Advanced Solid TumorPhase 1NCT05837299
A Study of IMC008 for Advanced Solid Tumors
A Phase 1 study testing IMC008 in people with Advanced Solid Tumor, run by Changhai Hospital at 1 site in China.
Trial summary
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- IMC008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2023to 31 Mar 2026
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
- Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
- The expected survival period of the subject is ≥12 weeks.
- The subject needs to have at least one target lesion that can be stably evaluated.
- The ECOG score is 0-1.
- Subject has adequate organ and bone marrow function
Show all 9Show fewer
- All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1.
- Fertility status : Women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures.
- Subjects must sign and date written informed consent.
Who cannot join
- Pregnant and lactating women.
- Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
- Serious infection that is active or poorly controlled clinically.
- Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
- Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
- Oxygen saturation ≤ 95% without oxygen inhalation.
Show all 17Show fewer
- Suffering from other research diseases that may limit their participation in this study.
- Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease.
- There are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus.
- Presence of any cardiac clinical symptoms or disorders.
- Evidence of significant coagulopathy or other significant bleeding risk.
- Received systemic steroids equivalent to >15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids.
- Prior or concurrent occurrence of other malignancies, with the following exceptions.
- Subjects who have previously received other gene therapy.
- Allergic/ intolerance to lymphodepletion regimen or CRS treatment drugs or IMC008.
- Subjects with severe mental disorders.
- The investigator assessed the subject's inability or unwillingness to comply with the requirements of the study protocol .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhengmao Lu, MD, 86-21-13564524664, luzhengmao82@126.com
About this study
Official title: A Clinical Study on the Safety and Preliminary Efficacy of IMC008 in the Treatment of CLDN18.2- Positive Advanced Solid Tumors
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
Read the detailed description
This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.
- Conditions
- Advanced Solid Tumor
- Being tested
- IMC008
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC008Drug
Also called NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2
allowing 10% dose error
| Study group | Role | What they receive |
|---|---|---|
| IMC008 dose 1-3 | Experimental | a certain number of IMC008 cell per kg will be infused Receives: Drug: IMC008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
To observe the incidence of dose-limiting toxicity (DLT) after IMC008 infusion
Measured: within 28 days
Secondary outcomes (6)
TRAE
To treatment-related adverse events (TRAE) and severity
Measured: up to 96 weeks
PFS
To evaluate the progression-free survival of IMC008 in patients with CLDN18.2 positive advanced solid tumor
Measured: upto 96 weeks
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Measured: upto 96 weeks
Tmax
Tmax of CAR-T cells in the blood.
Measured: upto 96 weeks
Lymphocyte subsets
CAR-T cell lymphocyte subsets/phenotype, etc.
Measured: upto 96 weeks
OS
To evaluate the overall survival of of IMC008 in patients with CLDN18.2 positive advanced solid tumor
Measured: upto 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start2 Apr 2023
- 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 Advanced Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose escalation of 3 dosage groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Tianhang, Changhai Hospital
- Investigators
- Tianhang Luo, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837299
- Sponsor's protocol ID
- IMC008-CT01
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Preliminary Efficacy of IMC008 in the Treatment of CLDN18.2- Positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05837299
- Acronym / sponsor ID
- IMC008-CT01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 1 May 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.
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
Detailed description
This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation of 3 dosage groups
| Arm | Type | Receives |
|---|---|---|
| IMC008 dose 1-3 | Experimental | Drug: IMC008a certain number of IMC008 cell per kg will be infused |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
- Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
- The expected survival period of the subject is ≥12 weeks.
- The subject needs to have at least one target lesion that can be stably evaluated.
- The ECOG score is 0-1.
Key exclusion criteria (17 listed)
- Pregnant and lactating women.
- Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
- Serious infection that is active or poorly controlled clinically.
- Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
- Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
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 |
|---|---|---|
| IMC008Also: NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2allowing 10% dose error | Drug | IMC008 dose 1-3 |
Primary outcome
DLT
Time frame: within 28 days
To observe the incidence of dose-limiting toxicity (DLT) after IMC008 infusion
6 secondary outcomes
TRAE
Time frame: up to 96 weeks
PFS
Time frame: upto 96 weeks
Objective response rate (ORR)
Time frame: upto 96 weeks
Tmax
Time frame: upto 96 weeks
Lymphocyte subsets
Time frame: upto 96 weeks
OS
Time frame: upto 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingPhase 1
Study of SC-102 in Patients With Advanced Solid Tumors
Advanced Solid Cancers
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
Advanced Solid Tumors, Malignant Neoplasm
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.
Tianhang Luo, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMC008 in people with Advanced Solid Tumor, run by Changhai Hospital 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 17 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: status not confirmed, as of the sponsor's last update on 1 May 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianhang Luo, MD (8613816977973, luotianhang78@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: within 28 days). 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 1 May 2023.