Trial · NCT06699836
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with relapsed, refractory, MSS, mCRC. | From enrolment through end of treatment at 12 months | Efficacy will be measured as the effect on objective response rate (ORR) of leronlimab when used in combination with trifluridine and tipiracil + bevacizumab in patients with relapsed, refractory, MSS, mCRC. ORR is defined as the proportion of subjects with the best overall response (BOR) or confirmed CR or confirmed PR according to RECIST v1.1. |
| Secondary | The efficacy of leronlimab in combination with pembrolizumab in participants with MSS, mCRC who have documented progressive disease (PD) during the initial treatment period of the study. | From initiation of treatment in the leronlimab plus pembrolizumab cohort through end of treatment, up to 48 weeks. | Efficacy will be measured as the effect on objective response rate (ORR) of leronlimab when used in combination with pembrolizumab in participants with MSS, mCRC who entered the leronlimab plus pembrolizumab cohort. ORR is defined as the proportion of subjects with the best overall response (BOR) or confirmed CR or confirmed PR according to RECIST v1.1. |
| Secondary | Assessment of safety and tolerability of leronlimab when used in combination with trifluridine and tipiracil + bevacizumab or in combination with pembrolizumab in patients with relapsed, refractory, MSS, mCRC. | From enrollment through end of treatment, up to approximately 24 months. | Treatment Emergent AE's (TEAE) are defined as events with an onset on or after the first treatment. TEAEs will be summarized by treatment group, System Organ Class, and preferred term. The following TEAE summaries will be provided: * All TEAEs * TEAEs related to study drug. * All TEAEs by severity * Serious TEAEs * Serious TEAEs related to study drug. * TEAE reported in 5% or more participants in any treatment group. * TEAEs leading to discontinuation of study treatment. * TEAEs leading to interruption of study treatment. * TEAEs leading to death. |
| Secondary | Assessment of the duration of response (DOR) of leronlimab in combination with trifluridine and tipiracil + bevacizumab and leronlimab in combination with pembrolizumab in participants with relapsed, refractory, MSS, mCRC. | From enrolment through end of treatment, up to 48 weeks. | The time from the first documentation of response, either partial or complete, to the documentation of the objective tumor progression or until death due to any cause. |
| Secondary | Assessment of PK parameters of leronlimab during the 12-month treatment period. | From enrolment through end of treatment at 12 months. | PK parameters will be calculated following multiple dosing during the Treatment Period (12 months) and will include the following: * Cmax, Tmax, AUC0-168, AUC0-last, and AUC0-τ, trough concentrations * AUC0-inf, t1/2, CL/F, and Vz/F. |
| Secondary | Evaluation of immunogenicity of leronlimab during treatment period and follow-up. | From enrolment through 12 months and approximately 30 days post treatment follow-up. | Incidence of Anti-Drug-Antibodies from pre-dose baseline through 52 weeks of treatment and approximately 30 days post treatment during follow-up. Incidence of Neutralizing Antibodies from pre-dose baseline through 52 weeks of treatment and approximately 30 days post treatment during follow-up. |
| Secondary | Assessment of the DCR (disease control rate) per RECIST criteria (v1.1) for leronlimab in combination with trifluridine and tipiracil + bevacizumab and with pembrolizumab of patients with relapsed, refractory, mCRC. | From enrolment through end of treatment at 24 months. | The proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) lasting at least 6 weeks as their best overall response during treatment, as determined according to RECIST v1.1. |
| Secondary | Assessment of individual progression free survival (PFS). | From first treatment through end of study (up to 160 weeks) | Time from the date of first treatment to the first documented objective radiographic tumor progression per RECIST v1.1 or death from any cause, whichever occurs first. |
| Secondary | Assessment of individual overall survival (OS). | From first treatment through end of study (up to 160 weeks). | Time from date of first treatment until death from any cause. |
| Other | Exploratory biomarkers correlating with clinical response. | From baseline through week 52 and approximately 30 days post-treatment follow-up. | Measurement of serum CCL2, CCL3, CCL4, and CCL5 levels and evaluation of change from baseline, and assessment of their association with clinical response to study treatment. |
| Other | Change in Circulating Tumor Cells (CTCs) From Baseline (Exploratory) | From baseline through week 52 and approximately 30 days post-treatment follow-up. | Evaluation of the change in circulating tumor cells (CTCs; CTCs/mL) in peripheral blood from baseline to response assessment during study treatment. |
| Other | Exploratory analysis of CCR5 expression at baseline. | From screening through pre-dose on Cycle 1 Day 1 (baseline). | Assessment of CCR5 expression in CRC tissue (primary or metastatic) at baseline to characterize biomarker status prior to first dose of leronlimab. |
| Other | Exploratory Analysis of CCR5 Haplotypes and Clinical Response | From screening through pre-dose on Cycle 1 Day 1 (baseline). | Determination of CCR5 genotype and haplotypes in participants at baseline using blood samples collected prior to initiation of study treatment. |
| Other | Exploratory Analysis of PD-L1 Expression on CTCs and/or CAMLs from baseline | From baseline through week 52 and approximately 30 days post-treatment follow-up. | Evaluation of the change in PD-L1 expression on circulating tumor cells (CTCs) and/or cancer-associated macrophage-like cells (CAMLs) from baseline through study follow-up assessments. |
| Other | Exploratory Analysis of circulating tumor DNA (ctDNA) from baseline | From baseline through the Extension Treatment Period, up to 104 weeks. | Evaluation of the change in ctDNA from baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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