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

NCT04343859 | Unknown Phase 1

• 1 other identifier: HR-IMMH001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Neoplasms

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  To identify the dose-limiting toxicity (DLT) in dose escalation study.

  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.

  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

  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

  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

  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)

  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)

  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).

Study Arms (1)

IMMH-010

EXPERIMENTAL

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

Drug: IMMH-010

Interventions

IMMH-010 DRUG

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

IMMH-010

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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;
• 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:
• a) 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;

Sponsors & Collaborators

• Tianjin Chasesun Pharmaceutical Co., LTD: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, China

Location

Related Publications (1)

• 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.

  PMID: 34234673 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Yilong Wu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 13, 2020
• Study Start: May 14, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)