NCT04421820

Brief 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. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_1 colorectal-cancer

Timeline
4mo left

Started Aug 2020

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach
5 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Aug 2020Sep 2026

First Submitted

Initial submission to the registry

May 26, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

May 26, 2020

Last Update Submit

April 30, 2026

Conditions

Colorectal CancerPancreatic CancerGastric CancersCholangiocarcinoma

Outcome Measures

Primary Outcomes (6)

  • Incidence and severity of adverse events ([S]AEs)

    Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure

    Through study completion, approximately 2 weeks after last treatment

  • Incidence of dose-limiting toxicities (DLT)

    Dose escalation only.

    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

    Through study completion, approximately 2 weeks after last treatment

  • Progression Free Survival (PFS): Arm VII

    Arm VII: Primary outcome measure

    Through study completion, approximately 2 weeks after last treatment for last patient

  • Overall Response Rate (ORR): Arm VII

    Arm VII: Primary outcome measure

    Through study completion, approximately 2 weeks after last treatment for last patient

  • Overall Survival (OS): Arm VII

    Arm VII: Primary outcome measure

    Through study completion, approximately 2 weeks after last treatment for last patient

Secondary Outcomes (7)

  • Progression Free Survival (PFS): Arms I-VI

    Through study completion, approximately 2 weeks after last treatment for last patient

  • Overall Response Rate (ORR): Arms I-VI

    Through study completion, approximately 2 weeks after last treatment for last patient

  • Overall Survival (OS): Arms I-VI

    Through study completion, approximately 2 weeks after last treatment for last patient

  • Baseline and changes in biomarker levels during treatment

    Arms I-VII; Through study completion, approximately 2 weeks after last treatment

  • Peak Plasma Concentrations (Cmax)

    Arms I-VII; Through study completion, approximately 2 weeks after last treatment

  • +2 more secondary outcomes

Other Outcomes (4)

  • Quality of life evaluation

    Through study completion, approximately 2 weeks after last treatment

  • Changes in dose reductions, treatment discontinuations, and interruptions, and AE's reported related to neuropathy from baseline

    Through study completion, approximately 2 weeks after last treatment

  • Cancer mutational status in blood and tissue biomarker relationship to clinical outcomes

    Arm VII; Through study completion, approximately 2 weeks after last treatment

  • +1 more other outcomes

Study Arms (9)

Part B - Dose Expansion - 1L Gastric Cancer (ARM I)

EXPERIMENTAL

Arm closed to enrollment.

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.

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.

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.

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

Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)

EXPERIMENTAL

Arm closed to enrollment.

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.

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

Drug: BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)

Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB)

ACTIVE COMPARATOR

Arm open to enrollment. 625 mg/m2 BOLD-100 + FOLFOX

Drug: BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)

Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC)

ACTIVE COMPARATOR

Arm open to enrollment. FOLFOX alone.

Drug: BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)

Interventions

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

BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy

Also known as: BOLD-100 +/- Folinic acid (leucovorin), Fluorouracil (5-FU), and Oxaliplatin.
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)
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)DRUG

Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone

Also known as: BOLD-100 +/- Folinic acid (leucovorin), Fluorouracil (5-FU), and Oxaliplatin.
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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. (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.

You may not qualify if:

  • Neuropathy \> grade 2
  • Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin.
  • 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.
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of California, Los Angeles

Santa Monica, California, 90095, United States

COMPLETED

Moffitt Cancer Center

Tampa, Florida, 33612, United States

COMPLETED

Cross Cancer Institue

Edmonton, Alberta, Canada

RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre Glen Site

Montreal, Quebec, Canada

RECRUITING

Universitatsklinikum Bonn

Bonn, Germany

RECRUITING

University Hospital of Ulm

Ulm, Germany

RECRUITING

Mater Miserecordiae University Hospital

Dublin, Ireland

RECRUITING

St. James Hospital

Dublin, Ireland

RECRUITING

St. Vincent's University Hospital

Dublin, Ireland

RECRUITING

National Cancer Center

Goyang, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital - Yonsei University

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsPancreatic NeoplasmsStomach NeoplasmsCholangiocarcinoma

Interventions

LeucovorinFluorouracilOxaliplatinKP 1339

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesStomach DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Central Study Contacts

Michelle Jones

CONTACT

604-262-9899clinical@bold-therapeutics.com

Jim Pankovich

CONTACT

604-262-9934jp@bold-therapeutics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Randomized - Arm VII only: Second line mCRC 500 mg/m2 or 625 mg/m2 in combination with FOLFOX or FOLFOX alone, in a 1:1:1 ratio.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 9, 2020

Study Start

August 28, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)KR(5)IE(3)CA(6)DE(2)