A study of tucatinib with trastuzumab and mFOLFOX6 versus standard of care treatment in first-line HER2+ metastatic colorectal cancer.

Phase 1

• Conditions: nresectable or metastatic HER2+ colorectal cancer.; MedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002672-40-IT
• Lead Sponsor: SEAGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-09
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Have histologically and/or cytologically documented adenocarcinoma of the colon or rectum, which is metastatic and/or unresectable
2. Subjects must be willing and able to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks obtained prior to treatment initiation, to a sponsor-designated central laboratory for biomarker analysis. If archival tissue is not available, then a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to the Cycle 1 Day 1 timeframe. Biopsy must provide adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.
3. Have HER2+ disease as determined by tissue-based investigational HER2 IHC and ISH assays performed at a sponsor-defined central laboratory. HER2 amplification will be determined using ASCO/CAP guidelines for gastric and gastroesophageal cancer with IHC 3+ or IHC 2+/ISH+ result.
4. Have RAS WT disease as determined by local or central testing (if local testing is unavailable or is not preferred)
6. Have radiographically measurable disease per RECIST v1.1 according to INV assessment, with at least one site of disease that is measurable
and that has not been previously irradiated; or, if the subject has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
7. Have ECOG Performance Status (PS) of 0 or 1
15. CNS Inclusion: a.No evidence of brain metastases; b.Previously treated brainmetastases which are asymptomatic.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Have previously received any systemic anticancer therapy for CRC in the metastatic setting or have participated in any interventional clinical trial for CRC in the metastatic setting. Subjects may have received prior chemotherapy for CRC in the adjuvant setting provided that it was completed >6 months prior to enrollment.
2. Have previously received radiation therapy within 14 days prior to enrollment(or within 7 days in the setting of SRS). Subjects who have
received prior radiation therapy must have recovered to baseline from any treatment-related adverse events (AEs). Subjects who have received
palliative radiotherapy for symptomatic metastases may enter the study without a washout period provided that the subject has recovered from
any treatment-related AEs.
3. Have previously been treated with anti-HER2 therapy
8. Have ongoing >or= Grade 2 diarrhea of any etiology at screening
15. Inability to swallow pills or any significant GI disease which would preclude the adequate oral absorption of medications
19. Subjects with active CNS metastases (irradiated or resected lesions are permitted). See Inclusion Criteria for details. Subjects with carcinomatous meningitis are excluded without exception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified