APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

NCT04643405 | Terminated Phase 1

• 1 other identifier: APG1387PC101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Pancreatic Cancer

Keywords

IAP inhibitor; APG-1387; Pancreatic cancer; Inhibitor of apoptosis

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities (DLT) of combination therapy (Applicable for: phase Ib stage ).

  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.

  28 days.

• Overall Response Rate (Applicable for: phase II stage) .

  Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  Up to 2 years.

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Up to 2 years.

• Duration of Response (DOR)

  Up to 2 years.

• Overall Survival (OS)

  Up to 2 years.

• Maximum plasma concentration (Cmax)

  28 days.

• Area under the plasma concentration versus time curve (AUC)

  28 days.

Study Arms (1)

APG1387 in combination with Gemcitabine and Nab-Paclitaxel

EXPERIMENTAL

Drug: APG-1387 for Injection; Drug: Gemcitabine; Drug: Nab paclitaxel

Interventions

APG-1387 for Injection DRUG

APG1387 will be administered IV days 1， 8, 15 and 22 of a 28 day cycle.

APG1387 in combination with Gemcitabine and Nab-Paclitaxel

Gemcitabine DRUG

Gemcitabine 1000 mg/m\^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.

APG1387 in combination with Gemcitabine and Nab-Paclitaxel

Nab paclitaxel DRUG

Nab-Paclitaxel 125mg/m\^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.

APG1387 in combination with Gemcitabine and Nab-Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be ≥18 years of age at time of informed consent
• Able to comply with the study protocol, in the investigator's judgment
• Expected survival ≥ 3 months
• 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).
• ECOG 0-1;
• Adequate organ function.
• Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment

You may not qualify if:

• Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug.
• Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
• Has received a therapy with TNFα within 28 days of the first dose of study drug.
• Known active central nervous system involvement.
• Has received IAP-inhibitor before.
• Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days.
• Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive.
• Pregnant or breastfeeding (lactating) women.
• Other situations that investigator think not suit for study.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Shi 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

APG-1387; Injections; Gemcitabine; Taxes

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations

Study Officials

• Yifan Zhai, MD, PhD

  Jiangsu Ascentage Pharma Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: March 17, 2021
• Primary Completion: June 25, 2024
• Study Completion: December 10, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (1)