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 oral therapy being studied for non-small cell lung cancer, specifically in patients whose tumors carry EGFR exon 20 insertion mutations. It is a biomarker-selected treatment, meaning trial enrollment is limited to patients whose cancers test positive for that mutation. It is not approved for any use and remains in clinical development.
CLN-081 targets EGFR, the epidermal growth factor receptor, and acts as an inhibitor of that target. It is a small molecule designed to inhibit EGFR signaling in tumors driven by EGFR mutations, including exon 20 insertion variants. Targeting EGFR is the basis for its study in EGFR-mutant non-small cell lung cancer.
CLN-081 is being developed by Cullinan Therapeutics, Inc., which trades on the Nasdaq under the ticker CGEM. The company is the sponsor of the clinical program evaluating the drug in EGFR-mutant non-small cell lung cancer.
CLN-081 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing study is a Phase 1/2 trial, and the program remains in early-stage clinical testing in non-small cell lung cancer.
CLN-081 is being evaluated in the Phase 1/2 trial NCT04036682, titled A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer. The trial has enrolled 284 patients, is active but not recruiting, and is conducted across the United States, Hong Kong, Italy, Japan, the Netherlands, Singapore, South Korea, Spain, and Taiwan.
CLN-081 is being studied in non-small cell lung cancer, the most common form of lung cancer. The trial enrolls patients with EGFR exon 20 insertion mutations, a specific molecular subgroup of the disease. It is an investigational small molecule and is not approved to treat any cancer.