Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04036682 | A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 284 | — | — | Oct 31, 2019 | Mar 31, 2026 | Mar 13, 2025 | 64 | United States, Hong Kong +7 |
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...