Pancreatic CancerEarly Phase 1NCT07649928
A Study of Dose Escalation of ES502 in Patients With Advanced Pancreatic Cancer
A Early Phase 1 study testing ES502 Injection in people with Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
ESSIGHT-HJG-ES502-01 is a dose-escalation study of ES502 in patients with advanced pancreatic cancer. The study will enroll patients with advanced, RAS G12V positive pancreatic cancer who have no effective treatment options available (HLA genotyping required). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ES502 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to Jun 2029
- Phase
- Early Phase 1
- 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
- -
- To be enrolled in this study, participants must meet all of the following inclusion criteria:
- Age ≥18 years, regardless of gender;
- Available fresh or archived tumor tissue samples (within the past 5 years) for testing at screening;
- Individuals with histologically or cytologically confirmed advanced solid tumors for whom no standard therapy exists, who are refractory to standard therapy, or who are deemed unsuitable for standard therapy by the investigator. Tumor types include but are not limited to: pancreatic cancer, colorectal cancer, non-small cell lung cancer, intrahepatic cholangiocarcinoma, gallbladder cancer, ovarian cancer, endometrial cancer, and intestinal cancer;
- RAS G12V mutation (KRAS/NRAS/HRAS) and positivity for HLA-DPB1*03:01, *14:01, *25:01, or *104:01;
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- Individuals with at least one measurable lesion (defined per RECIST v1.1 as a lesion with the longest diameter ≥10 mm, or a lymph node with a short axis of ≥15 mm); lesions that have undergone radiotherapy or other local therapies are not considered target lesions unless they demonstrate clear progression;
- ECOG score: 0-1;
- Expected survival greater than 3 months;
- Adequate hematological and organ function, as evidenced by the following laboratory tests (the individual must not have received a blood transfusion, long-acting EPO or long-acting G-CSF within 14 days before study treatment, or not have received short-acting EPO or short-acting G-CSF within 7 days before study treatment): 1) hematology: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count (PLT) ≥100 × 10⁹/L, hemoglobin (Hb) ≥90 g/L; 2) liver function test: both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5 × ULN. Exceptions: liver metastasis, AST and/or ALT ≤5 × ULN; Gilbert's syndrome, TBIL ≤3 × ULN; pancreatic head cancer or biliary obstruction, TBIL ≤3 × ULN; 3) kidney function test: creatinine clearance (CrCL) ≥50 mL/min (by Cockcroft-Gault formula); 4) coagulation function test: activated partial thromboplastin time (APTT) ≤1.5 × ULN and international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; 5) echocardiography: left ventricular ejection fraction (LVEF) ≥50%; eligibility for enrollment of individuals with out-of-range laboratory results should be determined at the investigator's discretion.
- Women of childbearing potential who agree to use at least one medically recognized method for contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment and for 1 year after the last treatment, and have a negative pregnancy test result at screening;
- Prior antitumor treatment-related adverse events (AEs) (per NCI-CTCAE v6.0) have resolve to ≤ Grade 1 at screening, except for alopecia, Grade 2 hypothyroidism, and non-clinically significant or asymptomatic laboratory abnormalities;
- Individuals who fully understand the informed consent information, agree to participate in this clinical study, and voluntarily sign the Informed Consent Form (ICF).
Who cannot join
- -
- To be enrolled in this study, participants must not meet any of the following exclusion criteria:
- To be enrolled in this study, participants must not meet any of the following exclusion criteria:
- Individuals with the following tumors:
- Malignant tumors other than those under investigation in this study (except for cured thyroid cancer, skin basal cell carcinoma, or cervical carcinoma in situ) within the past 5 years;
- Meningeal metastases;
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- Brain metastases, except for individuals who have received systematic and radical therapy (radiotherapy or surgery) for brain metastases, demonstrated radiologically stable disease for at least 4 weeks, discontinued systemic corticosteroids for more than 2 weeks, and remain asymptomatic.
- Individuals with the following conditions:
- Received prior targeted therapy targeting RAS-G12V within 4 weeks before the first dose, or within 5 half-lives of the therapeutic agent, whichever is longer;
- Participation in other clinical studies involving an investigational product within 4 weeks before the first dose;
- Use of systemic antitumor therapy (including but not limited to chemotherapy, radiotherapy, biotherapy, immunotherapy, and cell therapy) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose;
- Receipt of major surgery without complete recovery within 4 weeks before the first dose, or planning to undergo major surgery during the study;
- Receipt of systemic immunosuppressants or systemic corticosteroids within 1 week before the first dose;
- Receipt of live-attenuated vaccines within 4 weeks before the first dose, or planning to receive such vaccines during the study;
- Planning to receive any other systemic antitumor therapy (chemotherapy, radiotherapy, biotherapy, immunotherapy, cell therapy, etc.) during the study;
- Symptomatic ascites, pleural effusion or pericardial effusion requiring drainage at screening, or history of drainage for serous effusion within 4 weeks before the first dose;
- History of clinically significant cardiovascular disorders at screening, including but not limited to congestive heart failure (NYHA Class ≥ II), unstable angina, myocardial infarction, stroke or transient ischemic attack (TIA), severe arrhythmias (including but not limited to atrial fibrillation or paroxysmal supraventricular tachycardia, complete left bundle branch block or third-degree atrioventricular block with clinical significance and requiring clinical intervention), or poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) within 6 months before enrollment;
- QT interval corrected by Fridericia's formula (QTcF) ≥470 ms;
- History of severe infection within 4 weeks before the first dose; active infection requiring therapeutic intravenous antibiotics within 2 weeks before the first dose. Use of prophylactic antibiotics is not an exclusion criterion;
- Active autoimmune diseases, or any conditions requiring systemic corticosteroids or immunosuppressants (prednisone at ≥20 mg/day or an equivalent dose) at screening;
- History or evidence of clinically unstable or poorly controlled disorders (including but not limited to cardiac, pulmonary, renal, hepatic, metabolic or hematological disorders) at screening;
- History of severe allergy or known hypersensitivity to the investigational product or its components;
- Organ transplantation, allogeneic stem cell transplantation or renal replacement therapy in the past or at screening;
- Pulmonary embolism, pulmonary fibrosis, interstitial lung disease or acute lung disease in the past or at screening;
- Positivity for Treponema pallidum antibody, positivity for human immunodeficiency virus (HIV) antibody, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Definition of active HBV infection: positivity for hepatitis B surface antigen (HBsAg), and HBV DNA above the ULN; definition of active HCV infection: positivity for hepatitis C antibody, and HCV RNA above the ULN. Such conditions unsuitable for enrollment as judged by the investigator;
- Other circumstances inappropriate for participation in this study as considered by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Chenlei Wen, +86-13761638756, wcl12161@rjh.com.cn
Baiyong Shen
About this study
Official title: A Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of ES502 Injection in Patients With Advanced Pancreatic Cancer
ESSIGHT-HJG-ES502-01 is a dose-escalation study of ES502 in patients with advanced pancreatic cancer. The study will enroll patients with advanced, RAS G12V positive pancreatic cancer who have no effective treatment options available (HLA genotyping required).
Read the detailed description
The study will adopt the standard "3+3" design., with a first-in-human (FIH) dose of 20 μg administered once every four weeks (Q4W). Subsequent dosing frequency will be adjusted based on pharmacodynamics and pharmacokinetics data. The primary objectives of this study are to evaluate the safety and tolerability of ES502 and to determine its maximum tolerated dose (MTD). The secondary objectives are to evaluate its antitumor activity, pharmacokinetics (PK), and pharmacodynamics (PD).
- Conditions
- Pancreatic Cancer
- Being tested
- ES502 Injection
- Keywords
- RASG12V, HLA, T-cell engager
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES502 InjectionDrug
Bispecific soluble HLA-DP restricted RASG12V specific T-cell receptor fused to anti-CD3 with Fc
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation cohort | Experimental | A dose-escalation study will be conducted following the standard 3+3 design, with doses of 20, 60, 180, and 540 μg. A total of 10-24 subjects are planned to be enrolled. Depending on the subject's conditions (including but not limited to safety results, pharmacokinetic and pharmacodynamic data, etc.), and under the premise of ensuring subject safety, the investigator and/or ethics committee may decide to increase the dose or add new dose groups. Receives: Drug: ES502 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ES502 in subjects with advanced solid tumors
DLT, and incidence and severity of adverse effects.
Measured: 2 years
To determine the maximum tolerated dose (MTD)
Measured: 2 years
Secondary outcomes (13)
Preliminary antitumor activity
Objective response rate (ORR),%
Measured: 2 years
Preliminary antitumor activity
Disease control rate (DCR),%
Measured: 2 years
Preliminary antitumor activity
Duration of response (DOR), in week, in month
Measured: 2 years
Preliminary antitumor activity
Progression-free survival (PFS) ,in month
Measured: 2 years
Preliminary antitumor activity
Overall survival (OS), in month
Measured: 2 years
To evaluate the immunogenicity of ES502 in subjects with advanced solid tumors
Immunogenicity: Seropositivity rates of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs)
Measured: 2 years
Pharmacokinetic (PK)
Maximum plasma concentration (Cmax), ng/mL
Measured: 2 years
Pharmacokinetic (PK)
Half-life (t1/2) in minutes
Measured: 2 years
Pharmacokinetic (PK)
Time to Cmax (Tmax) in hours
Measured: 2 years
Pharmacokinetic (PK)
Area under the plasma concentration-time curve (AUC0-∞), ng·h/mL
Measured: 2 years
Pharmacokinetic (PK)
Mean residence time (MRT) in hours
Measured: 2 years
Pharmacokinetic (PK)
Plasma clearance (CL),mL/min
Measured: 2 years
Pharmacokinetic (PK)
Volume of distribution (Vd),L/kg
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start18 May 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation will proceed through 4 predetermined dose levels following the traditional "3+3" trial design. The dose will be escalated sequentially from the starting level. The study may proceed to the next higher dose cohort following confirmation by the Safety Monitoring Committee (SMC) that all subjects in the current cohort have safely passed the 28-day dose-limiting toxicity (DLT) observation period after the first dose. The starting dose cohort will utilize an accelerated titration design with 1-6 subjects, followed by subsequent cohorts of 3-6 subjects each, for a total of 10-24 participants.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Essight Bio Co.,Ltd
- Responsible party
- Principal investigator, BAIYONG SHEN, Ruijin Hospital
- Investigators
- Baiyong Shen, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649928
- Sponsor's protocol ID
- ESSIGHT-HJG-ES502-01
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of ES502 Injection in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07649928
- Acronym / sponsor ID
- ESSIGHT-HJG-ES502-01
- Conditions
- Pancreatic Cancer
- Keywords
- RASG12V, HLA, T-cell engager
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Essight Bio Co.,Ltd
- Study start
- 18 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 16 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.
ESSIGHT-HJG-ES502-01 is a dose-escalation study of ES502 in patients with advanced pancreatic cancer. The study will enroll patients with advanced, RAS G12V positive pancreatic cancer who have no effective treatment options available (HLA genotyping required).
Detailed description
The study will adopt the standard "3+3" design., with a first-in-human (FIH) dose of 20 μg administered once every four weeks (Q4W). Subsequent dosing frequency will be adjusted based on pharmacodynamics and pharmacokinetics data. The primary objectives of this study are to evaluate the safety and tolerability of ES502 and to determine its maximum tolerated dose (MTD). The secondary objectives are to evaluate its antitumor activity, pharmacokinetics (PK), and pharmacodynamics (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation will proceed through 4 predetermined dose levels following the traditional "3+3" trial design. The dose will be escalated sequentially from the starting level. The study may proceed to the next higher dose cohort following confirmation by the Safety Monitoring Committee (SMC) that all subjects in the current cohort have safely passed the 28-day dose-limiting toxicity (DLT) observation period after the first dose. The starting dose cohort will utilize an accelerated titration design with 1-6 subjects, followed by subsequent cohorts of 3-6 subjects each, for a total of 10-24 participants.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort | Experimental | Drug: ES502 InjectionA dose-escalation study will be conducted following the standard 3+3 design, with doses of 20, 60, 180, and 540 μg. A total of 10-24 subjects are planned to be enrolled. Depending on the subject's conditions (including but not limited to safety results, pharmacokinetic and pharmacodynamic data, etc.), and under the premise of ensuring subject safety, the investigator and/or ethics committee may decide to increase the dose or add new dose groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- To be enrolled in this study, participants must meet all of the following inclusion criteria:
- Age ≥18 years, regardless of gender;
- Available fresh or archived tumor tissue samples (within the past 5 years) for testing at screening;
- Individuals with histologically or cytologically confirmed advanced solid tumors for whom no standard therapy exists, who are refractory to standard therapy, or who are deemed unsuitable for standard therapy by the investigator. Tumor types include but are not limited to: pancreatic cancer, colorectal cancer, non-small cell lung cancer, intrahepatic cholangiocarcinoma, gallbladder cancer, ovarian cancer, endometrial cancer, and intestinal cancer;
Key exclusion criteria (26 listed)
- -
- To be enrolled in this study, participants must not meet any of the following exclusion criteria:
- To be enrolled in this study, participants must not meet any of the following exclusion criteria:
- Individuals with the following tumors:
- Individuals with the following conditions:
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 |
|---|---|---|
| ES502 InjectionBispecific soluble HLA-DP restricted RASG12V specific T-cell receptor fused to anti-CD3 with Fc | Drug | Dose escalation cohort |
Primary outcome
To evaluate the safety and tolerability of ES502 in subjects with advanced solid tumors
Time frame: 2 years
DLT, and incidence and severity of adverse effects.
To determine the maximum tolerated dose (MTD)
Time frame: 2 years
13 secondary outcomes
Preliminary antitumor activity
Time frame: 2 years
Preliminary antitumor activity
Time frame: 2 years
Preliminary antitumor activity
Time frame: 2 years
Preliminary antitumor activity
Time frame: 2 years
Preliminary antitumor activity
Time frame: 2 years
To evaluate the immunogenicity of ES502 in subjects with advanced solid tumors
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 years
Pharmacokinetic (PK)
Time frame: 2 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 16 Jun 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.
Baiyong Shen study director
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ES502 Injection in people with Pancreatic Cancer, run by Ruijin Hospital at 1 site 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 13 inclusion and 26 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Chenlei Wen (+86-13761638756, wcl12161@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of ES502 in subjects with advanced solid tumors (time frame: 2 years). 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 16 Jun 2026.