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MRG003 With Gemcitabine for Second-line Advanced PDAC

NCT07685470 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-06

No results posted yet for this study

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 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.

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Second Line Treatment

Interventions

DRUG

becotatugvedotin plus gemcitabine

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).

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2028-05-07
Completion
2029-06-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685470 on ClinicalTrials.gov