A clinical trial to determine the safety and tolerability of GRWD5769 in patients with solid malignancies.

Phase 1

Recruiting

• Conditions: Advanced solid malignancies; Cancer - Any cancer

• Registration Number: ACTRN12623000108617
• Lead Sponsor: Grey Wolf Therapeutics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-31
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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 Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified