A modular, multi-arm, multi-part, first time in patient study to evaluate the safety and tolerability of OMO-1, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies

Completed

• Conditions: Cancer; Malignancy; 10027655

• Registration Number: NL-OMON48960
• Lead Sponsor: OCTIMET Oncology NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Core:
* Aged at least 18 years.
* Provision of signed and dated, written informed consent.
* Histological or cytological confirmation of locally advanced,
unresectable or metastatic solid malignancy
* Performance status: Eastern Co-operative Oncology Group (ECOG) *1
and life expectancy *3 months.
* Patients must have recovered from toxicities of prior therapies (i.e.
CTCAE Grade *1).
* Ability to swallow and retain oral medication.
* Adequate organ functions.
* Not receiving other cancer therapy, or other investigational product,
apart from the combination agent(s) described in the relevant
combination module(s).
* No radiotherapy for the primary tumour within 1 week from
screening visit.
* Not receiving medications predominantly metabolized by CYP2B6.
Washout period for medications predominantly metabolized by CYP2B6,
apart for tamoxifen, is 7 days prior to the first dose of study treatment.
Washout period for tamoxifen is 2 months prior to the first dose of study
treatment
* Not receiving cannabinoid substances and St. John's Wort.
Washout period for cannabinoid substances and St. John's Wort is 5 and
7 days respectively prior to the first dose of study treatment.
* Not receiving medication that are known to have potent aldehyde
oxidase (AO) inhibitory activity.
Washout period for medications that are known to have potent AO
inhibitory activity is 7 days prior to the first dose of study treatment.
* No prior splenectomy.
* No current or history of uveitis.
* No known uncontrolled inter-current illness including ongoing or
active infections, symptomatic congestive heart failure, conditions that
could adversely be affected by hypertension or tachycardia, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.
* No history or clinical evidence of neoplastic central nervous system
(CNS) involvement if not stable for 9 weeks prior to the first dose of
study treatment.
Note: Patients with glioblastomas are allowed if their symptoms are
stable.
* No current or history of, any seizure or seizure disorder. This includes
receiving, or having received, seizure threshold-raising medication for
the treatment of epilepsy.
In addition to the main core eligibility criteria, module specific eligibility
criteria include:
Module 1:
Patient recruited into the sequential biopsy cohorts of Part A:
* At least 1 lesion suitable for biopsy.
* Tumours that are MET gene amplified and/or mutated.
(MET gene amplified and/or mutated status defined in the laboratory
manual).
* No prior therapy with a selective MET inhibitor.
Patients recruited into Part B cohorts:
* Tumours that are MET gene amplified and/or mutated.
(MET gene amplified and/or mutated status defined in the laboratory
manual).
* At least one lesion, not previously irradiated, that can be accurately
measured at baseline.
* No prior therapy with a selective MET inhibitor.
* No co-incident malignancy that would impact on survival.
* No metastasis limited to the bone only.
Module 2:
Patient recruited into both Part A and Part B:
* Tumours that are EGFR gene mutant that are currently progressing on
treatment with a small molecule EGFR-TKI (gefitinib, erlotinib, afatinib
or osimertinib administered as per the relevant medication

Exclusion Criteria

1. Patients receiving other cancer therapy, or other investigational
product, apart from the combination agent(s) described in the relevant
combination module(s).
Note:
Bisphosphonates and granulocyte-colony stimulating factor (GCSF) are
acceptable.
Immunotherapy's such as mAbs, interferons and cytokines should not be
taken other than the combination therapy agent. Immunosuppressant's
such as cyclosporine, rapamycin, tacrolimus, rituximab, alemtuzumab,
natalizumab etc, should not be taken other than the combination therapy agent.
Hormone replacement therapy (HRT) and stable treatment of >6 months
with luteinizing hormone releasing hormone (LHRH) analogues are
acceptable.
During the study period, patients using HRT and bisphosphonates should
maintain a constant dose and should not change existing regimen.
However, if a change in HRT is indicated, e.g. due to intolerable adverse
effects, the regimen may be modified but change should be minimized
thereafter.
Washout period for cytotoxic drugs and other mAbs is 21 days prior to
the first dose of study treatment. Washout period for approved
molecular targeted non-cytotoxic drugs is 5 half-lives prior to the first
dose of study treatment.
2. Patients who have received radiotherapy for the primary tumour
within 1 week from screening visit.
3. Patients receiving medications predominantly metabolized by
CYP2B6 (refer to Section 12.1 for more information).
Washout period for medications predominantly metabolized by CYP2B6,
apart for tamoxifen, is 7 days prior to the first dose of study treatment.
Washout period for tamoxifen is 2 months prior to the first dose of study
treatment.
4. Patients receiving cannabinoid substances.
Washout period for cannabinoid substances is 5 days prior to the first
dose of study treatment.
5. Patients receiving St. John's Wort.
Washout period for St. John's Wort is 7 days prior to the first dose of
study treatment.
6. Patients receiving medications that are known to have potent AO
inhibitory activity (refer to Section 12.1 for more information).
Washout period for medications that are known to have potent AO
inhibitory activity is 7 days prior to the first dose of study treatment.
7. Patients with prior splenectomy.
8. Patients testing positive for human immunodeficiency virus (HIV)
infection, hepatitis B based on findings of persistent hepatitis B virus
surface antigen (HBsAg) or other serology test, hepatitis C virus (HCV)
or Epstein-Barr Virus (EBV) infection.
9. Patients with current, or a history of, uveitis.
10. Patients with any known uncontrolled inter-current illness including
ongoing or active infections, symptomatic congestive heart failure,
conditions that could adversely be affected by hypertension or
tachycardia, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study
requirements.
11. Patients with a history or clinical evidence of neoplastic central
nervous system (CNS) involvement if not stable for 9 weeks prior to the
first dose of study treatment.
Note: Patients with glioblastomas are allowed if their symptoms are
stable.
12. Patients with major and/or planned surgery within 12 weeks of the
first dose of study treatment.
13. Patients with any known severe allergies (e.g., anaphylaxis) to any
active o

Study & Design

• Study Type: Interventional
• Study Design: Not specified