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Advanced Solid TumorPhase 1/2NCT06959615

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

A Phase 1/2 study testing JAB-23E73 in people with Advanced Solid Tumor, run by Jacobio Pharmaceuticals Co., Ltd. at 32 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Advanced Solid Tumor
What is being tested?
JAB-23E73
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
32 sitesChina
Study dates
22 Nov 2024to 31 Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jacobio Pharmaceuticals contact

86 10 56315466

clinicaltrials@jacobiopharma.com

32 sites in 1 country

China32 sites, 32 recruiting

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

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100032

    Recruiting

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 100032

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 200032

    Not yet recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Not yet recruiting

  • Fujian cancer Hospital

    Fuzhou, Fujian, 350014

    Not yet recruiting

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

    Guangzhou, Guangdong, 510120

    Recruiting

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang, 150081

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

    Recruiting

  • The Second Affiliate Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Not yet recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230001

    Not yet recruiting

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

    Langfang, Hebei, 065000

    Recruiting

  • The First Affiliated hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Not yet recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530012

    Recruiting

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Not yet recruiting

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Not yet recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • The First Affiliate of Soochow University

    Suzhou, Jiangsu, 215006

    Not yet recruiting

  • ShanXi Cancer Hospital

    Taiyuan, Shanxi, 650118

    Recruiting

  • Tianjin Medical University Cancer Institute&Hospital

    Tianjin, Tianjin Municipality, 300211

    Not yet recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430030

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Recruiting

  • The First Affiliated hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Recruiting

  • The First Affiliated hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

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.

Read the detailed description

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.

Being tested
JAB-23E73
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
Medical subject headings
Pancreatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JAB-23E73Drug

    Administered orally

  • JAB-23E73Drug

    Administered orally

Study groups in NCT06959615
Study groupRoleWhat they receive
Phase 1 Dose ExplorationExperimentalMonotherapy, dose escalation
Receives: Drug: JAB-23E73
Phase 2a Dose ExpansionExperimentalMonotherapy, dose expansion
Receives: Drug: JAB-23E73

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 21 days

  2. 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.

    Measured: Up to approximately 2 years

Secondary outcomes (10)

  1. Phase 1/2a: Adverse events

    Incidence and severity of treatment-emergent Adverse Events (TEAEs), treatment-related Adverse Events (TRAEs) and serious Adverse Events (SAEs)

    Measured: Up to approximately 2 years

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

    PK: Cmax of JAB-23E73

    Measured: Up to approximately 2 years

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

    PK: Tmax of JAB-23E73

    Measured: Up to approximately 2 years

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

    PK: AUC of JAB-23E73

    Measured: Up to approximately 2 years

  5. Phase 1: ORR

    ORR is defined as the proportion of patients with a BOR of confirmed CR or confirmed PR per RECIST v1.1.

    Measured: Up to approximately 2 years

  6. 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

    Measured: Up to approximately 2 years

  7. 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.

    Measured: Up to approximately 2 years

  8. 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

    Measured: Up to approximately 2 years

  9. 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.

    Measured: Up to approximately 2 years

  10. 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.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start22 Nov 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959615
Sponsor's protocol ID
JAB-23E73-1001
Status last verified
Jan 2026
First submitted
28 Apr 2025
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-23E73 in people with Advanced Solid Tumor, run by Jacobio Pharmaceuticals Co., Ltd. at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacobio Pharmaceuticals (86 10 56315466, clinicaltrials@jacobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of participants with dose limiting toxicities (DLT) (time frame: Up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06959615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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