AzTrials
AzTrials

Advanced Solid TumorPhase 1/2IMMINENT-01NCT05840835

Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors

A Phase 1/2 study testing IMX-110 combined with Tislelizumab in people with Advanced Solid Tumor, run by Immix Biopharma, Inc. at 2 sites in Brazil.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
IMX-110 combined with Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesBrazil
Study dates
3 Feb 2023to 24 Jan 2024
Phase
Phase 1/2
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Ilya Rachman, MD contact

8889581084

info@immixbio.com

Brazil2 sites, 2 recruiting

  • CIP Centro Integrado de Pesquisa / Hospital de Base / Fundação Faculdade de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo

    Daniel Araujo

    Daniel Vilarim Araujo

    Recruiting

  • Instituto do Cancer do Estado de São Paulo (ICESP)

    São Paulo, São Paulo, 01246-000

    Camila MV Moniz, MD, 551138932645, camila.venchiarutti@hc.fm.usp.br

    Camila MV Moniz, MD

    Recruiting

Other trials in Brazil

About this study

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

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.

Being tested
IMX-110 combined with Tislelizumab

What participants receive

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

  • IMX-110 combined with TislelizumabDrug

    Also called One Arm

    Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors

Study groups in NCT05840835
Study groupRoleWhat they receive
IMX-110 in Combination With TislelizumabExperimentalPatients with advanced solid tumors will be administered a combination of IMX-110 with Tislelizumab
Receives: Drug: IMX-110 combined with Tislelizumab

What is being measured

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

  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    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

    Measured: 28 days

  2. Maximum tolerated doses (MTDs) and RP2D of IMX-110 in combination with Tislelizumab

    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.

    Measured: 28 days

Secondary outcomes (5)

  1. Plasma concentrations of IMX-110

    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).

    Measured: 7 days

  2. Response Rate

    Objective Response Rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and iRECIST

    Measured: 8 weeks

  3. Progression-free survival (PFS)

    PFS is measured from the start of treatment to the time of progression or death, whichever occurs first while on the study.

    Measured: 5 years

  4. Overall Survival (OS)

    OS is defined as the time from Cycle 1 Day1 to death due to any cause.

    Measured: 5 years

  5. Duration of Response (DOR)

    DOR as determined by RECIST criteria version 1.1 and iRECIST

    Measured: 5 years

Timeline

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

  1. First posted3 May 2023
  2. Study start3 Feb 2023
  3. Primary completion24 Jan 2024 (estimated)
  4. Study completion24 Jan 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840835
Sponsor's protocol ID
IMX-110-002
Acronym
IMMINENT-01
Status last verified
Aug 2023
First submitted
4 Jan 2023
Last updated
8 Aug 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMX-110 combined with Tislelizumab in people with Advanced Solid Tumor, run by Immix Biopharma, Inc. at 2 sites in Brazil.

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 23 inclusion and 16 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ilya Rachman, MD (8889581084, info@immixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: 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?

On the ClinicalTrials.gov record for NCT05840835.

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 8 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in