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Small Molecule

BOLD-100 + FOLFOX for Advanced Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Bold Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 years or older
Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Must not have
Any history of serious cardiac illness including (but not confined to): Previous or active myocardial infarction < 6 months before the start of treatment; Congestive cardiac failure (NYHA III or IV); History of unstable angina pectoris < 6 months before the start of treatment; Recent coronary artery bypass grafting < 6 months before the start of treatment; Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg); Ventricular arrhythmia < 6 months before the start of treatment; Left ventricular ejection fraction (LVEF) < 50% as measured either by radionuclide angiography or echocardiogram; QTc interval > 470 msec; Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment; 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; Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment; Recent history of weight loss > 10% of current body weight in past 3 months before the start of treatment; 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; 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
Cerebrovascular accident within the past 6 months before the start of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety of a new ruthenium-based drug, BOLD-100, when combined with a standard chemotherapy regimen. The drug will be given intravenously, and the trial will first assess safety in a small group of patients before expanding to a larger group.

Who is the study for?
Adults with certain advanced solid tumors (pancreatic, stomach, bile duct, colorectal) who've had previous chemotherapy can join this trial. They must be expected to live at least 16 weeks, have measurable disease, good organ function and performance status. Pregnant women and those with serious medical conditions or recent surgeries are excluded.
What is being tested?
The trial is testing BOLD-100 combined with FOLFOX chemotherapy in patients with specific gastrointestinal cancers. It starts by slowly increasing the dose to find a safe level before giving it to more people to see how well it works.
What are the potential side effects?
Possible side effects include reactions related to the infusion of BOLD-100 or FOLFOX such as nausea, fatigue, blood count changes, nerve damage (neuropathy), and allergic reactions. Organ-specific inflammation might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can move around and my health is good enough for most activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a stroke in the last 6 months.
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I have or had brain metastases or tumors in the lining of my brain.
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My neuropathy is mild or I don't have it.
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I do not have any serious health conditions that could worsen with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups
Experimental Treatment
Active Control
Group I: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group II: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group III: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group IV: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group V: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group VI: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group VII: Part A - Dose Escalation - Pancreatic CancerExperimental Treatment1 Intervention
Arm closed to enrollment.
Group VIII: Part A - Dose Escalation - Gastric CancerExperimental Treatment1 Intervention
Arm closed to enrollment.
Group IX: Part A - Dose Escalation - Colorectal CancerExperimental Treatment1 Intervention
Arm closed to enrollment.
Group X: Part A - Dose Escalation - CholangiocarcinomaExperimental Treatment1 Intervention
Arm closed to enrollment.
Group XI: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VII) - RandomizedActive Control1 Intervention
Arm open to enrollment.

Find a Location

Who is running the clinical trial?

Bold Therapeutics, Inc.Lead Sponsor

Media Library

BOLD-100 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04421820 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VII) - Randomized, Part B - Dose Expansion - 1L Gastric Cancer (ARM I), Part B - Dose Expansion - 2L Gastric Cancer (ARM II), Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III), Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV), Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI), Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V), Part A - Dose Escalation - Gastric Cancer, Part A - Dose Escalation - Pancreatic Cancer, Part A - Dose Escalation - Colorectal Cancer, Part A - Dose Escalation - Cholangiocarcinoma
Colorectal Cancer Clinical Trial 2023: BOLD-100 Highlights & Side Effects. Trial Name: NCT04421820 — Phase 1 & 2
BOLD-100 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04421820 — Phase 1 & 2
~54 spots leftby Jun 2026
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