IV ICT01 for Blood Cancers

Gustave Roussy, Paris, France
Blood Cancers+1 More ConditionsIV ICT01 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test a new antibody drug, ICT01, either alone or in combination with another drug, pembrolizumab, in patients with advanced solid or blood cancers.

Eligible Conditions
  • Solid Tumors, Adult
  • Blood Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

4 Primary · 8 Secondary · Reporting Duration: 12 months

1 day
Cmax following the first dose of ICT01
12 months
Adverse Events (Parts 1 & 2)
Disease Control Rate using RECIL for lymphoma patients (Part 2)
Disease Control Rate using RECIST for solid tumor patients (Part 2)
Objective Response Rate using RECIST for solid tumor patients (Part 2)
21 days
AUC following the first dose of ICT01
28 days
Change from Baseline in the Activation State of Circulating Gamma Delta T Cells
Change from Baseline in the Number of Circulating Gamma Delta T Cells
6 months
Clearance at steady-state of ICT01
Half-life of ICT01
Objective Response Rate using RECIL for lymphoma patients (Part 2)
Objective Response Rate using iRECIST for solid tumor patients (Part 2)

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

IV ICT01 Monotherapy
1 of 2
IV ICT01 + IV Pembrolizumab
1 of 2

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: IV ICT01 · No Placebo Group · Phase 1 & 2

IV ICT01 Monotherapy
Biological
Experimental Group · 1 Intervention: IV ICT01 · Intervention Types: Biological
IV ICT01 + IV Pembrolizumab
Biological
Experimental Group · 1 Intervention: IV ICT01 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

ImCheck TherapeuticsLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Paul Frohna, MD, PhDStudy DirectorImCheck Therapeutics
2 Previous Clinical Trials
126 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with advanced or recurrent cancer that falls under certain categories, including bladder, breast, colon, gastric, melanoma, ovarian, prostate, and pancreatic cancer, or certain types of leukemia and lymphoma. You must also meet certain health criteria, such as having a certain level of T cells and a life expectancy of at least three months, and have at least one measurable lesion according to specific evaluation criteria.

Frequently Asked Questions

What is the target outcome of this experimental endeavor?

"This 12-month clinical trial will measure its primary outcome, Disease Control Rate using RECIST for solid tumor patients (Part 2), and several secondary outcomes such as Change from Baseline in the Number of Circulating Gamma Delta T Cells, Half-life of ICT01, and Objective Response Rate using RECIST for solid tumor patients (Part 2)." - Anonymous Online Contributor

Unverified Answer

What is the total participant capacity of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting volunteers with the initial posting on February 10th 2020 and most recent update on October 5th 2022. 150 participants are needed from a single location to complete the trial." - Anonymous Online Contributor

Unverified Answer

Is enrollment currently open for this experiment?

"Based on what is available through clinicaltrials.gov, this study is still enrolling participants. It was initially posted back in February 10th 2020 and has since been modified as recently as October 5th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.