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RecruitingLast updated: 19 April 2024

M20-732: This Phase II trial is evaluating how safe and effective a targeted therapy (ABBV-927) is when combined with chemotherapy (mFFX) both with or without another targeted therapy (budigalimab), compared to mFFX alone, in adults with untreated metastatic pancreatic cancerA Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma

Clinical summary

Summary

This randomised, open-label trial has two phases. In the first phase (dose escalation), participants will receive escalating doses of ABBV-927 (administered intravenously [IV]), in combination with modified FOLFIRINOX (mFFX) (IV) and budigalimab (IV). The second phase has three cohorts. In Phase 2 Cohort A, participants will receive mFFX (via IV) monotherapy, on Day 1 and Day 15 of each 28 day cycle. In Phase 2 Cohort B, participants will receive mFFX (via IV) on Day 1 and Day 15, in combination with ABBV-927 (via IV) in each 28 day cycle. In Phase 2 Cohort C Expansion, participants will receive mFFX (via IV) on Day 1 and Day 15, in combination with ABBV-927 (via IV) and budigalimab (via IV) in each 28 day cycle.

Conditions

This trial is treating patients with pancreatic cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 75

Phase

II

Trial Acronym

M20-732

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma

Eligibility

Inclusion

  • Body weight >= 35 kg.
  • Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
  • Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
  • Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.

Exclusion

  • Participants with locally advanced disease.
  • Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
  • Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
  • Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
  • Prior radiotherapy to any measurable metastatic lesion at any time.
  • Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
  • Known metastases to the central nervous system (CNS).

Inclusion

  • Your cancer has spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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