Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer

NCT03883802 | Unknown Phase 2 DMC

• 2 other identifiers: SMS-0472B2018-003074-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II study investigating the safety, tolerability and effect on disease reccurence of Foxy-5 as neo-adjuvant therapy in resected colon cancer patients treated with FOLFOX chemotherapy regimen. It is a two-arm study and patients will be randomised to receive either standard therapy (surgery + FOLFOX 6 months regimen) or standard therapy + neo-adjuvant administration of Foxy-5 prior to- and following surgery (maximum of 39 administrations) until initiation of FOLFOX therapy.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The incidence of adverse events (AEs) related to Foxy-5 administration of Grade 3 and higher according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) and the Clavien-Dindo classification of surgical complications. cancer.

  From date of randomization until 28 days after the last dose of Foxy-5, assessed up to 120 days

• ctDNA as surrogate marker for disease free period

  The level of ctDNA in plasma of subjects with Wnt-5a low colon cancer as a surrogate parameter for disease recurrence in subjects with Wnt-5a low colon cancer treated with Foxy-5 compared to subjects with Wnt-5a low colon cancer who are in the Control Arm.

  2 years after resection of colon cancer

Secondary Outcomes (4)

• Overall survival

  2 years after resection of tumour

• Disease-Free Survival

  2 years after resection of tumour

• Recurrence-Free Interval

  study start to 2 years after resection of tumour

• ctDNA in Wnt-5a high patients

  2 years after resection of tumour

Other Outcomes (1)

• Thymidine Kinase activity

  1 year after resection of tumour

Study Arms (2)

Foxy-5

EXPERIMENTAL

Arm will receive Foxy-5 as neo-adjuvant therapy prior to surgical removal of tumour and afterwards until initiation of FOLFOX 6 months regimen

Drug: Foxy-5; Drug: FOLFOX regimen; Procedure: Tumour resection (colon cancer surgery)

Standard therapy

ACTIVE COMPARATOR

Surgical removal of tumour followed by 6 months FOLFOX regimen

Drug: FOLFOX regimen; Procedure: Tumour resection (colon cancer surgery)

Interventions

Foxy-5 DRUG

Lyophilized powder for solution for intravenous infusion

Foxy-5

FOLFOX regimen DRUG

6 months treatment regimen

Foxy-5; Standard therapy

Tumour resection (colon cancer surgery) PROCEDURE

Surgical removal of patients colon cancer

Foxy-5; Standard therapy

Eligibility Criteria

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

You may qualify if:

• Ability to understand and willingness to provide written informed consent before any trial-related activities.
• years of age or older.
• Male or female subjects with adenocarcinoma of the colon, judged by CT or MRI as either one of the following stages per TNM classification of colon cancer (8th edition, 2017):
• T1-4, N1-2, M0 or T4, N0, M0 and who are considered to fulfil the local criteria for adjuvant post- operative chemotherapy after scheduled surgery.
• Scheduling of surgery according to local practice allows at least 9 pre- surgery administrations of Foxy-5 for the subject. (Please note: surgery should not be postponed for trial purposes.)
• Sexually active women of childbearing potential (WOCBP) and males with WOCBP partners who are randomized to the Foxy-5 Arm must use a highly effective method of contraception for the treatment duration and for 28 days after last Foxy-5.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Clinical laboratory values at screening:
• Absolute neutrophil count ≥1.5 x 109/L
• Haemoglobin ≥ 9 g/dL
• Platelets ≥ 100 x 109/L
• Aspartate Transaminase (AST) and Alanine Transaminase (ALT)
• ≤1.5x Upper Limit of Normal (ULN)
• Serum bilirubin ≤1.5 x the ULN
• Creatinine clearance \>60 mL/min (determined by Cockcroft-Gault Equation).

You may not qualify if:

• Assessed as not suitable or unable to tolerate adjuvant chemotherapy.
• Evidence of distant metastatic (M1) disease at Screening (N1-2 is allowed).
• Any surgery (except tumour biopsy) or therapy with immune suppressive agents or bone marrow stimulating factors within the last two weeks prior to randomization.
• Any active infection requiring IV antibiotic treatment at the time of screening.
• History of hematologic or primary solid tumour malignancy.
• Pregnant or breastfeeding women.
• Currently participating in another trial and receiving trial therapy or received investigational therapy within 4 weeks of the first dose of Foxy-5.
• Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial or current drug or substance abuse.
• Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
• Unlikely to comply with the protocol requirements, instructions and trial-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.
• Legal incapacity or limited legal capacity.
• Any condition, which results in an undue risk for the subject during the trial participation according to the Investigator.

Sponsors & Collaborators

• WntResearch AB: lead
• SMS-Oncology BV: collaborator
• SAGA diagnostics AB: collaborator
• Unilabs A/S: collaborator
• BioVica AB: collaborator
• Institut Català d'Oncologia: collaborator

Study Sites (1)

Instituto de Investigación Sanitaria INCLIVA

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Foxy-5 peptide; Folfox protocol

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ramon Salazar, MD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-arm study, 1 to 1 randomization: treatment group and standard therapy

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: March 21, 2019
• Study Start: April 12, 2019
• Primary Completion: December 14, 2024
• Study Completion: December 14, 2024
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

ES (1)