Advanced Pancreatic CancerPhase 1/2NCT04643405
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
A Phase 1/2 study testing APG-1387 for Injection, Gemcitabine and Nab paclitaxel in people with Advanced Pancreatic Cancer, run by Ascentage Pharma Group Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- APG-1387 for Injection, Gemcitabine and Nab paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2021to 10 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
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.
Read the detailed description
The ability of tumor cells to evade apoptosis is currently a major problem in anti-tumor therapy. IAPs are an important class of apoptosis-regulating proteins. APG-1387, a potent bivalent SMAC mimetic, small molecule of IAP inhibitor, which could inhibit pancreatic cancer proliferation as monotherapy and in combination with chemotherapy through apoptosis pathway.
It's an open label, multiple centers phase Ib/II Study. Safety and tolerability of APG1387 combined with nab-paclitaxel and gemcitabine will be evaluated in phase Ib in previously-treated, advanced pancreatic adenocarcinoma patients. Efficacy and tolerability will be evaluated in phase II study in first line standard treatment failed metastatic pancreatic adenocarcinoma patients.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- APG-1387 for Injection, Gemcitabine, Nab paclitaxel
- Keywords
- IAP inhibitor, APG-1387, Pancreatic cancer, Inhibitor of apoptosis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-1387 for InjectionDrug
APG1387 will be administered IV days 1， 8, 15 and 22 of a 28 day cycle.
GemcitabineDrug
Gemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
Nab paclitaxelDrug
Nab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| APG1387 in combination with Gemcitabine and Nab-Paclitaxel | Experimental | Not described Receives: Drug: APG-1387 for Injection; Drug: Gemcitabine; Drug: Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days.
Overall Response Rate (Applicable for: phase II stage) .
Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: Up to 2 years.
Secondary outcomes (6)
Progression Free Survival (PFS)
From date of treatment start until the date of progression or the date of death due to any cause.
Measured: Up to 2 years.
Duration of Response (DOR)
From date of response until the date of progression.
Measured: Up to 2 years.
Overall Survival (OS)
From date of treatment start until the date of death due to any cause.
Measured: Up to 2 years.
Maximum plasma concentration (Cmax)
Cmax of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study.
Measured: 28 days.
Area under the plasma concentration versus time curve (AUC)
AUC of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study.
Measured: 28 days.
Adverse events
Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0.
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start17 Mar 2021
- Primary completion25 Jun 2024
- Study completion10 Dec 2024
Why it stopped: Company Strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifan Zhai, MD, PhD, Study chair, Jiangsu Ascentage Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643405
- Sponsor's protocol ID
- APG1387PC101
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2020
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40975066
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04643405
- Acronym / sponsor ID
- APG1387PC101
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- IAP inhibitor, APG-1387, Pancreatic cancer, Inhibitor of apoptosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Strategy
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ability of tumor cells to evade apoptosis is currently a major problem in anti-tumor therapy. IAPs are an important class of apoptosis-regulating proteins. APG-1387, a potent bivalent SMAC mimetic, small molecule of IAP inhibitor, which could inhibit pancreatic cancer proliferation as monotherapy and in combination with chemotherapy through apoptosis pathway.
It's an open label, multiple centers phase Ib/II Study. Safety and tolerability of APG1387 combined with nab-paclitaxel and gemcitabine will be evaluated in phase Ib in previously-treated, advanced pancreatic adenocarcinoma patients. Efficacy and tolerability will be evaluated in phase II study in first line standard treatment failed metastatic pancreatic adenocarcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APG1387 in combination with Gemcitabine and Nab-Paclitaxel | Experimental | Drug: APG-1387 for Injection, Drug: Gemcitabine, Drug: Nab paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- ECOG 0-1;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-1387 for InjectionAPG1387 will be administered IV days 1， 8, 15 and 22 of a 28 day cycle. | Drug | APG1387 in combination with Gemcitabine and Nab-Paclitaxel |
| GemcitabineGemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle. | Drug | APG1387 in combination with Gemcitabine and Nab-Paclitaxel |
| Nab paclitaxelNab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle. | Drug | APG1387 in combination with Gemcitabine and Nab-Paclitaxel |
Primary outcome
Dose Limiting Toxicities (DLT) of combination therapy (Applicable for: phase Ib stage ).
Time frame: 28 days.
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.
Overall Response Rate (Applicable for: phase II stage) .
Time frame: Up to 2 years.
Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 2 years.
Duration of Response (DOR)
Time frame: Up to 2 years.
Overall Survival (OS)
Time frame: Up to 2 years.
Maximum plasma concentration (Cmax)
Time frame: 28 days.
Area under the plasma concentration versus time curve (AUC)
Time frame: 28 days.
Adverse events
Time frame: Up to 2 years.
Results and safety
The study was stopped early (reason given: Company Strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 40975066Shi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yifan Zhai, MD, PhD study chair
Jiangsu Ascentage Pharma Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APG-1387 for Injection, Gemcitabine and Nab paclitaxel in people with Advanced Pancreatic Cancer, run by Ascentage Pharma Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company Strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) of combination therapy (Applicable for: phase Ib stage ). (time frame: 28 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.