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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.
- Phase 2: To assess the efficacy of IMC-F106C in selected advanced solid tumors.
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 |
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Experimental: IMC-F106C Monotherapy
Participants receive IMC-F106C.
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Drug: IMC-F106C
IMC-F106C IV infusions |
Experimental: IMC-F106C and Anti-PD(L)1 Agent
Participants receive IMC-F106C and pembrolizumab.
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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.
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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.
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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.
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Drug: IMC-F106C and monoclonal antibodies and chemotherapy
IMC-F106C and a monoclonal antibody therapy and chemotherapy |
- Phase 1: Incidence of dose-limiting toxicity (DLT)s [ Time Frame: Up to ~28 days after each dose ]
- 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 ]
- 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) ]
- Phase 1: Number of participants with abnormal laboratory test results (hematology) [ Time Frame: Up to 30 days after the last dose of study therapy ]
- Phase 1: Number of participants with abnormal laboratory test results (chemistry) [ Time Frame: from first dose to 30 days after the last dose ]
- Phase 1: Number of participants with abnormal laboratory test results (coagulation) [ Time Frame: from first dose to 30 days after the last dose ]
- Phase 1: Number of participants with abnormal urinalysis [ Time Frame: from first dose to 30 days after the last dose ]
- Phase 1: Number of participants with abnormal vital signs [ Time Frame: from first dose to 30 days after the last dose ]
- Phase 1: Mean change from baseline in QTcF interval [ Time Frame: Up to 30 days after the last dose of study therapy ]
- 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 ]
- Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria [ Time Frame: approximately 2 years ]
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 therapies; or, in combination with standard therapies
- If applicable, must agree to use highly effective contraception
Exclusion Criteria:
- Symptomatic or untreated central nervous system metastasis
- Recent bowel obstruction
- Ongoing ascites or effusion requiring recent drainages
- Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Out-of-range laboratory values
- Clinically significant lung, heart, or autoimmune disease
- Ongoing requirement for immunosuppressive treatment
- Prior solid organ or bone marrow transplant
- Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
- 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
- Any other contraindication for applicable combination partner based on local prescribing information
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: Immunocore Medical Information | 844-466-8661 | medical.information@immunocore.com | |
Contact: Immunocore Medical Information EU | +00 800-744-51111 | medinfo.eu@immunocore.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |