapy, dose expansion

Drug: JAB-23E73

Interventions

JAB-23E73 DRUG

Administered orally

Phase 1 Dose Exploration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
• Able to provide an archived tumor tissue sample or fresh biopsy sample.
• Life expectancy ≥3 months at the start of treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• ≥1 measurable lesion per RECIST v1.1.
• Adequate organ function.

You may not qualify if:

• Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
• Previous treatment with rat sarcoma (RAS) targeting agents.
• Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
• Impaired cardiovascular function or clinically significant cardiac disease.
• Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec.
• Females who are pregnant or breastfeeding.

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (32)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230001, China

NOT YET RECRUITING

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Beijing Chest Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

NOT YET RECRUITING

Fujian cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530012, China

RECRUITING

National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College

Langfang, Hebei, 065000, China

RECRUITING

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 200032, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

The First Affiliate of Soochow University

Suzhou, Jiangsu, 215006, China

NOT YET RECRUITING

The First Affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

ShanXi Cancer Hospital

Taiyuan, Shanxi, 650118, China

RECRUITING

The First Affiliated hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, 300211, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

The Second Affiliate Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jacobio Pharmaceuticals

CONTACT

86 10 56315466; clinicaltrials@jacobiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: November 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (32)