Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLN-081 · 1 trial · 2 indications
Maximum Plasma Concentration \[Cmax\]
| Arm | Type | Description |
|---|---|---|
| Phase 1 Dose Escalation (Accelerated Titration) | EXPERIMENTAL | CLN-081 BID in single patient dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations that either have received or never received prior EGFR TKIs. |
| Phase 1 Dose Escalation (Rolling Six) | EXPERIMENTAL | CLN-081 BID in Rolling Six dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations. |
| Phase 2a Dose Expansion(s) | EXPERIMENTAL | CLN-081 BID in expansion cohorts that may be opened at doses that meet pre-specified efficacy and safety criteria. |
| Module A Food Affect | EXPERIMENTAL | Single-dose CLN-081 150 mg with and without high fat food intake. |
| Module B | EXPERIMENTAL | CLN-081 BID in NSCLC patients with EGFR exon 20 insertion mutations that have received prior systemic therapy for locally advanced or metastatic disease. |
| Module C | EXPERIMENTAL | CLN-081 BID to patients with EGFR exon 20 insertion mutant NSCLC after prior therapy with an agent approved for the treatment of ex20ins mutant NSCLC. |
| Name | Type | Description |
|---|---|---|
| CLN-081 | DRUG | CLN-081 tablets |
Inclusion Criteria 1. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (all patients). 2. Documented EGFR ex20ins mutation demonstrated by a validated test listed in Section 9.7 and performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalen...
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CLN-081 is an investigational small molecule being developed for the treatment of non-small cell lung cancer (NSCLC), specifically in patients with EGFR exon 20 mutations. It is currently in Phase 1 clinical development and has not been approved by the FDA.
CLN-081 targets the epidermal growth factor receptor (EGFR), a protein involved in cell growth and division. By targeting EGFR, CLN-081 is designed to address cancers driven by mutations in this receptor, such as EGFR exon 20 mutations found in non-small cell lung cancer.
CLN-081 is being developed by Cullinan Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CGEM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with non-small cell lung cancer.
CLN-081 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness in patients with non-small cell lung cancer.
CLN-081 is being studied in a Phase 1/2 trial with the identifier NCT04036682. This trial is active but not recruiting participants and has an enrollment of 284 patients. The study is evaluating CLN-081 in patients with non-small cell lung cancer and EGFR exon 20 mutations across multiple countries.
CLN-081 is a distinct investigational small molecule targeting EGFR, specifically designed for non-small cell lung cancer with EGFR exon 20 mutations. While it shares a target with other EGFR inhibitors, it is a unique compound being developed by Cullinan Therapeutics and is not the same as other approved or investigational EGFR-targeting drugs.