Clinical Trials

A clinical trial sponsored by Nimbus Saturn, Inc. is evaluating NDI-101150 in an open-label Phase 1/2 investigation to assess its safety, tolerability, pharmacokinetics, and preliminary therapeutic activity. The study targets patients presenting with advanced solid tumors, renal cell carcinoma, gastric and gastroesophageal junction adenocarcinoma, and non-small cell lung cancer. Currently, the recruitment status for this ongoing trial is active, not recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05128487 ACTIVE_NOT_RECRUITING
Solid Tumor; Renal Cell Carcinoma (Kidney Cancer); Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma; Non-Small Cell Lung Cancer
Nimbus Saturn, Inc.
 2021-11-05 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2024-11-25)

Check the NDI-101150 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NDI-101150 acts as a potent inhibitor of hematopoietic progenitor kinase 1 (HPK1, also designated MAP4K1), blocking downstream negative regulatory signaling pathways in immune cells to enhance the activation and function of T cells, B cells, and dendritic cells. By reversing immune suppression and driving anti-tumor immune activity, this targeted kinase inhibition demonstrates clinical relevance in restricting tumor growth across conditions such as renal cell carcinoma, gastric and gastroesophageal junction adenocarcinoma, non-small cell lung cancer, and other advanced solid tumors.

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>).

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Note: Technical data last updated: Sep 1, 2026.