Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
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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: NCT04262466 |
Recruitment Status :
Recruiting
First Posted : February 10, 2020
Last Update Posted : March 14, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Select Advanced Solid Tumors | Drug: IMC-F106C Drug: anti-PD(L)1 | Phase 1 Phase 2 |
The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases.
- Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of IMC-F106C as a single agent (Arm A) and administered in combination with Checkpoint Inhibitors (Arm B).
- Phase 2: To assess the preliminary anti-tumor activity of IMC-F106C as a single agent administration.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 170 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers |
Actual Study Start Date : | February 25, 2020 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | February 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: IMC-F106C - Arm A - Phase 1
Dose Escalation
|
Drug: IMC-F106C
Weekly IV Infusions |
Experimental: IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1
Dose Escalation
|
Drug: IMC-F106C
Weekly IV Infusions Drug: anti-PD(L)1 Every 3 weeks |
Experimental: IMC-F106C - Phase 2
Monotherapy dose expansion
|
Drug: IMC-F106C
Weekly IV Infusions |
- Phase 1: Incidence of Dose-limiting toxicity (DLT)s [ Time Frame: From first dose to DLT period (28 days) ]
- Phase 1: incidence and severity of adverse events (AE) and serious adverse events (SAE) [ Time Frame: from first dose to 30 days after the last dose ]
- Phase 1: changes in laboratory parameters [ Time Frame: from first dose to 30 days after the last dose ]Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) laboratory abnormalities
- Phase 1: changes in vital signs [ Time Frame: from first dose to 30 days after the last dose ]Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) vital sign abnormalities
- Phase 1: changes in electrocardiogram parameters [ Time Frame: from first dose to 30 days after the last dose ]QTcF interval absolute values and changes from baseline will be summarized
- Phase 1: dose interruptions, reductions, and discontinuations [ Time Frame: from first dose through last dose (anticipated for up to 12 months) ]Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment due to adverse event Number of participants with, and rate of, dose interruption, dose reduction, permanent discontinuation of study treatment due to treatment-related adverse event
- Phase 2: Best overall response (BOR) [ Time Frame: from first dose to approximately 2 years ]
- Phase I: Best Overall Response (BOR) [ Time Frame: from first dose to approximately 2 years ]
- Progression-free survival (PFS) [ Time Frame: from first dose to approximately 2 years ]
- Duration of response (DOR) [ Time Frame: from first dose to approximately 2 years ]
- Overall survival [ Time Frame: from first dose to approximately 2 years ]
- Pharmacokinetics Area under the plasma concentration-time curve (AUC) [ Time Frame: approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks) ]
- Pharmacokinetics The maximum observed plasma drug concentration (Cmax) [ Time Frame: approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks) ]
- Pharmacokinetics The time to reach maximum plasma concentration (Tmax) [ Time Frame: approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks) ]
- Pharmacokinetics The elimination half-life (t1/2) [ Time Frame: approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks) ]
- Incidence of anti-IMC-F106C antibody formation [ Time Frame: approximately 2 years ]
- Changes in lymphocyte counts over time [ Time Frame: approximately 3 weeks ]
- Changes in serum cytokines over time [ Time Frame: approximately 3 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ECOG PS 0 or 1
- HLA-A*02:01 positive
- PRAME positive tumor
- Relapsed from, refractory to, or intolerant of standard therapy
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
Exclusion Criteria:
- Symptomatic or untreated central nervous system metastasis
- Recent bowel obstruction
- Ascites requiring recurrent paracentesis
- Significant immune-mediated adverse event with prior immunotherapy (patients in combination treatment)
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Out-of-range laboratory values
- Clinically significant medical condition
- Ongoing requirement for immunosuppressive treatment
- Prior solid organ or bone marrow transplant
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Known history of human immunodeficiency virus (HIV)
- Significant secondary malignancy
- Hypersensitivity to study drug or excipients
- Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
- Pregnant or lactating

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): NCT04262466
Contact: Shaad E Abdullah, MD, FACP | 484-534-5261 | clinicaltrials@immunocore.com | |
Contact: Mohammed Dar | 1-844-466-8661 | clinicaltrials@immunocore.com |
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Contact: Jeane Painter | |
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Sarah Cannon Research Institute UK | Recruiting |
London, City Of London, United Kingdom, W1G6AD | |
Contact: Maria Victoria Borja Beral | |
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The Christie NHS Foundation Trust | Recruiting |
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Contact: Jessica Ritchie | |
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Royal Marsden Hospital | Recruiting |
Surrey Quays, United Kingdom, SM25PT | |
Contact: Dan Bar | |
Contact: Mahesha Ganegoda | |
Principal Investigator: Juanita Lopez, MD |
Study Director: | Shaad Abdullah, MD, FACP | Immunocore Ltd |
Responsible Party: | Immunocore Ltd |
ClinicalTrials.gov Identifier: | NCT04262466 |
Other Study ID Numbers: |
IMC-F106C-101 |
First Posted: | February 10, 2020 Key Record Dates |
Last Update Posted: | March 14, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ImmTAC Immunotherapy Bispecific T cell receptor fusion protein Immune mobilizing monoclonal T cell receptor against cancer |
Checkpoint inhibitor PD1 / PD-1 PD-L1 / PDL1 |