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BXQ-350 · 1 trial · 2 indications
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....
BXQ-350 is an investigational small molecule being studied for the treatment of metastatic colorectal carcinoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in a clinical trial for patients with this condition.
BXQ-350 is being developed by Icon Plc, a company traded on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical research on this investigational drug for metastatic colorectal carcinoma.
BXQ-350 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is currently being studied in an active clinical trial for metastatic colorectal carcinoma.
BXQ-350 is being studied in a Phase 1 clinical trial with the identifier NCT05322590, titled "BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma." The trial is active but not recruiting, with an enrollment of 195 participants in the United States.
Yes, the clinical trial for BXQ-350 is randomized, double-blind, and placebo-controlled. This means participants are randomly assigned to receive either BXQ-350 or a placebo, and neither the participants nor the researchers know who receives which treatment during the study.