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Also known as CG009301 for Injection
CG009301 · 1 trial · 5 indications
RDE refer to recommended dose for expansion
| Arm | Type | Description |
|---|---|---|
| 0.25mg QD | EXPERIMENTAL | CG009301 for Injection |
| 0.5mg QD | EXPERIMENTAL | CG009301 for Injection |
| 1.0mg QD | EXPERIMENTAL | CG009301 for Injection |
| 1.6mg QD | EXPERIMENTAL | CG009301 for Injection |
| 2.5mg QD | EXPERIMENTAL | CG009301 for Injection |
| 3.5mg QD | EXPERIMENTAL | CG009301 for Injection |
| 5.0mg QD | EXPERIMENTAL | CG009301 for Injection |
| 6.5mg QD | EXPERIMENTAL | CG009301 for Injection |
| 8.25mg QD | EXPERIMENTAL | CG009301 for Injection |
| 10.0mg QD | EXPERIMENTAL | CG009301 for Injection |
| Name | Type | Description |
|---|---|---|
| CG009301 for Injection | DRUG | 0.9% Sodium Chloride Injection diluted to 250mL，Cycle 1 and subsequent cycles, IV, infusion duration: 2 hours, once daily (QD) administration for 7 days continuously(28 days constituting one cycle) |
Inclusion Criteria: 1. Age ≥18 years and \<75 years at the time of signing the informed consent form; no gender restrictions; 2. Patients with relapsed/refractory haematological malignancies who have received a definitive diagnosis by pathology and/or cytology, confirmed histologically, and who hav...
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CG009301 is an investigational small molecule being developed for the treatment of leukemia and other haematological malignancies. It is currently being studied in adult subjects with recurrent or refractory haematological malignancies, including acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
CG009301 targets GSPT1, a protein involved in cellular processes relevant to cancer. By targeting GSPT1, the drug aims to interfere with the growth of malignant cells. This mechanism is being evaluated in a Phase 1 clinical trial for the treatment of haematological cancers.
CG009301 is being developed by Pulmatrix, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PULM. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of CG009301 in patients with recurrent or refractory haematological malignancies.
CG009301 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of CG009301 in adult patients with certain blood cancers.
CG009301 is being studied in a single Phase 1 clinical trial with the identifier NCT07347171. This trial is titled 'A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies' and is currently recruiting participants in China. The study plans to enroll 45 patients.
Yes, CG009301 for Injection is the same drug as CG009301. The name 'CG009301 for Injection' refers to the formulation of the drug that is administered via injection. Both names refer to the same investigational small molecule being developed by Pulmatrix, Inc. for the treatment of haematological malignancies.