Advanced Pancreatic CancerPhase 1/2NCT06821503
Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C
A Phase 1/2 study testing LM-108 injection, Penpulimab injection and Paclitaxel for injection (albumin bound) in people with Advanced Pancreatic Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
Trial summary
This trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. 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?
- LM-108 injection, Penpulimab injection and Paclitaxel for injection (albumin bound)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 16 sitesChina
- Study dates
- 11 Apr 2025to Dec 2028
- 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
- Age 18 or above.
- The Eastern Cooperative Oncology Group (ECOG) physical fitness status score is 0-1 points.
- There should be at least one measurable lesion.
- All acute toxic reactions caused by previous anti-tumor treatments or surgical procedures have been relieved to grade 0-1 or to the levels specified in the inclusion/exclusion criteria.
- Have sufficient organ and bone marrow function
- Expected survival period ≥ 12 weeks
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- Infertility is defined as women who have reached menopause or have undergone bilateral oophorectomy with medical records. Male participants and female participants with fertility must agree to use one medically approved contraceptive measure during the trial period and within 6 months after the last administration of the trial drug or within 9 months after the last administration of chemotherapy drug (oxaliplatin) (whichever is later). The serum pregnancy test must be negative within 3 days before starting the study medication and not during lactation.
- With my consent and signed informed consent form.
- Patients with a pathological diagnosis of pancreatic cancer (ductal adenocarcinoma or adenocarcinoma) have evidence of advanced or metastatic disease that is not resectable.
- Previously received no systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
Who cannot join
- Known High-frequency microsatellite instability (MSI-H)/deficient mismatch repair (dMMR).
- There is uncontrolled or symptomatic active central nervous system metastasis, which can manifest as clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth.
- Within 14 days prior to enrollment, there were still uncontrollable pleural effusion and ascites despite treatment such as puncture and drainage; Pericardial effusion accompanied by clinical symptoms or moderate or above.
- Within 14 days prior to enrollment, there is an unresolved biliary obstruction, or the clinical status has remained stable for less than 14 days after biliary stent implantation.
- Participants' weight has decreased by more than 20% or their body mass index (BMI) is less than 18 kg/m ² within the first 2 months of enrollment.
- Received the following treatments or medications before enrollment:
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- Prior to enrollment, received treatment with C-C chemokine Receptor 8 (CCR8) antibodies, cytotoxic T-lymphocyte associated protein-4 (CTLA-4) antibodies, or other drugs that act on Tregs.
- Having undergone major surgery within 28 days prior to enrollment.
- Used immunosuppressive drugs within 14 days prior to enrollment.
- Vaccination with attenuated live vaccine should be administered within 28 days prior to enrollment or planned within the study period and 60 days after completion of study drug treatment.
- Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days before enrollment.
- Diagnosed with any other malignant tumor within the 5 years prior to enrollment.
- There are any active, known or suspected autoimmune diseases present.
- Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; Arterial/venous thrombotic events that occurred within the first 6 months of enrollment.
- Significant vascular disease occurred within the first 6 months of enrollment.
- Severe, unhealed, or cracked wounds, as well as active ulcers or untreated fractures.
- There is peripheral neuropathy of grade>1 present.
- Have experienced gastrointestinal perforation and/or gastrointestinal fistula within the 6 months prior to enrollment;
- Within the 6 months prior to enrollment, there have been clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction.
- Existence of interstitial lung disease, non infectious pneumonia, or uncontrolled systemic diseases.
- Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis or co infection with hepatitis B and hepatitis C.
- Clinical symptoms or diseases of the heart that have not been well controlled:
- Systemic use of antibiotics for at least 7 days within the 28 days prior to enrollment, or unexplained fever>38.5 °C during screening/before first administration.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Have participated in any other drug clinical studies within 4 weeks prior to enrollment, or have not had more than 5 half lives since the last study medication.
- Known history of abuse or drug use of psychotropic substances.
- There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients who the researcher deems unsuitable to participate in this study.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Xicheng Wang, Doctor, 13439563949, xicheng_wang@hotmail.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Yongkun Sun, Doctor, 13141276041, hsunyk@126.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Doctor, 010-88196561, doctorshenlin@sina.cn
- Not yet recruiting
Chongqing Qeneral Hospital
Chongqing, Chongqing Municipality, 400013
Huaizhi Wang, Doctor, 13996950719, whuaizhi@qq.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Zhiwei Li, Doctor, 15004683651, lzhw0451@163.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yong Li, Doctor, 15879155066, liyong1553@163.com
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Xiaofeng Sun, Master, 13505156959, jssxfgcp@163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Kuirong Jiang, Doctor, 15312995688, jiangkuirong@163.com
- Not yet recruiting
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200336
Gang Jin, Doctor, 13601635681, Jigang@sohu.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
Xiujuan Qu, Doctor, 13604031355, qu_xiujuan@hotmail.com
- Not yet recruiting
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110002
Jin Xu, Doctor, 13236666950, xvjin2024@sina.com
- Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300000
Huikai Li, Doctor, 18622228639, tjchlhk@126.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Jihui Hao, Doctor, 18622221120, haojihui@tjmuch.com
- Not yet recruiting
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Jun Xue, Doctor, 15071258754, xjunion@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an, Shaanxi, 710000
Zheng Wu, Doctor, 13609195898, woozheng@xjtu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Feng Wang, Doctor, 13938244776, fengw010@163.com
Aili Suo Suo, Doctor, 18991232561, Ailisuo@mail.xjtu.edu.cn
About this study
Official title: An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C
This trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. The dose of LM-108 combined with penpulimab, albumin paclitaxel, and gemcitabine is recommended in Phase Ib.Explore the efficacy and safety of LM-108 combined with anti-tumor therapy in patients with advanced pancreatic cancer in Phase II.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- LM-108 injection, Penpulimab injection, Paclitaxel for injection (albumin bound), Gemcitabine hydrochloride for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-108 injectionDrug
LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Penpulimab injectionDrug
Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
Paclitaxel for injection (albumin bound)Drug
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
Gemcitabine hydrochloride for injectionDrug
Gemcitabine hydrochloride for injection is a cell cycle specific anti-tumor drug that can inhibit the growth of tumor cells and belongs to a type of chemotherapy drug.
| Study group | Role | What they receive |
|---|---|---|
| LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine | Experimental | LM-108 injection+Penpulimab injection+Paclitaxel for injection (albumin bound)+Gemcitabine hydrochloride for injection, with a cycle of 28 days. Receives: Drug: LM-108 injection; Drug: Penpulimab injection; Drug: Paclitaxel for injection (albumin bound); Drug: Gemcitabine hydrochloride for injection |
| LM-108 injection+Albumin paclitaxel+Gemcitabine | Experimental | LM-108 injection+paclitaxel for injection (albumin bound type)+gemcitabine hydrochloride for injection, with a cycle of 28 days. Receives: Drug: LM-108 injection; Drug: Paclitaxel for injection (albumin bound); Drug: Gemcitabine hydrochloride for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Measured: Baseline up to 28 days
Progression-Free Survival (PFS)
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
Measured: Up to 48 weeks
Secondary outcomes (3)
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Measured: Up to 96 weeks
Duration of Response (DOR)
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Measured: Up to 48 weeks
Overall response rate (ORR)
Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST 1.1 for immune based therapeutics(iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start11 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821503
- Sponsor's protocol ID
- LM-108-Ib/II-01-C
- Status last verified
- Dec 2025
- First submitted
- 21 Jan 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C
- ClinicalTrials.gov ID
- NCT06821503
- Acronym / sponsor ID
- LM-108-Ib/II-01-C
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Feb 2025 (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 trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. The dose of LM-108 combined with penpulimab, albumin paclitaxel, and gemcitabine is recommended in Phase Ib.Explore the efficacy and safety of LM-108 combined with anti-tumor therapy in patients with advanced pancreatic cancer in Phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine | Experimental | Drug: LM-108 injection, Drug: Penpulimab injection, Drug: Paclitaxel for injection (albumin bound), Drug: Gemcitabine hydrochloride for injectionLM-108 injection+Penpulimab injection+Paclitaxel for injection (albumin bound)+Gemcitabine hydrochloride for injection, with a cycle of 28 days. |
| LM-108 injection+Albumin paclitaxel+Gemcitabine | Experimental | Drug: LM-108 injection, Drug: Paclitaxel for injection (albumin bound), Drug: Gemcitabine hydrochloride for injectionLM-108 injection+paclitaxel for injection (albumin bound type)+gemcitabine hydrochloride for injection, with a cycle of 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or above.
- The Eastern Cooperative Oncology Group (ECOG) physical fitness status score is 0-1 points.
- There should be at least one measurable lesion.
- All acute toxic reactions caused by previous anti-tumor treatments or surgical procedures have been relieved to grade 0-1 or to the levels specified in the inclusion/exclusion criteria.
- Have sufficient organ and bone marrow function
Key exclusion criteria (28 listed)
- Known High-frequency microsatellite instability (MSI-H)/deficient mismatch repair (dMMR).
- There is uncontrolled or symptomatic active central nervous system metastasis, which can manifest as clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth.
- Within 14 days prior to enrollment, there were still uncontrollable pleural effusion and ascites despite treatment such as puncture and drainage; Pericardial effusion accompanied by clinical symptoms or moderate or above.
- Within 14 days prior to enrollment, there is an unresolved biliary obstruction, or the clinical status has remained stable for less than 14 days after biliary stent implantation.
- Participants' weight has decreased by more than 20% or their body mass index (BMI) is less than 18 kg/m ² within the first 2 months of enrollment.
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 |
|---|---|---|
| LM-108 injectionLM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. | Drug | LM-108 injection+Albumin paclitaxel+Gemcitabine, LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine |
| Penpulimab injectionPenpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor. | Drug | LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine |
| Paclitaxel for injection (albumin bound)Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug | Drug | LM-108 injection+Albumin paclitaxel+Gemcitabine, LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine |
| Gemcitabine hydrochloride for injectionGemcitabine hydrochloride for injection is a cell cycle specific anti-tumor drug that can inhibit the growth of tumor cells and belongs to a type of chemotherapy drug. | Drug | LM-108 injection+Albumin paclitaxel+Gemcitabine, LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Progression-Free Survival (PFS)
Time frame: Up to 48 weeks
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
3 secondary outcomes
Overall survival (OS)
Time frame: Up to 96 weeks
Duration of Response (DOR)
Time frame: Up to 48 weeks
Overall response rate (ORR)
Time frame: Up to 48 weeks
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 10 Mar 2026.
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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.
16 sites 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 LM-108 injection, Penpulimab injection and Paclitaxel for injection (albumin bound) in people with Advanced Pancreatic Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites 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 10 inclusion and 28 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 Lin Shen, Doctor (13911219511, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Baseline up to 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?
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 10 Mar 2026.