Colorectal CancerPhase 1/2NCT04421820
BOLD-100 in Combination With FOLFOX With or Without Bevacizumab for the Treatment of Advanced, Solid Tumours
A Phase 1/2 study testing BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII) and BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) in people with Colorectal Cancer and Pancreatic Cancer, run by Bold Therapeutics, Inc. at 28 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer, Gastric Cancers
- What is being tested?
- BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII) and BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 28 Aug 2020to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- Neuropathy > grade 2
- Previous intolerance to or significant reaction secondary to fluorouracil, oxaliplatin, or bevacizumab.
- Cerebrovascular accident within the past 6 months before the start of treatment.
- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
- Any serious medical conditions that might be aggravated by treatment or limit compliance.
- Any history of serious cardiac illness.
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- 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.
- 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.
- HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
- Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
- Currently breastfeeding
- Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
- (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)
Trial locations and contacts
28 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 8 countries
Canada6 sites, 6 recruiting
- Recruiting
Cross Cancer Institue
Edmonton, Alberta
Carly Mack, 780-432-8823, Carly.Mack@ahs.ca
Lindzie Sinclair, Lindzie.Sinclair@ahs.ca
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario
Carrie Ferguson, 905-521-2100 ext. 64416, Fergusonca@hhsc.ca
Stephanie Skeldon, Skeldon@hhsc.ca
- Recruiting
Jewish General Hospital
Montreal, Quebec
Yacine Tchemmoun, Yacine.Tchemmoun.ccomtl@ssss.gouv.qc.ca
Ewa Forczek, 514-340-8222, Ewa.Forczek.ccomtl@ssss.gouv.qc.ca
- Recruiting
McGill University Health Centre Glen Site
Montreal, Quebec
Wafaa Chebaro, Wafaa.Chebaro@muhc.mcgill.ca
Zak Dembele, Aboudrazako.Dembele@muhc.mcgill.ca
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Saara Ali, 613-737-7700 ext. 70211, saali@ohri.ca
Rose Leclerc, 613-737-7700 ext. 70303, roleclerc@ohri.ca
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Mopina Shrikumar, Mopina.Shrikumar@uhn.ca
Cynthia Bocaya, 416-946-4501 ext. 4713, Cynthia.Bocaya@uhn.ca
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center
Goyang
Min Ji Kim, 12991@ncc.re.kr
Yeon Hee Lee, 010-7109-6752, Yunsoo86@ncc.re.kr
- Recruiting
Kangbuk Samsung Hospital
Seoul
Min Ju Cho, +82 2 2001 1526, m0360.Cho@samsung.com
Ji Won Lee, +82 2 2001 1578, Jiwon.Lee@samsung.com
- Recruiting
Samsung Medical Center
Seoul
Yeong Seo, +82 2 2148 9848, yeonog.seo@sbri.co.kr
- Recruiting
Seoul National University Hospital
Seoul
Hyang mi Kang, (+)82 2 6072 5172, 49001@snuh.org
- Recruiting
Severance Hospital - Yonsei University
Seoul
Anna Yeun, annay@yuhs.ac
United Kingdom4 sites, 4 recruiting
- Recruiting
Velindre Cancer Centre Clinical Trials
Cardiff
Sam Morgan, +44 29 2061 5888, Sam.Morgan@wales.nhs.uk
Richard Adams
- Recruiting
Ulster Hospital
Dundonald, BT16 1RH
Rachel Boyd, 02890 550427 ext. 10206, Rachael.Boyd2@setrust.hscni.net
Sandra Van Schaeybroeck, Dr
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
Niamh Wood, +44 20 3186 5177, Niamh.Wood@rmh.nhs.uk
Hazel Lote, Dr
- Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
Niamh Wood, +44 20 3186 5177, Niamh.Wood@rmh.nhs.uk
Hazel Lote, Dr
Ireland3 sites, 3 recruiting
- Recruiting
Mater Miserecordiae University Hospital
Dublin
Austin Duffy, austin.duffy@startdublin.com
Niamh Ni Obain, Niamh.obain@startdublin.com
- Recruiting
St. James Hospital
Dublin
Emily Harrold, Dr, +353 1 410 3000, eharrold@stjames.ie
Trisha Lima, TLima@stjames.ie
- Recruiting
St. Vincent's University Hospital
Dublin
Fergus Keane, ferguskeane@svhg.ie
Fausta Barizaite, fausta.barizaite@ccrt.ie
Italy3 sites, 3 recruiting
- Recruiting
Fondazione IRCCS "Istituto Nazionale dei Tumori
Milan
Federica Morano, 390223903807, Federica.Morano@istitutotumori.mi.it
Federica Morano
- Recruiting
AOU L. Vanvitelli
Naples
Stefania Napolitano, 393287269612, stefania.napolitano@unicampania.it
Stefania Napolitano
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
Chiara Cremolini, 39050993173, chiaracremolini@gmail.com
Chiara Cremolini
Spain3 sites, 3 recruiting
- Recruiting
Vall Hebron Institute of Oncology (VHIO)
Barcelona
Elena Elez, 34 932746000, meelez@vhio.net
Elena Elez
- Recruiting
Early Phase Unit FJD START Madrid
Madrid
Manuel Pedregal Trujillo, 34 660559027, manuel.pedregal@startmadrid.com
Manuel Pedregal Trujillo
- Recruiting
Hospital 12 de Octubre
Madrid
Jorge Barriuso, 34 913908926, jorge.barriuso.imas12@h12o.es
Jorge Barriuso
United States2 sites
- Completed
University of California, Los Angeles
Santa Monica, California, 90095
- Completed
Moffitt Cancer Center
Tampa, Florida, 33612
Germany2 sites, 2 recruiting
- Recruiting
Universitatsklinikum Bonn
Bonn
Maria Gonzalez-Carmona, +49 228 287 17014, Maria.Gonzalez-Carmona@ukbonn.de
Maria Gonzalez-Carmona
- Recruiting
University Hospital of Ulm
Ulm
Thomas Seufferlein, +49 731 500 44501, thomas.seufferlein@uniklinik-ulm.de
Thomas Seufferlein
About this study
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
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.
Read the detailed description
BOLD-100 is a novel, targeted anti-cancer therapy which is an intravenously administered small molecule drug. In a previous Phase 1 study (NCT01415297) BOLD-100 showed low toxicity with minimal hematological issues as well as some potential anti-tumour activity. The lack of observed hematological toxicity and neurotoxicity position BOLD-100 well for use in combination with a broad range of standard-of-care (SOC) chemotherapy regimens.
This is a prospective, multicenter non-randomized Phase 1b/2a dose escalation \& expanded cohort study of BOLD-100 in patients with advanced gastrointestinal malignancies (colorectal, pancreatic, gastric cancers, and cholangiocarcinoma) receiving standard-of-care FOLFOX chemotherapy. Enrollment in Arms I - VI is closed to enrollment.
Colorectal cancer (ARM VII) for patients who are oxaliplatin naïve and have received only 1 prior line of therapy in the metastatic setting. Within this arm, participants will be randomized to one of two dose levels of BOLD-100 - either 500 mg/m2 or 625 mg/m2 in combination with FOLFOX ± Bevacizumab or FOLFOX alone, in a 1:1:1 ratio. Participants enrolled into Arm VII will complete quality of life questionnaires examining general quality of life and neuropathy associated quality of life parameters. Participants will be eligible to receive the monoclonal antibody Bevacizumab as part of the standard of care treatment regimen (FOLFOX) if indicated.
- Being tested
- BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII), BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)Drug
Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX ± Bevacizumab; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX ± Bevacizumab; Arm VIIC: FOLFOX ± Bevacizumab alone
BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Drug
BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Part B - Dose Expansion - 1L Gastric Cancer (ARM I) | Experimental | Arm closed to enrollment. Receives: Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) |
| Part B - Dose Expansion - 2L Gastric Cancer (ARM II) | Experimental | Arm closed to enrollment. Receives: Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) |
| Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III) | Experimental | Arm closed to enrollment. Receives: Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV) | Experimental | Arm closed to enrollment. Receives: Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) |
| Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V) | Experimental | Arm closed to enrollment. Receives: Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) |
| Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI) | Experimental | Arm closed to enrollment. Receives: Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA) | Active comparator | Arm open to enrollment. 500 mg/m2 BOLD-100 + SOC (FOLFOX ± Bevacizumab) Receives: Drug: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII) |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB) | Active comparator | Arm open to enrollment. 625 mg/m2 BOLD-100 + SOC (FOLFOX ± Bevacizumab) Receives: Drug: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII) |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC) | Active comparator | Arm open to enrollment. FOLFOX ± Bevacizumab alone. Receives: Drug: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events ([S]AEs)
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment
Incidence of dose-limiting toxicities (DLT)
Dose escalation only.
Measured: Screening to 4 weeks after first treatment
Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance status
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment
Progression Free Survival (PFS): Arm VII
Arm VII: Primary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Response Rate (ORR): Arm VII
Arm VII: Primary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Survival (OS): Arm VII
Arm VII: Primary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment for last patient
Secondary outcomes (7)
Progression Free Survival (PFS): Arms I-VI
Arms I-VI: Secondary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Response Rate (ORR): Arms I-VI
Arms I-VI: Secondary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Survival (OS): Arms I-VI
Arms I-VI: Secondary outcome measure
Measured: Through study completion, approximately 2 weeks after last treatment for last patient
Baseline and changes in biomarker levels during treatment
Serum GRP78
Measured: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Peak Plasma Concentrations (Cmax)
Arms I-VII
Measured: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Area under the plasma concentration versus time (AUC)
Arms I-VII
Measured: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Elimination half life (T1/2)
Arms I-VII
Measured: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start28 Aug 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Randomized - Arm VII only: Second line mCRC 500 mg/m2 or 625 mg/m2 in combination with FOLFOX ± Bevacizumab or FOLFOX alone, in a 1:1:1 ratio. Participants will be eligible to receive the monoclonal antibody Bevacizumab as part of the standard of care treatment regimen (FOLFOX) if indicated.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bold Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421820
- Sponsor's protocol ID
- BOLD-100-001
- Status last verified
- Oct 2026
- First submitted
- 26 May 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04421820
- Acronym / sponsor ID
- BOLD-100-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Bold Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BOLD-100 is a novel, targeted anti-cancer therapy which is an intravenously administered small molecule drug. In a previous Phase 1 study (NCT01415297) BOLD-100 showed low toxicity with minimal hematological issues as well as some potential anti-tumour activity. The lack of observed hematological toxicity and neurotoxicity position BOLD-100 well for use in combination with a broad range of standard-of-care (SOC) chemotherapy regimens.
This is a prospective, multicenter non-randomized Phase 1b/2a dose escalation \& expanded cohort study of BOLD-100 in patients with advanced gastrointestinal malignancies (colorectal, pancreatic, gastric cancers, and cholangiocarcinoma) receiving standard-of-care FOLFOX chemotherapy. Enrollment in Arms I - VI is closed to enrollment.
Colorectal cancer (ARM VII) for patients who are oxaliplatin naïve and have received only 1 prior line of therapy in the metastatic setting. Within this arm, participants will be randomized to one of two dose levels of BOLD-100 - either 500 mg/m2 or 625 mg/m2 in combination with FOLFOX ± Bevacizumab or FOLFOX alone, in a 1:1:1 ratio. Participants enrolled into Arm VII will complete quality of life questionnaires examining general quality of life and neuropathy associated quality of life parameters. Participants will be eligible to receive the monoclonal antibody Bevacizumab as part of the standard of care treatment regimen (FOLFOX) if indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Randomized - Arm VII only: Second line mCRC 500 mg/m2 or 625 mg/m2 in combination with FOLFOX ± Bevacizumab or FOLFOX alone, in a 1:1:1 ratio. Participants will be eligible to receive the monoclonal antibody Bevacizumab as part of the standard of care treatment regimen (FOLFOX) if indicated.
| Arm | Type | Receives |
|---|---|---|
| Part B - Dose Expansion - 1L Gastric Cancer (ARM I) | Experimental | Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Arm closed to enrollment. |
| Part B - Dose Expansion - 2L Gastric Cancer (ARM II) | Experimental | Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Arm closed to enrollment. |
| Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III) | Experimental | Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Arm closed to enrollment. |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV) | Experimental | Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Arm closed to enrollment. |
| Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V) | Experimental | Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Arm closed to enrollment. |
| Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI) | Experimental | Drug: BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Arm closed to enrollment. |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA) | Active comparator | Drug: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)Arm open to enrollment. 500 mg/m2 BOLD-100 + SOC (FOLFOX ± Bevacizumab) |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB) | Active comparator | Drug: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)Arm open to enrollment. 625 mg/m2 BOLD-100 + SOC (FOLFOX ± Bevacizumab) |
| Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC) | Active comparator | Drug: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)Arm open to enrollment. FOLFOX ± Bevacizumab alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- Neuropathy > grade 2
- Previous intolerance to or significant reaction secondary to fluorouracil, oxaliplatin, or bevacizumab.
- Cerebrovascular accident within the past 6 months before the start of treatment.
- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
- Any serious medical conditions that might be aggravated by treatment or limit compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX ± Bevacizumab; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX ± Bevacizumab; Arm VIIC: FOLFOX ± Bevacizumab alone | Drug | Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA), Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB), Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC) |
| BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy | Drug | Part B - Dose Expansion - 1L Gastric Cancer (ARM I), Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V), Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV), Part B - Dose Expansion - 2L Gastric Cancer (ARM II), Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III), Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI) |
Primary outcome
Incidence and severity of adverse events ([S]AEs)
Time frame: Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Incidence of dose-limiting toxicities (DLT)
Time frame: Screening to 4 weeks after first treatment
Dose escalation only.
Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance status
Time frame: Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Progression Free Survival (PFS): Arm VII
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
Overall Response Rate (ORR): Arm VII
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
Overall Survival (OS): Arm VII
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
7 secondary outcomes
Progression Free Survival (PFS): Arms I-VI
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Response Rate (ORR): Arms I-VI
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Survival (OS): Arms I-VI
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Baseline and changes in biomarker levels during treatment
Time frame: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Peak Plasma Concentrations (Cmax)
Time frame: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Area under the plasma concentration versus time (AUC)
Time frame: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Elimination half life (T1/2)
Time frame: Arms I-VII; Through study completion, approximately 2 weeks after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII) and BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) in people with Colorectal Cancer and Pancreatic Cancer, run by Bold Therapeutics, Inc. at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Canada, South Korea, United Kingdom, Ireland, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Jones (604-262-9899, clinical@bold-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events ([S]AEs) (time frame: Through study completion, approximately 2 weeks after last treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.