Metastatic Pancreatic Ductal AdenocarcinomaPhase 1/2NCT07640295
Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
A Phase 1/2 study testing JAB-23E73 tablet，nab-paclitaxel，gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Jacobio Pharmaceuticals Co., Ltd. at 13 sites in China.
Trial summary
The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- JAB-23E73 tablet，nab-paclitaxel，gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 13 sitesChina
- Study dates
- 16 Jul 2026to 31 Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.
- 3. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).
- 5. ECOG performance status score of 0 or 1. 6. Adequate organ function.
Who cannot join
- Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
- A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
- Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class.
- Women who are pregnant or breast-feeding.
- Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Beijing Cancer Hospital, 86+13911219511, doctorshenlin@sina.com
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
Beijing Tsinghua Changgung Hospital, 86+13366152815, joelbmu@126.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha
Hunan Cancer Hospital, 86+18673181133, liuzhenyang@hnca.org.cn
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Zhejiang Cancer Hospital, 86+13858195803, hzyingjieer@163.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin
Harbin Medical University Cancer Hospital, 86+13845120210, yanqiaozhang@126.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu Province Hospital, 86+13585172066, Xiaofengch198019@126.com
- Recruiting
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
Shanghai Jiaotong University School of Medicine Ruijin Hospita, 86+ ext. 86+13901943778, shenby@shsmu.edu.cn
- Recruiting
ShanXi Cancer Hospital
Taiyuan
ShanXi Cancer Hospital, 86+13811176181, WXCAMS@126.com
- Not yet recruiting
Hubei Province Hospital
Wuhan
Hubei Province Hospital, 86+15629019627, 971070316@qq.com
- Recruiting
Wuhan Union Hospital Of China
Wuhan
Wuhan Union Hospital Of China, 86+13720117761, heshuiwu@hust.ed.cn
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Zhongnan Hospital of Wuhan University, 86+13971235235 ext. 86-13971235235, pjxp888@126.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou
Henan Cancer Hospital, 86+13937100233, 2290773710@qq.com
- Not yet recruiting
The First Affiliated hospital of Zhengzhou University
Zhengzhou
The First Affiliated hospital of Zhengzhou University, 86+13676932999, yanruqin@163.com
About this study
Official title: A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations
The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.
Read the detailed description
This is a phase Ib/III, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of pan-KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in treatment-naive participants with metastatic PDAC.
Phase Ib study：an open-label study, including dose escalation and backfill cohorts, with approximately 40-80 participants planned to be enrolled (including approximately 20-50 participants in the backfill cohort),Aiming to determine the recommended phase III dose [RP3D] within investigated patient population groups.
Phase III: Following confirmation of the efficacy and safety of JAB-23E73 in combination with the AG regimen in Phase Ib, a Phase III trial will be initiated to evaluate the efficacy and safety of JAB-23E73 plus AG versus AG alone for the treatment of metastatic PDAC.
- Being tested
- JAB-23E73 tablet，nab-paclitaxel，gemcitabine
- Keywords
- KRAS, KRAS mutation, KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A,, Pan-KRAS, Pancreatic ductal adenocarcinoma, KRAS-mutant tumor, Targeted Therapy, JAB-23E73
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-23E73 tablet，nab-paclitaxel，gemcitabineDrug
Orally, intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation/backfill | Experimental | Not described Receives: Drug: JAB-23E73 tablet，nab-paclitaxel，gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLT)
The number and proportion of participants who experienced dose-limiting toxicities (DLT).
Measured: Up to 28 days
Adverse events.safety evaluation
The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: Up to approximately 3 years
Secondary outcomes (9)
ORR
Objective response rate, ORR is defined as the proportion of participants with confirmed complete response or partial response
Measured: Up to approximately 3 years
DOR
Duration of response, DOR is defined as the time from the first documented CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first
Measured: Up to approximately 3 years
TTR
Time to Response, TTR is defined as the time from the first dose of study treatment to the first documented CR or PR.
Measured: Up to approximately 3 years
PFS
Progression-Free Survival , PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 3 years
DCR
Disease Control Rate, DCR is defined as the proportion of participants whose best overall response is CR, PR, or SD..
Measured: Up to approximately 3 years
OS
Overall Survival , OS is defined as the time from the first dose of study treatment to death from any cause.
Measured: Up to approximately 3 years
PK
maximum plasma concentration (Cmax)
Measured: Up to approximately 3 years
PK
area under the plasma concentration-time curve (AUC)
Measured: Up to approximately 3 years
PK
trough plasma concentration (Ctrough)
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start16 Jul 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacobio Pharmaceuticals, Study director, Jacobio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640295
- Sponsor's protocol ID
- JAB-23E73-2001
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations
- ClinicalTrials.gov ID
- NCT07640295
- Acronym / sponsor ID
- JAB-23E73-2001
- Keywords
- KRAS, KRAS mutation, KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A,, Pan-KRAS, Pancreatic ductal adenocarcinoma, KRAS-mutant tumor, Targeted Therapy, JAB-23E73
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.
Detailed description
This is a phase Ib/III, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of pan-KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in treatment-naive participants with metastatic PDAC.
Phase Ib study：an open-label study, including dose escalation and backfill cohorts, with approximately 40-80 participants planned to be enrolled (including approximately 20-50 participants in the backfill cohort),Aiming to determine the recommended phase III dose [RP3D] within investigated patient population groups.
Phase III: Following confirmation of the efficacy and safety of JAB-23E73 in combination with the AG regimen in Phase Ib, a Phase III trial will be initiated to evaluate the efficacy and safety of JAB-23E73 plus AG versus AG alone for the treatment of metastatic PDAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation/backfill | Experimental | Drug: JAB-23E73 tablet，nab-paclitaxel，gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.
- 3. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).
- 5. ECOG performance status score of 0 or 1. 6. Adequate organ function.
Key exclusion criteria (5 listed)
- Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
- A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
- Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class.
- Women who are pregnant or breast-feeding.
- Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-23E73 tablet，nab-paclitaxel，gemcitabineOrally, intravenous (IV) infusion | Drug | Dose escalation/backfill |
Primary outcome
Dose limiting toxicities (DLT)
Time frame: Up to 28 days
The number and proportion of participants who experienced dose-limiting toxicities (DLT).
Adverse events.safety evaluation
Time frame: Up to approximately 3 years
The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
9 secondary outcomes
ORR
Time frame: Up to approximately 3 years
DOR
Time frame: Up to approximately 3 years
TTR
Time frame: Up to approximately 3 years
PFS
Time frame: Up to approximately 3 years
DCR
Time frame: Up to approximately 3 years
OS
Time frame: Up to approximately 3 years
PK
Time frame: Up to approximately 3 years
PK
Time frame: Up to approximately 3 years
PK
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacobio Pharmaceuticals study director
Jacobio Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JAB-23E73 tablet，nab-paclitaxel，gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Jacobio Pharmaceuticals Co., Ltd. at 13 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 3 inclusion and 5 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Dose limiting toxicities (DLT) (time frame: Up to 28 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?
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 27 Aug 2026.