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.|
|ClinicalTrials.gov Identifier: NCT05840835|
Recruitment Status : Recruiting
First Posted : May 3, 2023
Last Update Posted : August 8, 2023
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: IMX-110 combined with Tislelizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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).
- 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
- 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.
- Overall Survival (OS) [ Time Frame: 5 years ]OS is defined as the time from Cycle 1 Day1 to death due to any cause.
- Duration of Response (DOR) [ Time Frame: 5 years ]DOR as determined by RECIST criteria version 1.1 and iRECIST
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 ClinicalTrials.gov identifier (NCT number): NCT05840835
|Contact: Ilya Rachman, MDemail@example.com|
|Instituto do Cancer do Estado de São Paulo (ICESP)||Recruiting|
|São Paulo, Sao Paulo, Brazil, 01246-000|
|Contact: Camila MV Moniz, MD 551138932645 firstname.lastname@example.org|
|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|