Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05322590 | BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma | PHASE1 | ACTIVE NOT_RECRUITING | 195 | — | — | Jan 9, 2023 | Apr 1, 2029 | Dec 20, 2024 | 12 | United States |
To determine the recommended phase 2 dose of BXQ-350, when given with mFOLFOX7 and bevacizumab, according to the investigational product (IP) related dose limiting toxicities (DLTs).
To determine the safety of BXQ-350 when given with mFOLFOX7 and bevacizumab, as evidenced by the incidence of treatment emergent adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
To determine the ORR of BXQ-350 when given with mFOLFOX7 and bevacizumab. ORR is defined as the percentage of participants with evidence of a complete or partial response as per the Response Evaluation Criteria in Solid Tumors (RECIST).
| Arm | Type | Description |
|---|---|---|
| BXQ-350 | EXPERIMENTAL | BXQ-350 will be administered by IV infusion |
| Placebo | PLACEBO_COMPARATOR | Placebo (0.9% normal saline) will be administered by IV infusion (Stage 2 only) |
| Name | Type | Description |
|---|---|---|
| BXQ-350 | DRUG | BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 will be administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible. |
| Placebo | OTHER | Placebo will be 0.9% normal saline of matching volume to BXQ-350 administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible (Stage 2 only) |
Inclusion Criteria: Participants who meet the following criteria will be considered eligible to participate in the clinical study: 1. Age ≥ 18 years of age at the time of signing the informed consent. 2. Participants have newly diagnosed Stage IV metastatic adenocarcinoma of the colon / rectum. 3....