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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06840119




Registration number
NCT06840119
Ethics application status
Date submitted
5/02/2025
Date registered
25/03/2025
Date last updated
25/03/2025

Titles & IDs
Public title
Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
Scientific title
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers
Secondary ID [1] 0 0
2023-508090-87-00
Secondary ID [2] 0 0
IMC-R117C-1004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
HLA-A*02:01-positive 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMC-R117C
Treatment: Drugs - Chemotherapy drug
Treatment: Drugs - Chemotherapy drug
Treatment: Drugs - Kinase inhibitor
Treatment: Drugs - Antiangiogenic Agent
Treatment: Drugs - Monoclonal antibody

Experimental: Arm A: IMC-R117C Monotherapy Dose-Escalation - Participants receive IMC-R117C intravenous (IV) infusion.

Experimental: Arm B: IMC-R117C Combination Dose-Escalation - Participants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent

Experimental: Arm C: IMC-R117C Combination Dose-Escalation - Participants receive IMC-R117C IV infusion with targeted therapies

Active comparator: Arm D: Control Arm - Participants receive standard of care chemotherapy and antiangiogenic agent


Treatment: Drugs: IMC-R117C
IV infusion

Treatment: Drugs: Chemotherapy drug
IV infusion

Treatment: Drugs: Chemotherapy drug
oral

Treatment: Drugs: Kinase inhibitor
oral

Treatment: Drugs: Antiangiogenic Agent
IV infusion

Treatment: Drugs: Monoclonal antibody
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Percentage of participants with =1 dose-limiting toxicity (DLT)
Timepoint [1] 0 0
Up to ~24 months
Primary outcome [2] 0 0
Dose Escalation: Percentage of participants with =1 adverse event (AE)
Timepoint [2] 0 0
Up to ~24 months
Primary outcome [3] 0 0
Dose Escalation: Percentage of participants with =1 serious adverse event (SAE)
Timepoint [3] 0 0
Up to ~24 months
Primary outcome [4] 0 0
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Timepoint [4] 0 0
Up to ~24 months
Primary outcome [5] 0 0
Dose Escalation: Percentage of participants with significant changes in vital signs
Timepoint [5] 0 0
Up to ~24 months
Primary outcome [6] 0 0
Dose Escalation: Percentage of participants with significant changes in laboratory results
Timepoint [6] 0 0
Up to ~24 months
Primary outcome [7] 0 0
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation
Timepoint [7] 0 0
Up to ~24 months
Primary outcome [8] 0 0
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1
Timepoint [8] 0 0
Up to ~24 months
Secondary outcome [1] 0 0
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination
Timepoint [1] 0 0
Up to ~36 months
Secondary outcome [2] 0 0
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination
Timepoint [2] 0 0
Up to ~36 months
Secondary outcome [3] 0 0
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination
Timepoint [3] 0 0
Up to ~36 months
Secondary outcome [4] 0 0
Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination
Timepoint [4] 0 0
Up to ~36 months
Secondary outcome [5] 0 0
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy
Timepoint [5] 0 0
Up to ~36 months
Secondary outcome [6] 0 0
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy
Timepoint [6] 0 0
Up to ~36 months
Secondary outcome [7] 0 0
Expansion: Overall Survival (OS) with IMC-R117C Monotherapy
Timepoint [7] 0 0
Up to ~36 months
Secondary outcome [8] 0 0
Expansion: Percentage of participants with =1 Adverse Events (AE)
Timepoint [8] 0 0
Up to ~24 months
Secondary outcome [9] 0 0
Expansion: Percentage of participants with =1 Serious Adverse Events (SAE)
Timepoint [9] 0 0
Up to ~24 months
Secondary outcome [10] 0 0
Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Timepoint [10] 0 0
Up to ~24 months
Secondary outcome [11] 0 0
Expansion: Percentage of participants with significant changes in vital signs
Timepoint [11] 0 0
Up to ~24 months
Secondary outcome [12] 0 0
Expansion: Percentage of participants with significant changes in laboratory findings
Timepoint [12] 0 0
Up to ~24 months
Secondary outcome [13] 0 0
Expansion: Percentage of participants with dose interruptions, reductions, or discontinuation
Timepoint [13] 0 0
Up to ~24 months
Secondary outcome [14] 0 0
All Study: Plasma Concentration of IMC-R117C
Timepoint [14] 0 0
Up to ~36 months
Secondary outcome [15] 0 0
All Study: Incidence of anti-IMC-R117C Antibody Formation
Timepoint [15] 0 0
Up to ~36 months
Secondary outcome [16] 0 0
All Study: Incidence of tumor expression and localization of PIWIL1
Timepoint [16] 0 0
Up to ~36 months

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* HLA-A*02:01-positive
* Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma
* Archived or fresh tumor tissue sample that must be confirmed as adequate
* Evaluable/Measurable disease per RECIST 1.1
* Previously received applicable standard treatments
* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Symptomatic or untreated central nervous system metastasis
* Recent bowel obstruction
* Ongoing ascites or effusion requiring recent drainages
* Significant ongoing toxicity from prior anticancer treatment
* Out-of-range laboratory values
* Clinically significant lung, heart, or autoimmune disease
* Ongoing requirement for immunosuppressive treatment
* Significant secondary malignancy
* Hypersensitivity to study drug or excipients
* Pregnant or lactating

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
10/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Anderlecht
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Netherlands
State/province [4] 0 0
Amsterdam
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Spain
State/province [6] 0 0
Madrid

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/NCT06840119