Colorectal Cancer Clinical Trial
Official title:
A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations
This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | December 31, 2025 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent by patients = 18 years of age and, assent for patients = 12 up to < 18 years of age - Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1) - Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required - If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging (Closed to Enrollment) Substudy A-specific inclusion criterion: - Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Substudy B-specific inclusion criterion: - Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Exclusion Criteria: - Known presence of concurrent activating mutation - Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO) (Closed to Enrollment) Substudy A-specific exclusion criterion: - Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Medical Centre | Clayton | Victoria |
Belgium | Antwerp University Hospital | Edegem | |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | The Hospital for Sick Children | Toronto | Ontario |
France | Hopital de La Timone - APHM | Marseille | Bouches-du-Rhône |
Korea, Republic of | Dong-A University Hospital | Busan | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Spain | Hospital Clinic Barcelona | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Community North Cancer Center | Indianapolis | Indiana |
United States | Cancer Specialists of North Florida | Jacksonville | Florida |
United States | The Angeles Clinic | Los Angeles | California |
United States | Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Hoag Health | Newport Beach | California |
United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Day One Biopharmaceuticals, Inc. |
United States, Australia, Belgium, Canada, France, Korea, Republic of, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1b: Determine the safety of tovorafenib in combination with other therapies | Incidence and severity of adverse events | Up to 48 months | |
Primary | Phase 1b: Determine the MTD and RP2D of tovorafenib in combination with other therapies | Incidence and severity of adverse events | Up to 48 months | |
Primary | Phase 2: Evaluate the efficacy of tovorafenib monotherapy or in combination with other therapies | Overall response rate (ORR) as assessed by the proportion of patients with the best overall confirmed response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 48 months | |
Secondary | Phase 1b: Assess efficacy of tovorafenib in combination with other therapies | Duration of response (DOR) in patients with best overall response of CR or PR | Up to 48 months | |
Secondary | Phase 1b & 2: Assess additional efficacy parameters of tovorafenib alone and in combination with other therapies | Duration of progression-free survival (PFS) and overall survival (OS) | Up to 48 months | |
Secondary | Phase 1b & 2: Characterize tumor responses observed with tovorafenib alone and in combination with other therapies | Time to response (TTR) in patients with best overall response of CR or PR; and comparing the DOR in patients with CR or PR with the DOR observed with the immediate prior line of anticancer treatment | Up to 48 months | |
Secondary | Phase 1b & 2: Characterize the pharmacokinetic (PK) profile of tovorafenib alone and in combination with other therapies | Measure plasma concentration of tovorafenib | Up to 48 months | |
Secondary | Phase 1b & 2: Characterize the pharmacodynamic (PD) profile of tovorafenib alone and in combination with other therapies | Evaluate changes from baseline of phosphorylated ERK and other relevant biomarkers | Up to 48 months | |
Secondary | Phase 2: Assess the safety and tolerability of tovorafenib as monotherapy, or in combination with other therapies | Incidence and severity of adverse events | Up to 48 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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