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BOLD-100 in Combination with FOLFOX for the Treatment of Advanced Solid Tumours
EU CTIS ID: 2024-517500-11-00
What this study is testing
PART A (Dose Escalation): To assess the safety, tolerability and Maximum Tolerated Dose (MTD) of FOLFOX standard-of-care (FOLFOX SOC) combination chemotherapy + BOLD-100 in advanced solid tumours. PART B (Dose Expansion Phase): To assess response rates to SOC combination chemotherapy + BOLD-100 in advanced solid tumours.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Be 18 years or older.
- 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.
- 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.
- 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).
- (ARM VII): BRAF wild-type tumour status.
- Able to take oral medications (for pre-medications and supportive management).
You likely can't join if
- Neuropathy > grade 2
- (ARM VII): Prior exposure to BOLD-100
- (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
- (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
- Cerebrovascular accident within the past 6 months.
- 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.
See the full eligibility criteria
Who can join
- Be 18 years or older.
- 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.
- 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.
- 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).
- (ARM VII): BRAF wild-type tumour status.
- Able to take oral medications (for pre-medications and supportive management).
- Understand and be able, willing, and likely to fully comply with study procedures and restrictions.
- Be fully informed about their illness and the investigational nature of the study protocol, and sign an approved Informed Consent Form (ICF).
- Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
- 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.
- Have measurable disease according to RECIST v1.1 (at least one measurable lesion).
- Have an anticipated survival of at least 16 weeks.
- Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
What rules you out
- Neuropathy > grade 2
- (ARM VII): Prior exposure to BOLD-100
- (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
- (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
- Cerebrovascular accident within the past 6 months.
- 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.
- 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
- 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
- Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months.
- 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.
- Active gastrointestinal tract disease with malabsorption syndrome.
- Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
- (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.
- Currently breastfeeding
- 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).
- Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD).
- Treatment with radiation therapy or surgery within 1 month prior to study entry.
- Recent history of weight loss > 10% of current body weight in past 3 months.
- 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.
- HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
- Any condition potentially decreasing compliance to study procedures. Concurrent use of another investigational therapy or anti-cancer therapy.
- Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
- Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.