Multiple clinical trials evaluate CBL0137 across diverse oncology indications, including advanced solid tumors, glioblastoma, melanoma, soft tissue sarcoma, and hematological malignancies. Encompassing Early Phase 1, Phase 1, and Phase 1/2 protocols, these studies are sponsored by academic medical centers and industry partners, including Incuron, the Children's Oncology Group, Fox Chase Cancer Center, and Roswell Park Cancer Institute. Recruitment statuses across the portfolio vary, comprising completed, actively recruiting, suspended, and terminated studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05498792 | RECRUITING | Locally Advanced or Metastatic Melanoma |
Fox Chase Cancer Center |
2022-11-30 | EARLY_PHASE1 |
| NCT04870944 | SUSPENDED | Diffuse Midline Glioma, H3 K27-Altered; Metastatic Malignant Neoplasm in the Central Nervous System; Recurrent Diffuse Intrinsic Pontine Glioma; Recurrent Diffuse Midline Glioma, H3 K27-Altered; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Primary Malignant Central Nervous System Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Primary Malignant Central Nervous System Neoplasm |
Children's Oncology Group |
2022-01-28 | PHASE1; PHASE2 |
| NCT03727789 | TERMINATED | Advanced Cutaneous Melanoma of the Extremity; Advanced Sarcoma of the Extremity; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Recurrent Cutaneous Melanoma of the Extremity; Recurrent Sarcoma of the Extremity; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 |
Roswell Park Cancer Institute |
2019-07-01 | PHASE1 |
| NCT05498792 | Suspended | Locally Advanced or Metastatic Melanoma |
Fox Chase Cancer Center|Incuron |
2022-11-30 | Early Phase 1 |
| NCT02931110 | TERMINATED | Hematological Malignancies |
Incuron |
2017-01 | PHASE1 |
| NCT01905228 | COMPLETED | Solid Tumors; Glioblastoma |
Incuron |
2013-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).