Clinical trial · Interventional
A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence. Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPI-926 plus gemcitabine | Drug | — | UNRESOLVED |
| Placebo plus gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 (Phase 2)
- description
- IPI-926 in combination with gemcitabine
- interventionNames
- Drug: IPI-926 plus gemcitabine
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 (Phase 2)
- description
- Placebo in combination with gemcitabine
- interventionNames
- Drug: IPI-926 plus gemcitabine
- Drug: Placebo plus gemcitabine
Primary outcomes (2)
- measure
- Evaluation of safety profile including MTD
- timeFrame
- Once per week for 3 weeks of a 4 week cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age * Pathologically confirmed metastatic pancreatic adenocarcinoma * At least 1 radiologically evaluable metastatic lesion (RECIST 1.1). * ECOG 0 or 1 * Life expectancy ≥3 months. * All women of child bearing potential, all sexually active male patients, and partners of patients must agree to use adequate methods of birth control * Ability to adhere to the study visit schedule * Voluntarily signed an informed consent form Exclusion Criteria: * Islet cell, acinar cell carcinoma, non-adenocarcinoma, (i.e., lymphoma, sarcoma), adenocarcinoma originated from biliary tree or cystadenocarcinoma * Prior treatment with chemotherapy for pancreatic cancer. * Known central nervous system metastases * Inadequate hematologic function * Inadequate hepatic function * Inadequate renal function * External (percutaneous) biliary drain * History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months. * Venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation not appropriately anticoagulated or have NCI CTCAE Grade 2 or greater bleeding episode in the 3 weeks prior to administration of IPI-926 * Concurrent administration of the medications or foods known to inhibit CYP3A activity to a clinically relevant degree * Presence of active infection or systemic use of antibiotics within 72 hours of treatment * Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study. * Known human immunodeficiency virus (HIV) positivity * Known hypersensitivity to gemcitabine, IPI-926, or their excipients * Pregnant or lactating women
References
Publications (1)
- DERIVEDKochetkova M, Samuel MS. Differentiation of the tumor microenvironment: are CAFs the Organizer? Trends Cell Biol. 2022 Apr;32(4):285-294. doi: 10.1016/j.tcb.2021.11.008. Epub 2021 Dec 9. PMID 34895986