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IMC-F106C for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado, Aurora, COSolid TumorsIMC-F106C - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is designed to see if a new T cell receptor, IMC-F106C, is safe and effective in treating patients with cancer that is positive for the tumor-associated antigen PRAME.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

7 Primary · 11 Secondary · Reporting Duration: approximately 2 years

Day 28
Phase 1: Incidence of Dose-limiting toxicity (DLT)s
approximately 2 years
Incidence of anti-IMC-F106C antibody formation
approximately 3 weeks
Changes in lymphocyte counts over time
Changes in serum cytokines over time
Week 3
Pharmacokinetics Area under the plasma concentration-time curve (AUC)
Week 3
Pharmacokinetics The maximum observed plasma drug concentration (Cmax)
Week 3
Pharmacokinetics The time to reach maximum plasma concentration (Tmax)
Week 3
Pharmacokinetics The elimination half-life (t1/2)
Month 12
Phase 1: dose interruptions, reductions, and discontinuations
Day 30
Phase 1: changes in electrocardiogram parameters
Phase 1: changes in laboratory parameters
Phase 1: changes in vital signs
Phase 1: incidence and severity of adverse events (AE) and serious adverse events (SAE)
Year 2
Duration of response (DOR)
Overall survival
Phase 2: Best overall response (BOR)
Phase I: Best Overall Response (BOR)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

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1
KAZ954
1
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1
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Trial Design

6 Treatment Groups

IMC-F106C - Arm A - Phase 1 and Phase 2
1 of 6
IMC-F106C and chemotherapy - Arm C - Phase 1
1 of 6
IMC-F106C and another ImmTAC - Arm D - Phase 1
1 of 6
IMC-F106C - Arm A - Phase 1
1 of 6
IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1
1 of 6
IMC-F106C - Phase 2
1 of 6

Experimental Treatment

170 Total Participants · 6 Treatment Groups

Primary Treatment: IMC-F106C · No Placebo Group · Phase 1 & 2

IMC-F106C - Arm A - Phase 1 and Phase 2
Drug
Experimental Group · 1 Intervention: IMC-F106C · Intervention Types: Drug
IMC-F106C and chemotherapy - Arm C - Phase 1
Drug
Experimental Group · 1 Intervention: IMC-F106C and chemotherapy · Intervention Types: Drug
IMC-F106C and another ImmTAC - Arm D - Phase 1
Drug
Experimental Group · 1 Intervention: IMC-F106C and tebentafusp · Intervention Types: Drug
IMC-F106C - Arm A - Phase 1
Drug
Experimental Group · 1 Intervention: IMC-F106C · Intervention Types: Drug
IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1Experimental Group · 3 Interventions: IMC-F106C, IMC-F106C and atezolizumab and pembrolizumab, anti-PD(L)1 · Intervention Types: Drug, Drug, Drug
IMC-F106C - Phase 2
Drug
Experimental Group · 1 Intervention: IMC-F106C · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years

Who is running the clinical trial?

Immunocore LtdLead Sponsor
10 Previous Clinical Trials
2,406 Total Patients Enrolled
Shaad Abdullah, MDStudy DirectorImmunocore Ltd
1 Previous Clinical Trials
29 Total Patients Enrolled
Shaad Abdullah, MD, FACPStudy DirectorImmunocore Ltd

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have already tried standard treatment, but it did not work or you could not tolerate it.
If you can become pregnant, you must agree to use a very effective form of birth control during the study.
References

Frequently Asked Questions

What is the cap on participant enrollment in this research endeavor?

"Immunocore Ltd is the sponsor of this trial, which requires 170 qualified participants. Memorial Sloan Kettering in New York and Thomas Jefferson University Hospital in Philadelphia are two locations where patients can be treated." - Anonymous Online Contributor

Unverified Answer

How many medical facilities are conducting this investigation concurrently?

"Nine clinical trial sites are currently recruiting patients for this medical research, located in New York City, Philadelphia and Houston amongst other cities. It is suggested that participants select the nearest location to reduce their commute when possible." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this experiment still open?

"Per the documentation on clinicaltrials.gov, this research study is currently seeking participants. It was initially listed on February 25th 2020 and has been revised as recently as March 10th 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.

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