Pancreatic CancerPhase 1/2NCT05827796
IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
A Phase 1/2 study testing IN10018, Albumin-Bound Paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by InxMed (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel +… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- IN10018, Albumin-Bound Paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2022to 31 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form.
- Female or male subjects ≥ 18 years at the time of signing informed consent.
- Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
- No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer.
- At least one measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Life expectancy of at least 3 months as assessed by the investigator.
- Must have recovered from all AEs due to previous anticancer therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by the investigator. Subjects with any grade of alopecia and grade 2 peripheral neuropathy could be enrolled.
- Adequate bone marrow, liver, renal, and coagulation function .
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) . or
- A WOCBP who agrees to follow the contraceptive guidance.
Who cannot join
- Has had major surgery or major trauma within 28 days prior to the first dose of study treatment.
- Has known BRCA1/2 mutations.
- Has received prior systemic anticancer therapy including chemotherapy, targeted therapy, immunotherapy, unmarketed investigational drugs or therapy within 28 days prior to the first dose of study treatment.
- Previous anti-programmed death 1(PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or checkpoint pathways, or prior treatment with focal adhesion kinase (FAK) inhibitors.
- Has received radical radiotherapy within 3 months prior to the first dose of study treatment. Subjects who have received palliative radiotherapy with a local standardized dose within 2 weeks prior to the first dose of study treatment.
- Has received previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
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- Has received live vaccines and live attenuated vaccines within 28 days prior to the first dose of study treatment.
- Has interstitial pneumonia or lung disease.
- History or current active autoimmune diseases.
- Has a prior history of other malignancy, other than cured cutaneous squamous cell carcinoma, basal cell cancer, non-basal invasive bladder cancer, and prostate/cervical/breast cancer in situ within 5 years prior to the first dose of study treatment.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases within 6 months before the first dose of study treatment.
- Active infection with poor systemic treatment control.
- Has known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C (HCV) infection, or active syphilis and tuberculosis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Liwei Wang, +86 13761254228, lwwang2013@163.com
About this study
Official title: A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer
This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
Read the detailed description
This is a multicenter, open-label, single-arm, phase Ib/II clinical study to evaluate the safety, tolerability, and antitumor activities of IN10018 + standard chemotherapy (albumin paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer.
This study includes two cohorts, Cohort 1: IN10018 + standard chemotherapy; Cohort 2: IN10018 + standard chemotherapy + KN046. Each cohort consists of 2 phases: a dose confirmation phase and a dose expansion phase. The dose confirmation phase aims to determine recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
According to the Package Insert of standard chemotherapy (albumin paclitaxel and gemcitabine), the Investigator's Brochure (IB) and drug characteristics of KN046, it is expected that IN10018 has little possibility of interaction with standard chemotherapy and KN046, and the safety characteristics are clearly non-overlapping. The therapeutic dose of KN046, albumin-bound paclitaxel and gemcitabine are fixed in this study. In the dose confirmation phase, IN10018 dose will be modified according to the causality between dose-limiting toxicities (DLTs) and IN10018.
- Conditions
- Pancreatic Cancer
- Being tested
- IN10018, Albumin-Bound Paclitaxel, Gemcitabine, KN046
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN10018Drug
Also called BI853520
IN10018 orally once daily at approximately the same time each day, to ensure a dosing interval of approximately 24 hours.
Albumin-Bound PaclitaxelDrug
Albumin-bound paclitaxel will be administered as per the schedule specified in the respective arm.
GemcitabineDrug
Gemcitabine will be administered as per the schedule specified in the respective arm.
KN046Drug
KN046 5 mg/kg on Day 1 of each 21-Day Cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) | Experimental | Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle. Receives: Drug: IN10018; Drug: Albumin-Bound Paclitaxel; Drug: Gemcitabine |
| Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046 | Experimental | Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 2 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 2 and 9 of each 21-Day Cycle+KN046 5 mg/kg IV infusion on Day 1 of each 21-Day Cycle. Receives: Drug: IN10018; Drug: Albumin-Bound Paclitaxel; Drug: Gemcitabine; Drug: KN046 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events （AEs）
Incidence and severity of AEs, with severity determined according to the NationalCancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Measured: 1 year
To evaluate the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in subjects with advanced pancreatic cancer.
Proportion of subjects who have the best objective response of either complete response (CR) or partial response (PR), as assessed by the investigator.
Measured: 2 years
Secondary outcomes (5)
Disease Control Rate (DCR) per RECIST 1.1, as evaluated by investigators
Proportion of subjects who have CR, PR, or stable disease (SD).
Measured: 1 year
duration of response (DoR) per RECIST 1.1, as evaluated by investigators
Available for subjects who demonstrate CR or PR, DoR is defined as the time from the first evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by the investigator.
Measured: 1 years
Progression free survival (PFS) per RECIST 1.1, as evaluated by investigators
Defined as the time from the first day of study treatment to the first disease progression or death due to any cause, whichever occurs first.
Measured: 1 years
Overall survival (OS)
Defined as the time from the first day of study treatment to death due to any cause.
Measured: 2 years
Incidence of Treatment-Related AEs
Incidence and severity of AEs, with severity determined according to the NCI CTCAE v5.0
Measured: 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 Apr 2023
- Study start8 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liwei Wang, Principal investigator, Renji Hospital of Shanghai Jiaotong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827796
- Sponsor's protocol ID
- IN10018-012
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05827796
- Acronym / sponsor ID
- IN10018-012
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Apr 2023 (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 multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
Detailed description
This is a multicenter, open-label, single-arm, phase Ib/II clinical study to evaluate the safety, tolerability, and antitumor activities of IN10018 + standard chemotherapy (albumin paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer.
This study includes two cohorts, Cohort 1: IN10018 + standard chemotherapy; Cohort 2: IN10018 + standard chemotherapy + KN046. Each cohort consists of 2 phases: a dose confirmation phase and a dose expansion phase. The dose confirmation phase aims to determine recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
According to the Package Insert of standard chemotherapy (albumin paclitaxel and gemcitabine), the Investigator's Brochure (IB) and drug characteristics of KN046, it is expected that IN10018 has little possibility of interaction with standard chemotherapy and KN046, and the safety characteristics are clearly non-overlapping. The therapeutic dose of KN046, albumin-bound paclitaxel and gemcitabine are fixed in this study. In the dose confirmation phase, IN10018 dose will be modified according to the causality between dose-limiting toxicities (DLTs) and IN10018.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) | Experimental | Drug: IN10018, Drug: Albumin-Bound Paclitaxel, Drug: GemcitabineSubjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle. |
| Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046 | Experimental | Drug: IN10018, Drug: Albumin-Bound Paclitaxel, Drug: Gemcitabine, Drug: KN046Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 2 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 2 and 9 of each 21-Day Cycle+KN046 5 mg/kg IV infusion on Day 1 of each 21-Day Cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form.
- Female or male subjects ≥ 18 years at the time of signing informed consent.
- Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
- No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer.
- At least one measurable lesion per RECIST 1.1.
Key exclusion criteria (15 listed)
- Has had major surgery or major trauma within 28 days prior to the first dose of study treatment.
- Has known BRCA1/2 mutations.
- Has received prior systemic anticancer therapy including chemotherapy, targeted therapy, immunotherapy, unmarketed investigational drugs or therapy within 28 days prior to the first dose of study treatment.
- Previous anti-programmed death 1(PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or checkpoint pathways, or prior treatment with focal adhesion kinase (FAK) inhibitors.
- Has received radical radiotherapy within 3 months prior to the first dose of study treatment. Subjects who have received palliative radiotherapy with a local standardized dose within 2 weeks prior to the first dose of study treatment.
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 |
|---|---|---|
| IN10018Also: BI853520IN10018 orally once daily at approximately the same time each day, to ensure a dosing interval of approximately 24 hours. | Drug | Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine), Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046 |
| Albumin-Bound PaclitaxelAlbumin-bound paclitaxel will be administered as per the schedule specified in the respective arm. | Drug | Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine), Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046 |
| GemcitabineGemcitabine will be administered as per the schedule specified in the respective arm. | Drug | Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine), Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046 |
| KN046KN046 5 mg/kg on Day 1 of each 21-Day Cycle. | Drug | Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046 |
Primary outcome
Incidence of Treatment-Related Adverse Events （AEs）
Time frame: 1 year
Incidence and severity of AEs, with severity determined according to the NationalCancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
To evaluate the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in subjects with advanced pancreatic cancer.
Time frame: 2 years
Proportion of subjects who have the best objective response of either complete response (CR) or partial response (PR), as assessed by the investigator.
5 secondary outcomes
Disease Control Rate (DCR) per RECIST 1.1, as evaluated by investigators
Time frame: 1 year
duration of response (DoR) per RECIST 1.1, as evaluated by investigators
Time frame: 1 years
Progression free survival (PFS) per RECIST 1.1, as evaluated by investigators
Time frame: 1 years
Overall survival (OS)
Time frame: 2 years
Incidence of Treatment-Related AEs
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Liwei Wang principal investigator
Renji Hospital of Shanghai Jiaotong University of Medicine
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 IN10018, Albumin-Bound Paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by InxMed (Shanghai) Co., Ltd. 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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bohong Zhang (+86 18801955197, bohong.zhang@inxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events （AEs） (time frame: 1 year). 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?
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 30 Apr 2025.