BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas

Sponsor
University Health Network, Toronto
Study ID
NCT07027423
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Sarcoma
  • Sarcoma, Soft-tissue
  • Sarcoma,Soft Tissue
  • Sarcomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BOLD-100 — DRUG
    BOLD-100 in combination with Doxorubicin (Escalation)
  • Doxorubicin 75 mg/m^2 — DRUG
    BOLD-100 in combination with Doxorubicin (Escalation)
  • BOLD-100 — DRUG
    BOLD-100 in combination with Doxorubicin (Expansion)
  • Doxorubicin 75 mg/m^2 — DRUG
    BOLD-100 in combination with Doxorubicin (Expansion)

Study Details

A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase. Participants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg/m², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles. Participants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal. Upon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.

Key Dates

First listed
Jun 18, 2025
Start date
Mar 30, 2026
Status verified
Nov 2025
Primary completion
Jan 29, 2027
Completion
Jan 29, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BOLD-100 and Doxorubicin Dose Level -1
    Escalation phase DL-1 - BOLD-100 230mg/m\^2 + Doxorubicin
  • Experimental: BOLD-100 and Doxorubicin Dose Level 1
    Escalation phase DL1 - BOLD-100 420mg/m\^2 + Doxorubicin
  • Experimental: BOLD-100 and Doxorubicin Dose Level 2
    Escalation phase DL2 - BOLD-100 500mg/m\^2 + Doxorubicin
  • Experimental: BOLD-100 and Doxorubicin Dose Level 3
    Escalation phase DL3 - BOLD-100 625mg/m\^2 + Doxorubicin
  • Experimental: BOLD-100 and Doxorubicin
    Exapsnion: BOLD-100 (RP2D) and Doxorubicin

Primary Outcome Measure

The incidence of dose limiting toxicities (DLTs) [ Time Frame: Entire duration of Cycle 1 (21 day cycle) ]

Central Contacts

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