Malignant NeoplasmsPhase 1NCT04343859

A Study of IMMH-010 in Patients With Advanced Malignant Solid Tumors

A Phase 1 study testing IMMH-010 in people with Malignant Neoplasms, run by Tianjin Chasesun Pharmaceutical Co., LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Phase I study of IMMH-010 in patients with advanced malignant solid tumors Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Neoplasms
What is being tested?: IMMH-010
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteChina
Study dates: 14 May 2020to Dec 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects are eligible only if they meet all the following criteria:
Age ≥ 18 years when they sign the informed consent form;
Patients with advanced or metastatic solid tumors that are confirmed by cytological or histological examination, who did not respond to standard treatment regimens, or did not tolerate these regimens, or had no effective standard treatment regimens, or refused standard treatment regimens;
The ECOG score is 0 or 1 point (see the scoring criteria in Appendix 1);
Based on RECIST 1.1 (see the scoring criteria in Appendix 4), Subjects in Part B study must have at least one measurable lesion, and subjects in Part A study may have no measurable lesion;
Definition of measurable lesion:

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Tumor lesion: The size must be accurately measurable on two mutually perpendicular diameters, and both diameters must be ≥10 mm or ≥2 times of the slice thickness
Lymph node lesion: The size must be accurately measurable on two mutually perpendicular diameters, and both diameters must be ≥15 mm or ≥2 times of the slice thickness
In subjects who had received other treatments, the toxic and side effects should return to grade ≤ 1 or to the baseline (NCI-CTCAE 5.0, excluding alopecia);
The expected survival time should be at least 3 months;
Subjects should have appropriate organ and bone marrow functions, and have laboratory test results within the following ranges before entering the group:
Bone marrow reserve (within 14 days, no transfusion of blood or blood products, or no correction by G-CSF or other hematopoietic stimulate factors): absolute neutrophils count (ANC) ≥1.5×109/L; hemoglobin (HB) ≥90 g/L; and platelet (PLT) ≥75×109/L; Liver function: ALT≤2.5×ULN; AST≤2.5×ULN; ALP≤2.5×ULN; TBIL≤1.5×ULN (patients with known Gilbert's disease are eligible if their serum bilirubin level ≤3×ULN; and patients with metastases to liver are eligible if their ALT≤5×ULN, AST≤5×ULN, and ALP≤5×ULN); and albumin ≥3 g/dL; Kidney function: creatinine ≤1.5×ULN or creatinine clearance ≥45 mL/min as calculated according to Cockcroft-Gault formula (refer to Appendix 2); Blood coagulation function: INR, PT, and APTT≤1.5×ULN (in patients not on anticoagulants; and it is decided by investigators whether patients on anticoagulants are eligible); Cardiac enzymes CK and CKMB measures are not exceeding the upper limit of normal value; Thyroid function measures are within the normal range or mildly abnormal but requiring no treatment.
Fertile eligible patients (males and females) must give their consent to taking reliable contraceptive measures (hormone, barrier, or sexual abstinence) throughout the trial and at least 4 months after the last dosing; reproductive-age females must have negative blood or urine pregnancy test within 21 days prior to initial dosing;
The subjects must give their informed consent for the study and signed ICF voluntarily before the trial;
The subjects or the statutory agents should be able to communicate well and complete the study complying with the protocol.

Who cannot join

Subjects are excluded if they meet one of the following exclusion criteria.
Subjects with a past history of pulmonary fibrosis or interstitial pneumonia, including pneumoconiosis or radiation fibrosis of lung beyond the exposure field, which is clinically significant as judged by the investigators;
Subjects who have received systemic glucocorticoid or any immunosuppressive agents for some condition within 14 days prior to the initial dosing, excluding local glucocorticoid via nose spray, aspiration, or other route, or systemic glucocorticoid at a physiological dose (namely not exceeding 10 mg/d of prednisone or an equivalent dose of other glucocorticoids); corticosteroids are allowed in subjects for pretreatment for venous contrast agent allergic reaction (scanning-relevant) in the study period, but it should be recorded.
Subjects who are expected to receive other systemic antineoplastic treatments in the study period;
Subjects with risks of intestinal obstruction or intestinal perforation, such as a history of diverticulitis, intra-abdominal abscess, active ulcer, GI tract obstruction, or abdominal cancer;
Subjects who are diagnosed with other malignant tumors within 5 years prior to the initial dosing, excluding eradicated basal cell carcinoma of skin, squamous cell carcinoma of skin, and / or radically resected in situ cancer;

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Subjects who ever received any organ transplants, including allogeneic stem cell transplantation, but excluding those requiring no immunosuppression (such as corneal transplant and hair transplant);
Subjects with active metastasis to CNS and / or carcinomatous meningitis (including leptomeningeal carcinomatosis) with clinical symptoms or requiring intervention, which is unsuitable for the subjects to enter the group as judged by the investigators;
Subjects with active autoimmune diseases in the past 1 year and consequently requiring systemic treatments (namely systemic steroids or immunosuppressive agents);
Dysphagia affects oral dosing;
Subjects with refractory third lacunar effusion, such as massive pleural effusion and ascites;
Subjects with gastrointestinal disorders that might affect drug absorption (such as Crohn's disease, ulcerative colitis, and subtotal gastrectomy);
Subjects who received any immune checkpoint blockade therapy within 4 weeks or 5 drug half-lives (the shorter duration shall prevail), or the following immune-related adverse events (irAE) have occurred during the course of previous immunotherapy:
Grade ≥3 immune-associated pneumonia; b) Grade ≥2 immune-related myocarditis;
Subjects who received major surgery within 4 weeks prior to the initial dosing or those whose wound did not completely heal yet; or subjects who received >30 Gy of chest radiotherapy within 6 months prior to the initial dosing;
Subjects with a history of myocarditis, myocardial infarction, cerebrovascular accident, or NHYA≥2 congestive cardiac failure within 6 months prior to the initial dosing; or subjects with uncontrollable angina, unstable angina, or uncontrollable arrhythmia;
Subjects who received other investigational drugs within 14 days or 5 half-lives (the longer duration shall prevail) prior to the initial dosing;
Subjects who were vaccinated with live vaccines within 30 days prior to the initial dosing, and live-virus-free influenza vaccines are allowed;
Subjects with active infections requiring systemic treatments (antibiotics); or subjects who meet any one of the following criteria:
Subjects positive for human immunodeficiency virus (HIV) or with a known history of acquired immune deficiency syndrome
Subjects with infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) (definition: HBsAg-positive and HBV DNA copy number exceeding ULN, or HCV-Ab-positive);
Subjects with active tuberculosis (with an exposure history or positive tuberculosis test, and with clinical and / or imaging manifestations).
Subjects positive for treponema pallidum antibody.
Subjects with a history of serious hypersensitivity reaction of drug;
Pregnant or breast-feeding women;
Subjects who were ineligible to participate in clinical trials as judged by the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

Guangdong Provincial People's Hospital
Guangzhou

Other trials in China

About this study

Official title: A Phase I Clinical Trial of IMMH-010 in Patients With Advanced Malignant Solid Tumors

Phase I study of IMMH-010 in patients with advanced malignant solid tumors

Read the detailed description

To evaluate the safety and tolerability of single-dose and multi-dose IMMH-010 in patients with advanced solid tumors, et al.

Conditions: Malignant Neoplasms
Being tested: IMMH-010
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMMH-010Drug
After tolerance study, 360mg and above IMMH-010 will be administered in Dose expansion study.

Study groups in NCT04343859
Study group	Role	What they receive
IMMH-010	Experimental	After Dose escalation study, Dose expansion study will be conducted : 360mg and above,IMMH-010, QD or BID,Cycle1Day1-CycleN. Receives: Drug: IMMH-010

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicity (DLT)
To identify the dose-limiting toxicity (DLT) in dose escalation study.
Measured: Part A Dose escalation study at the end of Cycle 1 (Cycle1 is 21 days)
Adverse reaction rate
Observe all the participants in any adverse events occurred during the period of clinical research, including clinical symptoms and signs of life, an abnormal in laboratory tests, record its clinical characteristics, severity, occurrence time, duration, treatment and prognosis, and determine its and the correlation between test drugs. NCI-CTCAE 5.0 standard was used to evaluate drug safety.
Measured: From date of singing informed consent until the 30 days after the last study dose or the start date of a new anti-cancer therapy, whichever came first.

Secondary outcomes (7)

Cmax
Peak plasma concentration.
Measured: Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days).
Tmax
Time to peak plasma concentration.
Measured: Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days).
AUC
Area under the plasma concentration versus time curve.
Measured: Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days).
Objective response rate (ORR)
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).
Duration of response (DOR)
DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).
Disease control rate (DCR)
DCR is defined as the percentage of participants who have BOR of CR or PR or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).
Progression-free survival (PFS)
PFS is defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 2020Dec 2024

First posted13 Apr 2020
Study start14 May 2020
Primary completionDec 2024 (estimated)
Study completionDec 2024 (estimated)

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 Malignant NeoplasmsStudies 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: Single group
Masking: None (open label)
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04343859
Sponsor's protocol ID: HR-IMMH001
Status last verified: Dec 2022
First submitted: 23 Mar 2020
Last updated: 9 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jiang J, Zou X, Liu Y, Liu X, Dong K, Yao X, Feng Z, Chen X, Sheng L, Li Y. Simultaneous Determination of a Novel PD-L1 Inhibitor, IMMH-010, and Its Active Metabolite, YPD-29B, in Rat Biological Matrices by Polarity-Switching Liquid Chromatography-Tandem Mass Spectrometry: Application to ADME Studies. Front Pharmacol. 2021 Jun 21;12:677120. doi: 10.3389/fphar.2021.677120. eCollection 2021.
PubMed 34234673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial of IMMH-010 in Patients With Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT04343859
Acronym / sponsor ID: HR-IMMH001
Conditions: Malignant Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 96 participants (estimated)
Lead sponsor: Tianjin Chasesun Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
Study start: 14 May 2020 (actual)
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 13 Apr 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.

Phase I study of IMMH-010 in patients with advanced malignant solid tumors

Detailed description

To evaluate the safety and tolerability of single-dose and multi-dose IMMH-010 in patients with advanced solid tumors, et al.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IMMH-010	Experimental	Drug: IMMH-010After Dose escalation study, Dose expansion study will be conducted : 360mg and above,IMMH-010, QD or BID,Cycle1Day1-CycleN.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Age ≥ 18 years when they sign the informed consent form;
Patients with advanced or metastatic solid tumors that are confirmed by cytological or histological examination, who did not respond to standard treatment regimens, or did not tolerate these regimens, or had no effective standard treatment regimens, or refused standard treatment regimens;
The ECOG score is 0 or 1 point (see the scoring criteria in Appendix 1);
Based on RECIST 1.1 (see the scoring criteria in Appendix 4), Subjects in Part B study must have at least one measurable lesion, and subjects in Part A study may have no measurable lesion;
In subjects who had received other treatments, the toxic and side effects should return to grade ≤ 1 or to the baseline (NCI-CTCAE 5.0, excluding alopecia);

Key exclusion criteria (26 listed)

Subjects are excluded if they meet one of the following exclusion criteria.
Subjects with a past history of pulmonary fibrosis or interstitial pneumonia, including pneumoconiosis or radiation fibrosis of lung beyond the exposure field, which is clinically significant as judged by the investigators;
Subjects who have received systemic glucocorticoid or any immunosuppressive agents for some condition within 14 days prior to the initial dosing, excluding local glucocorticoid via nose spray, aspiration, or other route, or systemic glucocorticoid at a physiological dose (namely not exceeding 10 mg/d of prednisone or an equivalent dose of other glucocorticoids); corticosteroids are allowed in subjects for pretreatment for venous contrast agent allergic reaction (scanning-relevant) in the study period, but it should be recorded.
Subjects who are expected to receive other systemic antineoplastic treatments in the study period;
Subjects with risks of intestinal obstruction or intestinal perforation, such as a history of diverticulitis, intra-abdominal abscess, active ulcer, GI tract obstruction, or abdominal cancer;

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
IMMH-010After tolerance study, 360mg and above IMMH-010 will be administered in Dose expansion study.	Drug	IMMH-010

Primary outcome

Dose-limiting toxicity (DLT)
Time frame: Part A Dose escalation study at the end of Cycle 1 (Cycle1 is 21 days)
To identify the dose-limiting toxicity (DLT) in dose escalation study.
Adverse reaction rate
Time frame: From date of singing informed consent until the 30 days after the last study dose or the start date of a new anti-cancer therapy, whichever came first.
Observe all the participants in any adverse events occurred during the period of clinical research, including clinical symptoms and signs of life, an abnormal in laboratory tests, record its clinical characteristics, severity, occurrence time, duration, treatment and prognosis, and determine its and the correlation between test drugs. NCI-CTCAE 5.0 standard was used to evaluate drug safety.

7 secondary outcomes

Cmax
Time frame: Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days).
Tmax
Time frame: Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days).
AUC
Time frame: Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days).
Objective response rate (ORR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).
Duration of response (DOR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).
Disease control rate (DCR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).
Progression-free survival (PFS)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
Derived from this study: PubMed 34234673Jiang J, Zou X, Liu Y, Liu X, Dong K, Yao X, Feng Z, Chen X, Sheng L, Li Y. Simultaneous Determination of a Novel PD-L1 Inhibitor, IMMH-010, and Its Active Metabolite, YPD-29B, in Rat Biological Matrices by Polarity-Switching Liquid Chromatography-Tandem Mass Spectrometry: Application to ADME Studies. Front Pharmacol. 2021 Jun 21;12:677120. doi: 10.3389/fphar.2021.677120. eCollection 2021.
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. This study is not recruiting at the moment.

Yilong Wu principal investigator

Guangdong Provincial People's 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 IMMH-010 in people with Malignant Neoplasms, run by Tianjin Chasesun Pharmaceutical 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 15 inclusion and 26 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 9 Nov 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?

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 toxicity (DLT) (time frame: Part A Dose escalation study at the end of Cycle 1 (Cycle1 is 21 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 NCT04343859, 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 9 Nov 2023.