Combining APG-1387 with chemotherapy for advanced pancreatic cancer

An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

This study is testing if a new drug called APG-1387, when combined with chemotherapy, can help people with advanced pancreatic cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04643405 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of APG-1387, an IAP inhibitor, in combination with chemotherapy agents nab-paclitaxel and gemcitabine for patients with advanced pancreatic adenocarcinoma. The study consists of a dose escalation phase Ib to determine the maximum tolerated dose and a phase II to assess the treatment's effectiveness in patients who have failed standard therapies. Participants will be monitored for dose-limiting toxicities and overall response to the treatment regimen. The trial aims to address the challenge of tumor cells evading apoptosis, a significant hurdle in cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced pancreatic adenocarcinoma who have failed or are intolerant to standard treatments.

Not a fit: Patients with active central nervous system involvement or those who have received recent antitumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer who have not responded to standard treatments.

How similar studies have performed: While the use of IAP inhibitors in combination with chemotherapy is a novel approach, similar studies have shown promise in targeting apoptosis pathways in cancer treatment.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xianjun Yu, MD

Conditions Advanced Pancreatic Cancer; IAP inhibitor; APG-1387; Pancreatic cancer; Inhibitor of apoptosis