Another Clinical Trail to Treat Metastatic Sarcoma
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
https://clinicaltrials.gov/ct2/show/NCT03715933?term=DR5+INBRX109&rank=1
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| Arm | Intervention/treatment |
|---|---|
| Experimental: Dose Escalation INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas. | Drug: INBRX-109 – multivalent DR5 agonist antibody The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5). |
| Experimental: Expansion Malignant Pleural Mesothelioma Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D. | Drug: INBRX-109 – multivalent DR5 agonist antibody The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5). |
| Experimental: Expansion Gastric Adenocarcinoma Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D. | Drug: INBRX-109 – multivalent DR5 agonist antibody The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5). |
| Experimental: Expansion Colorectal Adenocarcinoma Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D. | Drug: INBRX-109 – multivalent DR5 agonist antibody The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5). |
Outcome Measures
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Primary Outcome Measures :
- Frequency and severity of adverse events of INBRX-109 [ Time Frame: Up
to 2 years ] Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. - Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109 [ Time Frame: Up to
2 years ] The MTD and/or RP2D of INBRX-109 will be determined.
Secondary Outcome Measures :
- Area under the serum concentration time curve (AUC) of INBRX-109 [ Time Frame: Up to
2 years ] Area under the serum concentration time curve (AUC) of INBRX-109 will be determined. - Immunogenicity of INBRX-109 [ Time Frame: Up to
2 years ] Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined. - Maximum observed serum concentration (Cmax) of INBRX-109 [ Time Frame: Up
to 2 years ] Maximum observed serum concentration (Cmax) of INBRX-109 will be determined. - Trough observed serum concentration (Ctrough) of INBRX-109 [ Time Frame: Up to
2 years ] Trough observed serum concentration (Cmax) of INBRX-109 will be determined. - Time to Cmax (Tmax) of INBRX-109 [ Time Frame: Up to
2 years ] Time to Cmax (Tmax) of INBRX-109 will be determined.
Other Outcome Measures:
- Anti-tumor activity of INBRX-109 [ Time Frame: Up to
2 years ] Tumor response will be determined by RECISTv1.1.