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Trial record 1 of 1 for:    IMC-F106C-101
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Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

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ClinicalTrials.gov Identifier: NCT04262466
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Brief Summary:
IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Condition or disease Intervention/treatment Phase
Select Advanced Solid Tumors Drug: IMC-F106C Drug: IMC-F106C and pembrolizumab Drug: IMC-F106C and chemotherapy Drug: IMC-F106C and monoclonal antibodies and chemotherapy Drug: IMC-F106C and tebentafusp Drug: IMC-F106C and bevacizumab Drug: IMC-F106C and kinase inhibitors Phase 1 Phase 2

Detailed Description:

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.

  1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of IMC-F106C as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.
  2. Phase 2: To assess the efficacy of IMC-F106C in selected advanced solid tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 727 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 : June 2026
Estimated Study Completion Date : June 2026

Arm Intervention/treatment
Experimental: IMC-F106C Monotherapy
Participants receive IMC-F106C.
Drug: IMC-F106C
IMC-F106C IV infusions

Experimental: IMC-F106C and Anti-PD(L)1 Agent
Participants receive IMC-F106C and pembrolizumab.
Drug: IMC-F106C and pembrolizumab
IMC-F106C and pembrolizumab IV infusions

Experimental: IMC-F106C and Chemotherapy
Participants receive IMC-F106C and chemotherapy. Choice of chemotherapy is dependent on cohort.
Drug: IMC-F106C and chemotherapy
IMC-F106C and chemotherapy IV infusions

Experimental: IMC-F106C and Targeted Therapy
Participants receive IMC-F106C and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.
Drug: IMC-F106C and tebentafusp
IMC-F106C and tebentafusp IV infusions

Drug: IMC-F106C and bevacizumab
IMC-F106C and bevacizumab IV infusions

Drug: IMC-F106C and kinase inhibitors
IMC-F106C and oral kinase inhibitors

Experimental: IMC-F106C and Multimodal Therapy
Participants receive IMC-F106C, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.
Drug: IMC-F106C and monoclonal antibodies and chemotherapy
IMC-F106C and a monoclonal antibody therapy and chemotherapy




Primary Outcome Measures :
  1. Phase 1: Incidence of dose-limiting toxicity (DLT)s [ Time Frame: Up to ~28 days after each dose ]
  2. Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Up to 30 days after the last dose of study therapy ]
  3. Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations [ Time Frame: from first dose through last dose (anticipated for up to 12 months) ]
  4. Phase 1: Number of participants with abnormal laboratory test results (hematology) [ Time Frame: Up to 30 days after the last dose of study therapy ]
  5. Phase 1: Number of participants with abnormal laboratory test results (chemistry) [ Time Frame: from first dose to 30 days after the last dose ]
  6. Phase 1: Number of participants with abnormal laboratory test results (coagulation) [ Time Frame: from first dose to 30 days after the last dose ]
  7. Phase 1: Number of participants with abnormal urinalysis [ Time Frame: from first dose to 30 days after the last dose ]
  8. Phase 1: Number of participants with abnormal vital signs [ Time Frame: from first dose to 30 days after the last dose ]
  9. Phase 1: Mean change from baseline in QTcF interval [ Time Frame: Up to 30 days after the last dose of study therapy ]
  10. Phase 2: Best overall response (BOR) [ Time Frame: from first dose to approximately 2 years ]

Secondary Outcome Measures :
  1. Phase I: Best Overall Response (BOR) [ Time Frame: from first dose to approximately 2 years ]
  2. Progression-free survival (PFS) [ Time Frame: from first dose to approximately 2 years ]
  3. Duration of response (DOR) [ Time Frame: from first dose to approximately 2 years ]
  4. Overall survival [ Time Frame: from first dose to approximately 2 years ]
  5. Pharmacokinetics Area under the plasma concentration-time curve (AUC) [ Time Frame: approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks) ]
  6. Pharmacokinetics The maximum observed plasma drug concentration (Cmax) [ Time Frame: approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks) ]
  7. Pharmacokinetics The time to reach maximum plasma concentration (Tmax) [ Time Frame: approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks) ]
  8. Pharmacokinetics The elimination half-life (t1/2) [ Time Frame: approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks) ]
  9. Incidence of anti-IMC-F106C antibody formation [ Time Frame: approximately 2 years ]
  10. Changes in lymphocyte counts over time [ Time Frame: approximately 3 weeks ]
  11. Changes in serum cytokines over time [ Time Frame: approximately 3 weeks ]
  12. Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria [ Time Frame: approximately 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ECOG PS 0 or 1
  2. HLA-A*02:01 positive
  3. PRAME positive tumor
  4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
  5. If applicable, must agree to use highly effective contraception

Exclusion Criteria:

  1. Symptomatic or untreated central nervous system metastasis
  2. Recent bowel obstruction
  3. Ongoing ascites or effusion requiring recent drainages
  4. Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
  5. Inadequate washout from prior anticancer therapy
  6. Significant ongoing toxicity from prior anticancer treatment
  7. Out-of-range laboratory values
  8. Clinically significant lung, heart, or autoimmune disease
  9. Ongoing requirement for immunosuppressive treatment
  10. Prior solid organ or bone marrow transplant
  11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  12. Significant secondary malignancy
  13. Hypersensitivity to study drug or excipients
  14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  15. Pregnant or lactating
  16. Any other contraindication for applicable combination partner based on local prescribing information

Information from the National Library of Medicine

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


Contacts
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Contact: Immunocore Medical Information 844-466-8661 medical.information@immunocore.com
Contact: Immunocore Medical Information EU +00 800-744-51111 medinfo.eu@immunocore.com

Locations
Show Show 68 study locations
Sponsors and Collaborators
Immunocore Ltd
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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: April 2, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bevacizumab
Pembrolizumab
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action