BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas

Phase 1

Not yet recruiting

• Conditions: Sarcoma; Sarcoma, Soft-tissue; Sarcoma,Soft Tissue; Sarcomas
• Interventions: Drug: BOLD-100; Drug: Doxorubicin 75 mg/m^2

• Registration Number: NCT07027423
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2025-06-30
• Primary Completion: 2027-01-29
• Study Completion: 2027-01-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BOLD-100 and Doxorubicin Dose Level -1	BOLD-100	Escalation phase DL-1 - BOLD-100 230mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level -1	Doxorubicin 75 mg/m^2	Escalation phase DL-1 - BOLD-100 230mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level 1	BOLD-100	Escalation phase DL1 - BOLD-100 420mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level 1	Doxorubicin 75 mg/m^2	Escalation phase DL1 - BOLD-100 420mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level 2	BOLD-100	Escalation phase DL2 - BOLD-100 500mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level 2	Doxorubicin 75 mg/m^2	Escalation phase DL2 - BOLD-100 500mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level 3	BOLD-100	Escalation phase DL3 - BOLD-100 625mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin Dose Level 3	Doxorubicin 75 mg/m^2	Escalation phase DL3 - BOLD-100 625mg/m\^2 + Doxorubicin
BOLD-100 and Doxorubicin	BOLD-100	Exapsnion: BOLD-100 (RP2D) and Doxorubicin
BOLD-100 and Doxorubicin	Doxorubicin 75 mg/m^2	Exapsnion: BOLD-100 (RP2D) and Doxorubicin

Primary Outcome Measures

Name	Time	Method
The incidence of dose limiting toxicities (DLTs)	Entire duration of Cycle 1 (21 day cycle)
The rate of Adverse Events (AE)	time the consent form is signed through 12 months following cessation of treatment	The rate of Adverse Events (AE) characterized by type, frequency, severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Rate of toxicities	time the consent form is signed through 12 months following cessation of treatment.	Rate of toxicities as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, adverse events (AEs), serious AEs (SAEs), dose interruptions and assessment.
Participant Quality of Life	pre-dose, Cycle 2 Day1, Cycle 7 Day 1, Cycle 12 Day 1 (21 day cycles)	Assessed using EORTC QLQ-C30 (European Organization For Research And Treatment Of Cancer, Core Quality of Life Questionnaire). With scores from 0 to 100. A high scale score represents a higher response level.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	time the consent form is signed through treatment completion, up to 4-6 weeks after progression if applicable	Progression-free survival (PFS), response rate using RECIST v 1.1, clinical benefit rate (CR, PR, SD \>16 weeks) using the Kaplan Meier method to estimate with corresponding 95% CI
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100	During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)	Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100 (in the first 3 patients per dose level) using time to peak drug concentration (Tmax), which will be compared to single agent population PK of doxorubicin and BOLD-100.

Trial Locations

Locations (1)

UHN- Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada