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

Phase 1

• Conditions: Advanced solid malignancies; Cancer - Any cancer

• Registration Number: ACTRN12623001077651
• Lead Sponsor: Grey Wolf Therapeutics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-10
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Module 2A specific
1. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy and has received at least one line of prior therapy or has no further (or has refused) standard of care options.
2. Participant has measurable disease per RECIST 1.1/iRECIST.
Module 2B specific
1. Participant has cytologically or histologically confirmed locally advanced or metastatic
solid malignancy.
2. Participant has confirmed progressive disease after treatment with an anti-PD-1 or anti-
PD-L1 mAb, following a minimum treatment duration of 12 weeks (or at least 2 response
evaluations).
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 2C specific
Additional selection criteria for Module 2 Part C will be described in a
future protocol amendment.

Exclusion Criteria

All Module 2
1. Prior therapy with an ERAP1 inhibitor, within any timeframe prior to the first dose of
study drug at Cycle 0, Day 1.
2. Any other malignancy not meeting inclusion criterion 1 which has been active or treated
within the past 3 years, with the exception of cervical intraepithelial neoplasia and nonmelanoma skin cancer.
3. Any unresolved toxicity (except alopecia) from prior therapy of greater than or equal to CTCAE Grade 3, prior to the first dose of IMP at Cycle 0, Day 1.
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).
5. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not
requiring steroids for at least 4 weeks before the first dose of IMP (if stable and requiring
no intervention, the participant can be enrolled in the study).
6. Uncontrolled seizures
7. Active infection requiring intravenous antibiotic, antifungal, or antiviral medication or hospital admission within 14 days prior to first dose of study drug
8. Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary
disease, severe Parkinson’s disease, active inflammatory bowel disease) or psychiatric
condition
9. Active bleeding diatheses
10. Participant has received an organ transplant
11. Known hepatitis B, hepatitis C, Epstein-Barr virus (EBV) or human immunodeficiency
virus infection (HIV).
12. Participant is breastfeeding or pregnant
13. Receipt of licensed or unlicensed cytotoxic, non-cytotoxic or small molecule therapy for the malignancy within 28 days or 5 half-lives,
whichever is shorter, prior to the first dose of IMP at Cycle 0, Day 1
14. Receipt of oral corticosteroids (at a dose greater than 10 mg prednisone/day or equivalent) within 14 days prior to the first dose of IMP (except for subjects receiving corticosteroids for adrenal insufficiency) at Cycle 0, Day 1
15. Receipt of St John’s Wort within 21 days prior to the first dose of IMP or of another
concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer
of CYP3A4 enzymes within 14 days prior to the first dose of IMP at Cycle
0, Day 1
16. Receipt of a blood transfusion (blood or blood products) within 14 days prior to the first
dose of IMP at Cycle 0, Day 1
17. Impaired hepatic or renal function as demonstrated by any of the following laboratory
values:
a. Albumin less than 30 g/L.
b. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5 times the
upper limit of normal (ULN) (greater than 5.0 times ULN for participants with liver metastases).
c. Total bilirubin greater than 1.5 times ULN (for participants with gilbert's syndrome, ULN is considered to be 2.9 mg per ml)
d. Serum creatinine greater than 1.5 times ULN.
18. Liver function deteriorating in a manner that would likely make the participant meet the
AST, ALT, or bilirubin levels specified above prior to the first dose of IMP at Cycle 0,
Day 1.
19. Other evidence of impaired hepatic synthesis function.
20. Inadequate bone marrow reserve or organ function as demonstrated by any of the
following laboratory values:
a. Absolute neutrophil count (ANC) less than 1.5 times 109/L.
b. Platelet count less than 100 times 109/L.
c. Haemoglobin less than 90 g/L.
21. Any prior history of persistent (greater than 4 weeks) severe pancytopeni

Study & Design

• Study Type: Interventional
• Study Design: Not specified