A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically

NCT05826600 | Terminated Phase 1 DMC

• 1 other identifier: OMX-0407-101
• Study Type: interventional
• Target: 68
• Locations: 3 countries
• Sites: 24

Brief Summary

The main purpose of the dose escalation phase of the study is to determine the safety of different doses of OMX-0407. The dose expansion (phase Ib) part of the study will evaluate efficacy, safety and tolerability at a dose determined in the dose escalation,

Conditions

Solid Tumor

Keywords

Renal Cell Carcinoma; Angiosarcoma

Outcome Measures

Primary Outcomes (2)

• Identify Dose Limiting Toxicities

  Incidence of dose limiting toxicities at each dose level

  4 weeks (1 cycle)

• Identify objective response rate

  Number of objective responses of OMX-0407 in patients with Renal Cell cancer, Non small cell lung cancer, urothelial cancer and angiosarcoma

  Every 12 weeks (3 cycles)

Secondary Outcomes (13)

• Maximum Tolerated Dose

  evaluated up to approximately 3 years

• Investigate the safety and tolerability of OMX-0407

  through study completion, estimated up to approximately 3 years

• Pharmacokinetics (Cmax) of OMX-0407

  evaluated up to approximately 3 years

• Pharmacokinetics (Tmax) of OMX-0407

  evaluated up to approximately 3 years

• Pharmacokinetics (AUClast) of OMX-0407

  evaluated up to approximately 3 years

Other Outcomes (3)

• Explore Target Kinase Inhibition

  evaluated up to approximately 3 years

• Explore and characterize the metabolites of OMX-0407

  evaluated up to approximately 3 years

• Explore associations of pre-treatment tumour biology with treatment outcome

  evaluated up to approximately 3 years

Study Arms (2)

OMX-0407 - Escalation Phase

EXPERIMENTAL

A starting daily dose of 20 mg OMX-0407 per participant split into twice daily 10 mg. Dose escalation will be determined by the safety monitoring committee. Dose for expansion will be determined by the safety monitoring committee.

Drug: OMX-0407

OMX-0407 - Expansion Phase (Phase Ib)

EXPERIMENTAL

A dose of 100 mg OMX-0407 will be orally administered twice daily.

Drug: OMX-0407

Interventions

OMX-0407 DRUG

Dose escalation, Dose expansion

OMX-0407 - Escalation Phase; OMX-0407 - Expansion Phase (Phase Ib)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years (≥16 years for the AS expansion cohort) and willing to provide informed consent for the study.
• Cytological or pathological confirmation of advanced cancer.
• Subjects treated in three subject cohorts onwards will be required to provide either archival tumour material or be willing to undergo a core biopsy to provide tumour material during screening.
• Subjects should have completed or be unsuitable for licensed therapies for their primary cancer unless such therapies are not available according to local practice - for example not reimbursed or included in treatment guidelines. All subjects must have received at least one previous line of systemic therapy for the tumour type under investigation. Subjects who have declined treatment or according to their treating physician are unsuitable for an existing licensed therapy are eligible for the study.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1 or 2. Subjects treated in the cohort expansion phase of the study should have an ECOG Performance status of 0 or 1.
• Able to swallow oral medication with no existing evidence of underlying gastrointestinal malabsorption or abnormal gastrointestinal transit.
• For female subjects and male partners of childbearing potential, willingness and able to use two forms of highly effective contraception methods (e.g., oral contraceptive and condom, intra-uterine device, and condom) while on study and for 30 days after the last study treatment. For male subjects and female partners of childbearing potential, willingness and able to use two forms of highly effective contraception methods (e.g., oral contraceptive and condom, intra-uterine device, and condom) while on study and for 3 months after the last study treatment. Women who last experienced menses more than one year previously or who have undergone bilateral ovariectomy, hysterectomy or tubal ligation which is documented in their medical notes do not require to use contraception during or after treatment with OMX-0407. Male subjects who have previously undergone vasectomy are not required to use contraception.
• All toxicity from previous anti-cancer therapy including radiotherapy must have recovered to either Grade I or stable Grade II (CTCAE v5).
• Subjects should have at least evaluable tumour by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Subjects treated in the Cohort Expansion phases of the study should have measurable disease.
• Prior histological confirmation of clear cell renal cell carcinoma. In the case of mixed histology in order to be eligible at least 70% of reviewed tumour should be of clear cell histology.
• Subjects with known renal vascular involvement should be on stable anticoagulation at the start of treatment with OMX-0407. Tumour/skin biopsies should be performed prior to the onset of anticoagulation.
• Previous treatment must include PD-1 blockade and VEGFR inhibition.
• Clinical and histopathological confirmation of advanced/metastatic or unresectable visceral AS, cutaneous AS secondary to radiotherapy or other cutaneous AS.
• Subjects should have progressive disease
• Subject has received at least one prior line of systemic therapy for metastatic or unresectable disease which must have included a taxane or an anthracycline.

You may not qualify if:

• Untreated CNS metastases. Subjects with CNS metastases that have completed treatment at least two weeks previously and have either an unchanging or no neurological deficit whilst not receiving corticosteroid therapy are eligible. Subjects with known CNS metastases must have received CNS directed therapy and not systemic therapy alone to be eligible for the study.
• Either Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 2.5 upper limit of normal (ULN) unless in the presence of hepatic metastases when AST or ALT as high as 5 ULN is acceptable. Serum bilirubin \> 1.5 ULN unless in the presence of hepatic metastases when serum bilirubin as high as 3 x ULN is acceptable. Subjects with isolated increases in alkaline phosphatase (ALK) are eligible for the study.
• Prothrombin Time or equivalent such as international normalized ratio (INR) or the Quick test \> 1.5 ULN.
• Activated Partial Thromboplastin Time (PTT) \> 1.5 ULN.
• Chronic anticoagulant therapy that cannot be discontinued for tumour biopsy if necessary.
• Previous biological or unlicensed anticancer therapy within five half-lives or thirty days of treatment - whichever is shortest.
• Prior cytotoxic chemotherapy in the preceding three weeks.
• Persistent fever or other signs of uncontrolled infection.
• Creatinine clearance by Cockcroft-Gault formula or local equivalent \< 30 ml/min.
• Allergy to OMX-0407 or any of its excipients.
• Personal or family history of long QT syndrome or sudden death.
• Family or personal history of ventricular arrythmia. Known untreated aberrant preexcitation pathways such as Wolf-Parkinson-White syndrome. Ongoing atrial fibrillation unless the ventricular rate is controlled by medical therapy.
• Unstable hypertension requiring changes in antihypertensive medication within the preceding three months, Myocardial Infarction or Cerebrovascular accident within the preceding three months. Cardiac failure New York Heart Association (NYHA) Grade III or IV.
• Abnormal echocardiogram (ECHO) according to investigational site criteria including a normal Ejection Fraction.
• QTc interval after Fridericia correction of greater than 450 ms (man) or 460 ms (woman) (mean of three readings performed at least five minutes apart).

Sponsors & Collaborators

• iOmx Therapeutics AG: lead

Study Sites (24)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

ZAS Augustinus Afdeling Oncologische Research

Wilrijk, 2610, Belgium

Location

UNICANCER-Institut Bergonie - Nouvelle-Aquitaine

Bordeaux, France

Location

Universite de Lyon - Centre Leon-Berard (CLB)

Lyon, France

Location

Assistance Publique Hopitaux de Marseille- Hopital de La Timone

Marseille, France

Location

Institut du Cancer Montpellier (ICM)

Montpellier, France

Location

Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

Nantes, France

Location

UNICANCER - Centre Oscar Lambret

Nantes, France

Location

Gustave Roussy - Institut Gustave Roussy

Paris, France

Location

CHU de Toulouse

Toulouse, France

Location

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d'Hebrón

Barcelona, 08035, Spain

Location

NEXT Oncology - Hospital Quironsalud Barcelona

Barcelona, Spain

Location

Hospital Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Clínica Universidad de Navarra

Madrid, 28027, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

START Madrid - Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Centro Integral Oncológico Clara Campal

Madrid, 28050, Spain

Location

NEXT Oncology - Hospital Universitario Quironsalud

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital La Fe de Valencia

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Hemangiosarcoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Vascular Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 24, 2023
• Study Start: March 30, 2023
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 24, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

ES (12); BE (4); FR (8)