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NCT04421820

BOLD-100 in Combination With FOLFOX With or Without Bevacizumab for the Treatment of Advanced, Solid Tumours

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved 1 year 1 month later.

See at-risk trials from Bold Therapeutics, Inc.

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Record History

All 21 versions: 19 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 1, 2026 to Jul 1, 2027 Show 7 more changesShow less
    • Trial sites expanded: 24 → 28 locations
    • Study completion pushed from Sep 1, 2026 to Dec 31, 2027
    • Interventions modified
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description expanded, about 24 words
    • Study title expanded, about 4 words
  2. Trial sites expanded: 18 → 24 locationsv20
  3. Study sites: 16 to 18v19
  4. Primary endpoints: 4 to 6v18 Show 6 more changesShow less
    • Study sites: 14 to 16
    • Interventions: BOLD-100 in combination with FOLFOX Chemotherapy (Dose Escalation) (Drug), BOLD-100 in combination with FOLFOX Chemotherapy (Dose… to BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) (Drug), BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) (Drug)
    • Eligibility criteria shortened, about 633 words
    • Secondary endpoints: 8 to 7
    • Study description expanded, about 182 words
    • Study arms: 11 to 9
  5. Site details revised at 2 of 14 sitesv17
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 1 of 14 sitesv16
  2. Study sites: 13 to 14v15
  3. Trial status: Active, Not Recruiting to Recruitingv14 Show 6 more changesShow less
    • Enrollment target: 117 to 220
    • Primary completion date: Dec 31, 2023 to Jun 1, 2026
    • Study completion date: Sep 30, 2024 to Sep 1, 2026
    • Eligibility criteria expanded, about 87 words
    • Site details revised at 13 of 13 sites
    • Study arms: 10 to 11
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 117
    • Site details revised at 13 of 13 sites
    v13
  5. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Dec 31, 2023 to Sep 30, 2024
    v11
  6. Phase: Phase 1 to Phase 1/2v10 Show 5 more changesShow less
    • Enrollment target: 80 to 100
    • Study completion date: Jan 1, 2023 to Dec 31, 2023
    • Interventions: BOLD-100 in combination with FOLFOX Chemotherapy (Drug) to BOLD-100 in combination with FOLFOX Chemotherapy (Dose Escalation) (Drug), BOLD-100 in combination with FOLFOX Chemotherapy (Dose…
    • Eligibility criteria expanded, about 117 words
    • Study arms: 4 to 10
  7. Study sites: 6 to 13v9
  8. Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Study completion date: Mar 31, 2022 to Jan 1, 2023
    v8
  9. Site details revised at 2 of 6 sitesv7
  10. Study sites: 5 to 6v6
  11. Site details revised at 1 of 5 sitesv5
  12. Study sites: 3 to 5v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    • Start date changed from estimate of Aug 15, 2020 to Aug 28, 2020
    • Study title revised
    v3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence and severity of adverse events ([S]AEs)
Timeframe: Through study completion, approximately 2 weeks after last treatment
Incidence of dose-limiting toxicities (DLT)
Timeframe: 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
Timeframe: Through study completion, approximately 2 weeks after last treatment
Progression Free Survival (PFS): Arm VII
Timeframe: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Response Rate (ORR): Arm VII
Timeframe: Through study completion, approximately 2 weeks after last treatment for last patient
Overall Survival (OS): Arm VII
Timeframe: Through study completion, approximately 2 weeks after last treatment for last patient

Secondary (7)

Progression Free Survival (PFS): Arms I-VI
Overall Response Rate (ORR): Arms I-VI
Overall Survival (OS): Arms I-VI
Baseline and changes in biomarker levels during treatment
Peak Plasma Concentrations (Cmax)
Show 2 moreShow less
Area under the plasma concentration versus time (AUC)
Elimination half life (T1/2)

Arms and interventions

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

Arm closed to enrollment.

Part B - Dose Expansion - 2L Gastric Cancer (ARM II)Experimental

Arm closed to enrollment.

Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)Experimental

Arm closed to enrollment.

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

Arm closed to enrollment.

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

Arm closed to enrollment.

Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)Experimental

Arm closed to enrollment.

Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA)Active comparator

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

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

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

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

Arm open to enrollment. FOLFOX ± Bevacizumab alone.

Drugs: BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII), BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

Sites

28 sites in 8 countries

Canada 6, South Korea 5, United Kingdom 4, Ireland 3, Italy 3, Spain 3, Germany 2, United States 2