InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 28 March 2024

PRAME: This study is evaluating how safe and effective a new type of immunotherapy is in people with advanced or metastatic solid cancers that are PRAME positivePhase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Clinical summary

Summary

This study is evaluating IMC-F106C, an immune-mobilising monoclonal T cell receptor against cancer that is designed for the treatment of cancers positive for the tumour-associated antigen PRAME. The study will be conducted in two phases:

Phase 1: Aims 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 a checkpoint inhibitor, chemotherapy, or another ImmTAC molecule.

Phase 2: Aims to assess the efficacy of IMC-F106C as a single agent in selected advanced solid cancers.

 

Conditions

This trial is treating patients with advanced solid cancers that are HLA-A*02:01 and PRAME positive

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

PRAME

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Immunocore Ltd

Scientific Title

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Eligibility

Inclusion

  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 therapy
  5. If applicable, must agree to use highly effective contraception
  6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol

Exclusion

  1. Symptomatic or untreated central nervous system metastasis
  2. Recent bowel obstruction
  3. Ascites requiring recurrent paracentesis
  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) or hepatitis C virus (HCV) infection
  12. Known history of human immunodeficiency virus (HIV)
  13. Significant secondary malignancy
  14. Hypersensitivity to study drug or excipients
  15. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  16. Pregnant or lactating
  17. Any other contraindication for applicable combination partner based on local prescribing information

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.