SODIUM TRANS-[TETRACHLOROBIS(1H-INDAZOLE)RUTHENATE(III) DIHYDRATE for Colorectal cancer|Gastric cancer|Cholangiocarcinoma|Advanced solid gastrointestinal tumours|Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Be 18 years or older.\n- Have adequate organ function, defined as: - Hematologic: ANC ≥ 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count ≥ 100 x 109/L - Hepatic: total bilirubin ≤ 1.5 x ULN; transaminases ≤ 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases), ALP ≤ 2.5 x ULN - Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min. - Urine protein is 0, trace, or +1 on dipstick urinalysis, or < 1.0 gram on 24-hour urine protein analysis.\n- Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion (e.g., non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs may be initiated while the subject is participating in this study.\n- Resolved acute effects of any prior therapy to baseline severity or grade ≤1 CTCAE 5.0 except for adverse events not constituting a safety risk by investigator judgment (such as alopecia).\n- (ARM VII): BRAF wild-type tumour status.\n- Able to take oral medications (for pre-medications and supportive management).\n- Understand and be able, willing, and likely to fully comply with study procedures and restrictions.\n- Be fully informed about their illness and the investigational nature of the study protocol, and sign an approved Informed Consent Form (ICF).\n- Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.\n- Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX as standard of care per investigator judgement. Participants will have received at least one line of chemotherapy in the metastatic setting (in the dose escalation phase only). For the dose expansion phase, the setting will vary based on the malignancy. Colorectal cancer: Patients must have received at least 1 prior line of therapy prior to enrollment in this study. Pancreatic cancer: Patients must have received at least 1 prior line of therapy. Gastric cancer: Patients who have not received prior treatment may be included in this study. Cholangiocarcinoma: Patients must have received at least 1 prior line of therapy (with gemcitabine-based chemotherapy). Colorectal cancer (ARM VI): Patients must have received at least 2 prior lines of therapy prior to enrollment in this study, one of which was a 5-FU based regimen. Colorectal cancer (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting prior to erollment in this study. Prior oxaliplatin therapy is permitted in the following two situations: 1. patients who have received oxaliplatin in the adjuvant setting. 2. patients who have received oxaliplatin in the first line metastatic setting but did not progress on treatment or within 3 months of oxaliplatin treatment cessation.\n- Have measurable disease according to RECIST v1.1 (at least one measurable lesion).\n- Have an anticipated survival of at least 16 weeks.\n- Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1."}

Exclusion criteria

• {"criterion_text":"- Neuropathy > grade 2\n- Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.\n- Treatment with radiation therapy or surgery within 1 month prior to study entry.\n- Recent history of weight loss > 10% of current body weight in past 3 months.\n- Current (within 1 week of the start of the study) or regular use of any medication (including OTC, herbal or homeopathic preparations) that could affect (improve or worsen) the cancer being studied, or could affect the action or disposition of BOLD-100, or its clinical or laboratory assessment, e.g., Coumadin therapy, due to high competitive protein binding. Subjects taking ANY supplemental IRON, i.e., therapeutic or as part of a multivitamin regimen, are excluded from this study, whether prescribed or self-medicated.\n- HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.\n- Any condition potentially decreasing compliance to study procedures. Concurrent use of another investigational therapy or anti-cancer therapy.\n- Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.\n- Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin\n- (ARM VII): Prior exposure to BOLD-100\n- (ARM VII): Patients considered resitant to Oxaliplatin: Patients who have received oxaliplatin in the adjuvat setting who have progressed / relapsed within 6 months of their last oxaliplatin administration. Patients with advanced colorectal cancer who have progressed (based on RECIST 1.1) while on or within 3 months of their last administration of oxaliplatin.\n- (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours\n- (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)\n- Cerebrovascular accident within the past 6 months.\n- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam.\n- Any serious medical conditions that might be aggravated by treatment or limit compliance. This includes, but is not limited to uncontrolled psychiatric disorders, serious infections, active peptic ulcer disease and bleeding diathesis\n- Any history of serious cardiac illness including (but not confined to): o Previous or active myocardial infarction < 6 months o Congestive cardiac failure (NYHA III or IV) o History of unstable angina pectoris < 6 months o Recent coronary artery bypass grafting < 6 months o Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) o Ventricular arrhythmia < 6 months o Left ventricular ejection fraction (LVEF) < 50% as measured either by radionuclide angiography or echocardiogram o QTc interval > 470 msec\n- Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months.\n- Any other known malignancy within 3 years before the start of treatment (with the exception of non-melanoma skin cancer that had undergone curative treatment, cervical cancer in situ, or ductal/lobular carcinoma in situ of the breast that has underwent local treatment.\n- Active gastrointestinal tract disease with malabsorption syndrome.\n- Dihydropyrimidine Dehydrogenase (DPD) deficiency (Note: when tested/required prior to administration of 5-fluorouracil (5-FU) as per Principal Investigator’s best medical judgement and based on the local practice guidelines and 5-FU local prescribing instructions. In the EU, DPD testing is required, while in other countries it may be recommended).\n- Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD).\n- Currently breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0;","definition_or_measurement_approach":"Assessed and graded according to NCI CTCAE Version 5.0."}
• {"endpoint_text":"- Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;","definition_or_measurement_approach":"Incidence measured by standard SAE reporting procedures (SAE and SUSAR reporting)."}
• {"endpoint_text":"- Incidence of dose-limiting toxicities (DLT);","definition_or_measurement_approach":"Incidence of DLTs as defined by the study (DLT assessment described in protocol); used for dose-escalation decisions."}
• {"endpoint_text":"- Clinically significant changes from baseline in: - Laboratory evaluations (chemistry, hematology, coagulation, urinalysis); - Electrocardiograms; - Vital signs; - Physical examinations; - Eastern Cooperative Oncology Group (ECOG) performance status","definition_or_measurement_approach":"Clinically significant changes assessed by laboratory tests, ECGs, vital signs, physical exams and ECOG performance status compared to baseline."}
• {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall Response Rate (ORR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

76

Number Of Sites

3

Number Of Participants

16

Italy

Earliest CTIS Part Ii Submission Date

02-02-2026

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

30

Number Of Sites

3

Number Of Participants

14

Germany

Earliest CTIS Part Ii Submission Date

30-01-2026

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

7

Number Of Sites

2

Number Of Participants

12

Ireland

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

14

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

Bold Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Canada

Third parties

• {"country":"France","full_name":"Translational Research In Oncology EURL","duties_or_roles":"EU Legal Representative","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Translational Research In Oncology","duties_or_roles":"Codes: 1,12,13,15,2,6,8; 15: EU Legal Representative","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Canada","full_name":"Eve Technologies Corporation","duties_or_roles":"Pharmacodynamics (PD) Analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"GBA Central Lab Services GmbH","duties_or_roles":"Exploratory Sample Collection and Storage","organisation_type":"Laboratory/Research/Testing facility"}