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Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors (IMMINENT-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05840835
Recruitment Status : Recruiting
First Posted : May 3, 2023
Last Update Posted : August 8, 2023
Information provided by (Responsible Party):
Immix Biopharma, Inc.

Brief Summary:
Phase 1/2a Phase 1 is an open-label, multicenter dose escalation/dose expansion study designed to assess the safety, tolerability, pharmacokinetics (PK) and antitumor activity of IMX-110 in combination with Tislelizumab. The recommended Phase 2 dose (RP2D) will be evaluated in further dose expansion Phase 2a study submitted as an amendment to this Phase 1 protocol during the conduct of the Phase 1 study.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: IMX-110 combined with Tislelizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Open-Label, Dose-Escalation/Dose-Expansion Safety, Tolerability and Anti-tumor Activity Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Actual Study Start Date : February 3, 2023
Estimated Primary Completion Date : January 24, 2024
Estimated Study Completion Date : January 24, 2024

Arm Intervention/treatment
Experimental: IMX-110 in Combination With Tislelizumab
Patients with advanced solid tumors will be administered a combination of IMX-110 with Tislelizumab
Drug: IMX-110 combined with Tislelizumab
Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Other Name: One Arm

Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: 28 days ]
    Incidence, severity and causality of AE and serious adverse events (SAE) / Physical examination changes from baseline / Vital sign changes from baseline (heart rate, systolic/diastolic blood pressure, respiratory rate, and temperature) / Hematology and chemistry parameter changes from baseline / 12-lead ECG and 2-D Echocardiogram changes from baseline

  2. Maximum tolerated doses (MTDs) and RP2D of IMX-110 in combination with Tislelizumab [ Time Frame: 28 days ]
    MTD is defined as the highest dose at which ≤ 33% of the patients treated during the 3+3 design experience a DLT and/or at least two ≥ grade 2 non-hematologic toxicities during the first treatment cycle, and will be used to identify the RP2D to be taken forward to Phase 2a.

Secondary Outcome Measures :
  1. Plasma concentrations of IMX-110 [ Time Frame: 7 days ]
    Plasma concentration of IMX-110 will be measured when administered in treatment Cycle 1. Samples will be collected on Day 1 (pre-dose, and immediately after, 5 minutes, 1 hour, 1.5 hours, 3 hours, 5 hours post-dose), on Day 2 (pre-dose), and Day 5 (pre-dose and immediately after, 5 minutes, 1 hour, 1.5 hours, 3 hours, 5 hours post-dose), and optionally on Day 7 (pre-dose, 5 minutes, 15 minutes, 1 hour, 1.5 hours, 3 hours, 5 hours post-dose).

  2. Response Rate [ Time Frame: 8 weeks ]
    Objective Response Rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and iRECIST

  3. Progression-free survival (PFS) [ Time Frame: 5 years ]
    PFS is measured from the start of treatment to the time of progression or death, whichever occurs first while on the study.

  4. Overall Survival (OS) [ Time Frame: 5 years ]
    OS is defined as the time from Cycle 1 Day1 to death due to any cause.

  5. Duration of Response (DOR) [ Time Frame: 5 years ]
    DOR as determined by RECIST criteria version 1.1 and iRECIST

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients who are 16 years or older
  • Patients with confirmed advanced solid tumor as per histology, who have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type
  • Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (Appendix 2)
  • Patients with a life expectancy of at least 3 months
  • Patients with adequate cardiac function as measured by left ventricular ejection fraction >50%
  • Patients who have not reached a cumulative total lifetime maximum dose of 550 mg/m2 doxorubicin or per investigator discretion
  • Patients who meet the following laboratory requirements:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
  • Hemoglobin (HGB) ≥ 9.0 g/dL (patients may be transfused to achieve this HGB level)
  • Platelet count ≥ 100 x 109/L
  • Total bilirubin level ≤ 1.5 x ULN, or ≤ 3.0 x ULN for patients with Gilbert syndrome
  • AST and ALT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis present)
  • Creatinine ≤ 1.5 x ULN (Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal) (Creatinine clearance will be measured based on Cockcroft-Gault Equation).
  • Women of childbearing potential and men must agree to sexual abstinence or to use highly effective, double barrier contraception during the study and for 6 weeks following the final dose of IMX-110. Double barrier contraception is defined as a condom AND one other form of the following:
  • Birth control pills (The Pill)
  • Depot or injectable birth control
  • IUD (Intrauterine Device)
  • Birth control patch (e.g. Ortho Evra)
  • NuvaRing®
  • Documented evidence of surgical sterilization at least 6 months prior to the screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men.

Male patients must not donate sperm for at least 24 weeks post-dose of the last study treatment.

Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.

Rhythm methods during the study and for 4 months after the dose of IMX-110 + Tislelizumab will not be acceptable.

Exclusion Criteria:

  • Patients with a history of severe allergic reactions to any unknown allergens or any components of the study drug formulation.
  • Patients receiving any chemotherapy within 14 days of dosing, immunotherapy within 28 days of dosing, or biologic or hormonal therapy within 28 days of dosing for cancer treatment (exclusively). Patients with prostate cancer can continue administration of Gonadotropin-releasing hormone (GnRH) agonists.
  • Subject participating in any other drug study ≤ 4 weeks (6 weeks for immunotherapy investigational agents) or 5 half-lives of the investigational product, whichever is longer, prior to study drug administration or is scheduled to receive one during the treatment or post-treatment period.
  • Patients who are expected to need surgery or benefit from other anti-cancer therapy to be initiated during the study period.
  • Patients with a history of and/or risk factors for ischemic heart disease, congestive heart failure, symptomatic bradycardia, atrioventricular (AV) block of second degree or higher grade, prolonged QTcF interval (>450 msec in men and >470 msec in women and additional risk factors for QT prolongation (e.g. hyperthyroidism, electrolyte imbalance). (Pacemaker is not prohibited).
  • Patients who have not recovered from adverse events (AEs; ≥ CTCAE grade 2) due to prior treatment (i.e. chemotherapy, targeted therapy, radiation, or surgery) within 7 days prior to Cycle 1 Day 1, unless deemed to be irreversible, or approved by the Sponsor and Medical Monitor.
  • Females who are pregnant or lactating or intend to become pregnant before, during, or within 24 weeks after participating in this study; or intending to donate ova during such time period.
  • Patients with a known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV). Patients may be enrolled if they have HBV, HCVor HIV with viral load suppressed by anti-virals.

Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

  • Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy. Note: Patients with the following diseases are not excluded and may proceed to further screening:
  • Controlled type I diabetes (insulin dependent)
  • Hypothyroidism (provided it is managed with hormone replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
  • Any other disease that is not expected to recur in the absence of external triggering factors (requires consultation with the medical monitor prior to enrollment)
  • Indicated live vaccines should be given ≥4 weeks prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05840835

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Contact: Ilya Rachman, MD 8889581084

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Instituto do Cancer do Estado de São Paulo (ICESP) Recruiting
São Paulo, Sao Paulo, Brazil, 01246-000
Contact: Camila MV Moniz, MD    551138932645   
Principal Investigator: Camila MV Moniz, MD         
CIP Centro Integrado de Pesquisa / Hospital de Base / Fundação Faculdade de Medicina de São José do Rio Preto Recruiting
São José do Rio Preto, São Paulo, Brazil
Contact: Daniel Araujo         
Principal Investigator: Daniel Vilarim Araujo         
Sponsors and Collaborators
Immix Biopharma, Inc.
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Responsible Party: Immix Biopharma, Inc. Identifier: NCT05840835    
Other Study ID Numbers: IMX-110-002
First Posted: May 3, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents