Clinical trial · Interventional
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company Strategy
Summary
Brief summary (as posted)
This study is a two stage study consisting of a dose escalation phase Ib and a phase II study which include subjects with previously-treated, advanced pancreatic adenocarcinoma. Dose Limiting Toxicities (DLTs) and maximum tolerated dose (MTD) of APG1387 in combination with nab-paclitaxel and gemcitabine will be evaluated in the dose escalation phase Ib. Safety and efficacy of APG1387 plus gemcitabine and nab-paclitaxel will be evaluated in phase II.
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 |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APG-1387 for Injection | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- APG1387 in combination with Gemcitabine and Nab-Paclitaxel
- interventionNames
- Drug: APG-1387 for Injection
- Drug: Gemcitabine
- Drug: Nab paclitaxel
Primary outcomes (2)
- measure
- Dose Limiting Toxicities (DLT) of combination therapy (Applicable for: phase Ib stage ).
- timeFrame
- 28 days.
- description
- DLT will be graded according to NCI CTCAE Version 5.0. DLT will be defined as clinically significant drug-related adverse events during the cycle one.
- measure
- Overall Response Rate (Applicable for: phase II stage) .
- timeFrame
- Up to 2 years.
- description
- Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must be ≥18 years of age at time of informed consent 2. Able to comply with the study protocol, in the investigator's judgment 3. Expected survival ≥ 3 months 4. Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and: * Standard treatment failed or intolerant to standard treatment(Phase Ib); * First line standard treatment failed (Phase II). 5. ECOG 0-1; 6. Adequate organ function. 7. Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment Exclusion Criteria: 1. Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug. 2. Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug. 3. Has received a therapy with TNFα within 28 days of the first dose of study drug. 4. Known active central nervous system involvement. 5. Has received IAP-inhibitor before. 6. Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days. 7. Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive. 8. Pregnant or breastfeeding (lactating) women. 9. Other situations that investigator think not suit for study.
References
Publications (1)
- DERIVEDShi S, Zhang J, Liu R, Gao S, Xu J, Wang W, Wei M, Li J, Liu C, Xu X, Pan W, Tian X, Men L, Wang H, Liang Z, Zhu M, Yang D, Zhai Y, Yu X. A phase 1 trial of APG-1387, an IAP antagonist, with nab-paclitaxel and gemcitabine in patients with refractory metastatic pancreatic cancer. Cell Rep Med. 2025 Oct 21;6(10):102364. doi: 10.1016/j.xcrm.2025.102364. Epub 2025 Sep 19. PMID 40975066