Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2NCT07685470
MRG003 With Gemcitabine for Second-line Advanced PDAC
A Phase 1/2 study testing becotatugvedotin plus gemcitabine in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Second Line Treatment, run by Peking Union Medical College Hospital.
Trial summary
This is a Phase Ib/II clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Second Line Treatment
- What is being tested?
- becotatugvedotin plus gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2026to 7 Jun 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status score of 0-2;
- Histopathologically confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC);
- Failure of prior first-line systemic therapy:
- Radiographic progression or worsening of clinical symptoms; disease progression occurring within 6 months after completion of neoadjuvant/adjuvant therapy is also considered first-line treatment failure.
- Intolerance to first-line therapy, as fully assessed by the investigator, may also allow enrollment into the study. Intolerance to prior study treatment is defined as follows:
- Any grade ≥3 hematologic toxicity (per NCI-CTCAE v5.0) that does not recover to grade 1 or pre-treatment level after 14 days of best supportive care; ii. Any grade ≥3 non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) per NCI-CTCAE v5.0 that does not recover to normal after 14 days of best supportive care.
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- Adequate organ and bone marrow function;
- Estimated life expectancy > 3 months;
- Subjects must agree to provide sufficient tumor tissue samples for EGFR and PD-L1 immunohistochemistry (IHC) expression testing, next-generation sequencing (NGS), and multi-omics analysis. This includes archived tumor samples (paraffin blocks or unstained sections meeting the testing requirements specified in the study); if no archived tumor tissue sample is available, the subject agrees to undergo re-biopsy of the tumor lesion.
Who cannot join
- Failure of first-line gemcitabine-based therapy.
- Other histologic types of pancreatic tumors, such as neuroendocrine tumors, acinar cell carcinoma, cystic carcinoma, etc.
- Prior treatment with an MMAE-loaded ADC (antibody-drug conjugate).
- Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).
- Known hypersensitivity to the study drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.
- Occurrence of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) Class ≥2 cardiac insufficiency, or symptomatic congestive heart failure.
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- Vaccination with a live vaccine within 4 weeks before the first dose of study drug. Inactivated virus vaccines for seasonal influenza (administered by injection) are permitted, but live attenuated influenza vaccine administered via the intranasal route is not allowed.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of substance abuse (psychoactive drugs) or drug addiction.
- Pregnant or breastfeeding women.
- Diagnosis of any other malignancy within 5 years before study entry, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma that have been treated with local therapy and cured.
- Presence of any other serious physical or psychiatric illness, or laboratory abnormalities that may increase the risk of study participation, interfere with the study results, or render the patient unsuitable for participation in the opinion of the investigator.
- Note: Subjects with hepatitis B meeting the following criteria may also be enrolled:
- HBV viral load < 1000 copies/mL (<200 IU/mL) before the first dose, and the subject must receive anti-HBV therapy during the entire study treatment period to prevent viral reactivation.
- For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.
- Subjects with active HCV infection (positive HCV antibody and HCV-RNA levels above the lower limit of detection).
- Vaccination with a live vaccine within 30 days before the first dose (Cycle 1, Day 1).
- Note: Inactivated injectable vaccines for seasonal influenza are permitted within 30 days before the first dose; live attenuated influenza vaccine administered intranasally is not allowed.
- Presence of any serious or uncontrolled systemic disease, for example:
- Clinically significant and severe, difficult-to-control abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.
- Unstable angina pectoris, congestive heart failure, or chronic heart failure of NYHA Class ≥2.
- Any arterial thrombotic, embolic, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before study treatment.
- Poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
- Active tuberculosis.
- Active or uncontrolled infection requiring systemic therapy.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.
- Poorly controlled diabetes mellitus (fasting blood glucose > 10 mmol/L).
- Urinalysis showing proteinuria ≥ 2+, with confirmed 24-hour urine protein > 1.0 g.
- Psychiatric disorders that prevent the patient from cooperating with treatment.
- History or evidence of disease, treatment, or laboratory abnormalities that could interfere with the study results or prevent the subject from completing full participation in the study, or any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment, including potential risks that are not explicitly listed above.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-arm, Ib/II Exploratory Study of Becotatugvedotin(MRG003) in Combination With Gemcitabine for Second-line Advanced Pancreatic Ductal Adenocarcinoma
This is a Phase Ib/II clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line pancreatic ductal adenocarcinoma (PDAC). The study plans to enroll 27-30 patients, including 3-6 patients in the first stage (Phase I) and 24 patients in the second stage (Phase II).
The study consists of three periods: screening period (including baseline), treatment period, and follow-up period (safety follow-up and survival follow-up). Eligible patients must have locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology.
Read more
Phase I: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. Becotatugvedotin will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II.
Phase II: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose.
- Being tested
- becotatugvedotin plus gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
becotatugvedotin plus gemcitabineDrug
Phase I: patients will receive treatment with becotatugvedo and gemcitabine. Becotatugvedo will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II.
Phase II: patients will receive treatment with becotatugvedo and gemcitabine. The dose of becotatugvedo will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib: "3+3" Dose Escalation Cohort | Experimental | Becotatugvedo will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II. Receives: Drug: becotatugvedotin plus gemcitabine |
| Phase II: Dose Expansion Cohort | Experimental | Patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose. Receives: Drug: becotatugvedotin plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLTs)
Measured: half a year
Recommended Phase II Dose (RP2D)
Measured: half a year
Progression-Free Survival (PFS)
Measured: 1 year
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: 1 year
Disease Control Rate (DCR)
Measured: 1 year
Overall Survival(OS)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start8 Jun 2026 (estimated)
- Primary completion7 May 2028 (estimated)
- Study completion7 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685470
- Sponsor's protocol ID
- I-26PJ0942
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Ib/II Exploratory Study of Becotatugvedotin(MRG003) in Combination With Gemcitabine for Second-line Advanced Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07685470
- Acronym / sponsor ID
- I-26PJ0942
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 7 May 2028 (estimated)
- Study completion
- 7 Jun 2029 (estimated)
- First posted
- 6 Jul 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.
This is a Phase Ib/II clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line pancreatic ductal adenocarcinoma (PDAC). The study plans to enroll 27-30 patients, including 3-6 patients in the first stage (Phase I) and 24 patients in the second stage (Phase II).
The study consists of three periods: screening period (including baseline), treatment period, and follow-up period (safety follow-up and survival follow-up). Eligible patients must have locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology.
Phase I: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. Becotatugvedotin will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II.
Phase II: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ib: "3+3" Dose Escalation Cohort | Experimental | Drug: becotatugvedotin plus gemcitabineBecotatugvedo will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II. |
| Phase II: Dose Expansion Cohort | Experimental | Drug: becotatugvedotin plus gemcitabinePatients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ECOG performance status score of 0-2;
- Histopathologically confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC);
- Radiographic progression or worsening of clinical symptoms; disease progression occurring within 6 months after completion of neoadjuvant/adjuvant therapy is also considered first-line treatment failure.
- Intolerance to first-line therapy, as fully assessed by the investigator, may also allow enrollment into the study. Intolerance to prior study treatment is defined as follows:
- Any grade ≥3 hematologic toxicity (per NCI-CTCAE v5.0) that does not recover to grade 1 or pre-treatment level after 14 days of best supportive care; ii. Any grade ≥3 non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) per NCI-CTCAE v5.0 that does not recover to normal after 14 days of best supportive care.
Key exclusion criteria (31 listed)
- Failure of first-line gemcitabine-based therapy.
- Other histologic types of pancreatic tumors, such as neuroendocrine tumors, acinar cell carcinoma, cystic carcinoma, etc.
- Prior treatment with an MMAE-loaded ADC (antibody-drug conjugate).
- Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).
- Known hypersensitivity to the study drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.
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 |
|---|---|---|
| becotatugvedotin plus gemcitabinePhase I: patients will receive treatment with becotatugvedo and gemcitabine. Becotatugvedo will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II. Phase II: patients will receive treatment with becotatugvedo and gemcitabine. The dose of becotatugvedo will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). | Drug | Phase II: Dose Expansion Cohort, Phase Ib: "3+3" Dose Escalation Cohort |
Primary outcome
Dose-Limiting Toxicities (DLTs)
Time frame: half a year
Recommended Phase II Dose (RP2D)
Time frame: half a year
Progression-Free Survival (PFS)
Time frame: 1 year
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Overall Survival(OS)
Time frame: 3 year
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 6 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing becotatugvedotin plus gemcitabine in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Second Line Treatment, run by Peking Union Medical College Hospital.
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 9 inclusion and 31 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 XIANG WANG (861069158751, wangxiang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLTs) (time frame: half a year). The study lists 3 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 6 Jul 2026.