InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 7 October 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

Use the hyperlinks, where available to access additional clinical trial information.

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.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Cancer Connect

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Get support

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

More info for carers

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

HelpThis verification step helps prevent fraudulent transactions from automated software.
Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.