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Taking people in CanadaPhase 1/2

Tests BOLD-100 with FOLFOX chemotherapy in advanced solid tumours

Tests BOLD-100 with FOLFOX chemotherapy in adults with advanced solid tumours.

Key facts

Who runs it
Bold Therapeutics, Inc.
Where
Edmonton, Hamilton, Montreal, Ottawa, and Toronto, CanadaSee the 6 sitesAlso in 7 other countries, 22 sites
Registry title
BOLD-100 in Combination With FOLFOX With or Without Bevacizumab for the Treatment of Advanced, Solid Tumours
Status
Recruiting
Phase
Phase 1/2
People taking part
220 people, planned
Started
28 Aug 2020
Expected to end
31 Dec 2027
Type of study
Interventional, 9 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)
  • BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced gastrointestinal tumours that have spread or cannot be removed by surgery, who are going to receive FOLFOX with or without bevacizumab.

Age
18 years or older
Sex
All sexes can join. Women must not be pregnant and must agree to follow the contraception rules of the trial.
Disease stage
Gastrointestinal tumours confirmed by tissue or cell tests that are metastatic or cannot be removed by surgery. The disease must be measurable by RECIST v1.1. Expected survival is at least 16 weeks. ECOG performance score is 0 or 1.
Earlier treatment
For Arm VII only: people must have had only 1 earlier line of treatment for metastatic disease, and no earlier BOLD-100. Nobody can join if they had another trial drug or anti-cancer treatment in the last 4 weeks, or radiation or surgery in the last 4 weeks.
Biomarker or test result
For Arm VII only: the tumour must be BRAF wild-type. Tumours that are microsatellite-high (MSI-H) cannot join Arm VII.

Main reasons for not taking part

  • Nerve damage (neuropathy) worse than grade 2
  • Cancer in the brain or around the brain and spinal cord (CNS metastasis or leptomeningeal tumours)
  • Any serious heart illness in the past
  • Stroke in the last 6 months, or serious bleeding in the last 6 months
  • Dihydropyrimidine Dehydrogenase (DPD) deficiency, or breastfeeding

The registry criteria, word for word

Show all 30 criteriaShow less

Who can take part

  • Be 18 years or older
  • 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 ± Bevacizumab. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting
  • Have measurable disease according to RECIST v1.1
  • Have an anticipated survival of at least 16 weeks
  • Be ambulatory, with an ECOG performance score of 0 or 1
  • Have adequate organ function
  • Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion
  • Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF)
  • (ARM VII): BRAF wild-type tumour status

Who cannot take part

  • Previous intolerance to or significant reaction secondary to fluorouracil, oxaliplatin, or bevacizumab
  • Cerebrovascular accident within the past 6 months before the start of treatment
  • Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment
  • 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
  • Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment
  • Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
  • (ARM VII): Prior exposure to BOLD-100
  • Any serious medical conditions that might be aggravated by treatment or limit compliance
  • Any history of serious cardiac illness
  • Any other known malignancy within 3 years before the start of treatment
  • Active gastrointestinal tract disease with malabsorption syndrome
  • Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
  • HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent
  • (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
  • Neuropathy > grade 2
  • History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours
  • Currently breastfeeding
  • Dihydropyrimidine Dehydrogenase (DPD) deficiency
  • (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours

Where in Canada

Also in 7 other countries, 22 sites

  • Cross Cancer InstitueEdmonton, CanadaContact: Carly MackTaking people
  • Juravinski Cancer CentreHamilton, CanadaContact: Carrie FergusonTaking people
  • Jewish General HospitalMontreal, CanadaContact: Yacine TchemmounTaking people
  • McGill University Health Centre Glen SiteMontreal, CanadaContact: Wafaa ChebaroTaking people
  • The Ottawa Hospital Cancer CentreOttawa, CanadaContact: Saara AliTaking people
  • Princess Margaret Cancer CentreToronto, CanadaContact: Mopina ShrikumarTaking people

About the trial

What the trial wants to find out

BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX ± Bevacizumab chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase. This study now includes as a treatment intervention the SOC combination FOLFOX ± Bevacizumab, if indicated.

The 9 groups in the trial

  • Part B - Dose Expansion - 1L Gastric Cancer (ARM I)Treatment being tested

    Arm closed to enrollment.

    Treatment: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

  • Part B - Dose Expansion - 2L Gastric Cancer (ARM II)Treatment being tested

    Arm closed to enrollment.

    Treatment: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

  • Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)Treatment being tested

    Arm closed to enrollment.

    Treatment: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

  • Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)Treatment being tested

    Arm closed to enrollment.

    Treatment: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

  • Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)Treatment being tested

    Arm closed to enrollment.

    Treatment: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

  • Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)Treatment being tested

    Arm closed to enrollment.

    Treatment: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

  • Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA)Existing treatment, for comparison

    Arm open to enrollment. 500 mg/m2 BOLD-100 + SOC (FOLFOX ± Bevacizumab)

    Treatment: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)

  • Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB)Existing treatment, for comparison

    Arm open to enrollment. 625 mg/m2 BOLD-100 + SOC (FOLFOX ± Bevacizumab)

    Treatment: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)

  • Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC)Existing treatment, for comparison

    Arm open to enrollment. FOLFOX ± Bevacizumab alone.

    Treatment: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy With or Without Bevacizumab in Patients With Advanced Solid Tumours
Plain-language title
Tests BOLD-100 with FOLFOX chemotherapy in advanced solid tumoursGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 October 2026