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RecruitingLast updated: 20 April 2026

EMITT-1(GREYWOLF): This study is seeking to determine how safe and tolerable a new cancer drug (called GRWD5769) is in people with advanced solid cancersA modular, multi-part, multi-arm, open-label, Phase I/II Study to evaluate the safety and tolerability of GRWD5769 in patients with solid malignancies - Module 1.

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

EMITT-1(GREYWOLF)

Clinical summary

Summary

This study aims to assess a new cancer drug, GRWD5769, in people with advanced cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older, have a locally advanced or metastatic solid cancer that is not suitable for further treatment, and your cancer has progressed after prior treatments.

Study details
All participants will receive treatment with GRWD5769. After an initial single dose, GRWD5769 will be given as an oral capsule throughout the study twice a day. Treatment will continue until participants withdraw from the study or their disease progresses.

During the treatment period, participants will visit the study site for screening and an initial confinement period beginning up to 2 days prior to the first dose until Day 2 of Cycle 1 (a minimum of 2 nights). Further confinement periods are required for assessments on Day 14 and Day 15 of Cycle 1. Participants will also have scans every 56 days throughout the study to assess for their response to treatment.

It is hoped that this study will show that GRWD5769 is safe, tolerable, and effective for the treatment of advanced solid cancers. This study will also help to define the dose of GRWD5769 that may be used for treatment of similar individuals in future.

 

Conditions

This trial is treating people with locally advanced or metastatic solid cancers that have progressed on prior treatment, and for whom no further treatment options are available

Eligibility

Inclusion

Module 1A, 1B & 1C
1. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy for which no further standard of care (SoC) therapy is available (or no SoC therapy exists), or who have been offered and declined SoC therapy, or are intolerant of SoC therapy.
2. Participant has measurable disease per RECIST 1.1/iRECIST.

Module 1B specific
3. Participant has at least one tumour lesion amenable to serial biopsies and is willing to
provide consent for biopsies and has measurable disease per RECIST 1.1/iRECIST,
excluding the lesion(s) identified for biopsy.

Module 1D specific
Additional selection criteria for Module 1 Part D will be described in a
future protocol amendment.

Exclusion

 

All study Modules 1:
1. Prior therapy with an ERAP1 inhibitor, within any timeframe prior to the first dose of study drug.
2. Any other malignancy not meeting inclusion criterion 1 (Module 1 Parts A, B, and C), which has been active or treated within the past 3 years, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer.
3. Any unresolved toxicity (except alopecia) from prior therapy of greater than or equal to CTCAE Grade 1 prior to the day of the first dose of IMP. Participants with Grade 2 toxicity that is not clinically significant (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
4. Active or documented history of autoimmune disease (within 2 years) requiring systemic immunosuppressive therapy, or participant is immunocompromised for any other reason (as determined by the Investigator).

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

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, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Grey Wolf Therapeutics Pty Ltd

Scientific Title

A modular, multi-part, multi-arm, open-label, Phase I/II Study to evaluate the safety and tolerability of GRWD5769 in patients with solid malignancies - Module 1.

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