BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBold Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
DrugArm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
DrugBOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
Treatment groups
220 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)Experimental treatment 1 intervention
Group B: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)Experimental treatment 1 intervention
Group C: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)Experimental treatment 1 intervention
Group D: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)Experimental treatment 1 intervention
Group E: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)Experimental treatment 1 intervention
Group F: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)Experimental treatment 1 intervention
Group G: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA)Active comparator 1 intervention
Group H: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB)Active comparator 1 intervention
Group I: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events ([S]AEs)
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Time frame
Through study completion, approximately 2 weeks after last treatment2
Incidence of dose-limiting toxicities (DLT)
Dose escalation only.
Time frame
Screening to 4 weeks after first treatment3
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
Time frame
Through study completion, approximately 2 weeks after last treatment4
Progression Free Survival (PFS): Arm VII
Arm VII: Primary outcome measure
Time frame
Through study completion, approximately 2 weeks after last treatment for last patientSecondary outcomes
1
Progression Free Survival (PFS): Arms I-VI
Arms I-VI: Secondary outcome measure
Time frame
Through study completion, approximately 2 weeks after last treatment for last patient2
Overall Response Rate (ORR): Arms I-VI
Arms I-VI: Secondary outcome measure
Time frame
Through study completion, approximately 2 weeks after last treatment for last patient3
Overall Survival (OS): Arms I-VI
Arms I-VI: Secondary outcome measure
Time frame
Through study completion, approximately 2 weeks after last treatment for last patient4
Baseline and changes in biomarker levels during treatment
Serum GRP78
Time frame
Arms I-VII; Through study completion, approximately 2 weeks after last treatmentOther outcomes
1
Quality of life evaluation
Arm VII
Time frame
Through study completion, approximately 2 weeks after last treatment2
Changes in dose reductions, treatment discontinuations, and interruptions, and AE's reported related to neuropathy from baseline
Arm VII
Time frame
Through study completion, approximately 2 weeks after last treatment3
Cancer mutational status in blood and tissue biomarker relationship to clinical outcomes
Circulatory tumor DNA (ctDNA) collection will be tested for a panel of tumor mutations, genomic alterations, microsatellite instability and tumor mutational burden, and these will be associated to clinical outcomes, including overall survival, progression-free survival, overall response rate and other outcome measures
Time frame
Arm VII; Through study completion, approximately 2 weeks after last treatment4
GRP78 levels and relationship to clinical outcomes
Optional biopsy samples at screening and at cycle 4 will be collected and analyzed for GRP78 levels, other related pathway markers, immune cell profiles, and cancer mutation profiles, and comparing these to clinical outcomes including overall survival, progression-free survival, overall response rate and other outcome measures
Time frame
Arm VII; Through study completion, approximately 2 weeks after last treatmentSponsors and contacts
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Source ClinicalTrials.gov