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BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas

NCT07027423 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-01

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

BOLD-100

BOLD-100 in combination with Doxorubicin (Escalation)

DRUG

Doxorubicin 75 mg/m^2

BOLD-100 in combination with Doxorubicin (Escalation)

DRUG

BOLD-100

BOLD-100 in combination with Doxorubicin (Expansion)

DRUG

Doxorubicin 75 mg/m^2

BOLD-100 in combination with Doxorubicin (Expansion)

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2027-01-29
Completion
2027-01-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07027423 on ClinicalTrials.gov