Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04262466




Registration number
NCT04262466
Ethics application status
Date submitted
30/01/2020
Date registered
10/02/2020
Date last updated
2/04/2024

Titles & IDs
Public title
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Scientific title
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
Secondary ID [1] 0 0
IMC-F106C-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Select Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMC-F106C
Treatment: Drugs - IMC-F106C and pembrolizumab
Treatment: Drugs - IMC-F106C and chemotherapy
Treatment: Drugs - IMC-F106C and monoclonal antibodies and chemotherapy
Treatment: Drugs - IMC-F106C and tebentafusp
Treatment: Drugs - IMC-F106C and bevacizumab
Treatment: Drugs - IMC-F106C and kinase inhibitors

Experimental: IMC-F106C Monotherapy - Participants receive IMC-F106C.

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

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

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

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


Treatment: Drugs: IMC-F106C
IMC-F106C IV infusions

Treatment: Drugs: IMC-F106C and pembrolizumab
IMC-F106C and pembrolizumab IV infusions

Treatment: Drugs: IMC-F106C and chemotherapy
IMC-F106C and chemotherapy IV infusions

Treatment: Drugs: IMC-F106C and monoclonal antibodies and chemotherapy
IMC-F106C and a monoclonal antibody therapy and chemotherapy

Treatment: Drugs: IMC-F106C and tebentafusp
IMC-F106C and tebentafusp IV infusions

Treatment: Drugs: IMC-F106C and bevacizumab
IMC-F106C and bevacizumab IV infusions

Treatment: Drugs: IMC-F106C and kinase inhibitors
IMC-F106C and oral kinase inhibitors
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Incidence of dose-limiting toxicity (DLT)s
Timepoint [1] 0 0
Up to ~28 days after each dose
Primary outcome [2] 0 0
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)
Timepoint [2] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [3] 0 0
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations
Timepoint [3] 0 0
from first dose through last dose (anticipated for up to 12 months)
Primary outcome [4] 0 0
Phase 1: Number of participants with abnormal laboratory test results (hematology)
Timepoint [4] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [5] 0 0
Phase 1: Number of participants with abnormal laboratory test results (chemistry)
Timepoint [5] 0 0
from first dose to 30 days after the last dose
Primary outcome [6] 0 0
Phase 1: Number of participants with abnormal laboratory test results (coagulation)
Timepoint [6] 0 0
from first dose to 30 days after the last dose
Primary outcome [7] 0 0
Phase 1: Number of participants with abnormal urinalysis
Timepoint [7] 0 0
from first dose to 30 days after the last dose
Primary outcome [8] 0 0
Phase 1: Number of participants with abnormal vital signs
Timepoint [8] 0 0
from first dose to 30 days after the last dose
Primary outcome [9] 0 0
Phase 1: Mean change from baseline in QTcF interval
Timepoint [9] 0 0
Up to 30 days after the last dose of study therapy
Primary outcome [10] 0 0
Phase 2: Best overall response (BOR)
Timepoint [10] 0 0
from first dose to approximately 2 years
Secondary outcome [1] 0 0
Phase I: Best Overall Response (BOR)
Timepoint [1] 0 0
from first dose to approximately 2 years
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
from first dose to approximately 2 years
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
from first dose to approximately 2 years
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
from first dose to approximately 2 years
Secondary outcome [5] 0 0
Pharmacokinetics Area under the plasma concentration-time curve (AUC)
Timepoint [5] 0 0
approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks)
Secondary outcome [6] 0 0
Pharmacokinetics The maximum observed plasma drug concentration (Cmax)
Timepoint [6] 0 0
approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics The time to reach maximum plasma concentration (Tmax)
Timepoint [7] 0 0
approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks)
Secondary outcome [8] 0 0
Pharmacokinetics The elimination half-life (t1/2)
Timepoint [8] 0 0
approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks)
Secondary outcome [9] 0 0
Incidence of anti-IMC-F106C antibody formation
Timepoint [9] 0 0
approximately 2 years
Secondary outcome [10] 0 0
Changes in lymphocyte counts over time
Timepoint [10] 0 0
approximately 3 weeks
Secondary outcome [11] 0 0
Changes in serum cytokines over time
Timepoint [11] 0 0
approximately 3 weeks
Secondary outcome [12] 0 0
Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria
Timepoint [12] 0 0
approximately 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
727
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Melanoma Institute Australia (MIA) - The Poche Centre - Wollstonecraft
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Austria
State/province [18] 0 0
Salzburg
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussel
Country [20] 0 0
Belgium
State/province [20] 0 0
Luik
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
Brazil
State/province [25] 0 0
Porto Alegre
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
France
State/province [28] 0 0
Val De Marne
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France
State/province [29] 0 0
Villeurbanne
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France
State/province [30] 0 0
Paris
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Germany
State/province [31] 0 0
Heidelberg
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Napoli
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Netherlands
State/province [35] 0 0
CX
Country [36] 0 0
Netherlands
State/province [36] 0 0
GZ
Country [37] 0 0
Netherlands
State/province [37] 0 0
ZA
Country [38] 0 0
New Zealand
State/province [38] 0 0
Auckland
Country [39] 0 0
Poland
State/province [39] 0 0
Skórzewo
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Spain
State/province [41] 0 0
Navarra
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Switzerland
State/province [44] 0 0
Basel
Country [45] 0 0
Switzerland
State/province [45] 0 0
Zürich
Country [46] 0 0
United Kingdom
State/province [46] 0 0
City Of London
Country [47] 0 0
United Kingdom
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Oxfordshire
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United Kingdom
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Scotland
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Surrey Quays

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immunocore Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Immunocore Medical Information
Address 0 0
Country 0 0
Phone 0 0
844-466-8661
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04262466