A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
← catalyst calendarSponsored by Cullinan Therapeutics Inc. (industry) · CGEM — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
440estimated
Sites
24
Countries
Australia, Poland, Spain +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-10-29 | actual | When the study began enrolling |
| Primary completion | Mar 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumor
- NSCLC
Interventions
- Drug: CLN-619
- Drug: Pembrolizumab
- Drug: Paclitaxel
- Drug: Carboplatin AUC 6
- Drug: pemetrexed
- Drug: Datopotamab deruxtecan-dlnk (Dato-DXd)
Primary outcomes
what the primary-completion date above is the date OFDose Escalation: TEAEs
measured 24 Months
Dose Expansion: Best Overall Response (BOR)
measured Every 6 weeks for the first 18 weeks and then every 9 weeks until disease progression; approximately 36 months
Dose Expansion: Overall Response Rate (ORR)
measured Every 6 weeks for the first 18 weeks and then every 9 weeks until disease progression; approximately 36 months
Dose Expansion: Duration of Response (DoR)
measured Every 6 weeks for the first 18 weeks and then every 9 weeks until disease progression; approximately 36 months
Dose Expansion: Disease Control Rate (DCR)
measured Every 6 weeks for the first 18 weeks and then every 9 weeks until disease progression; approximately 36 months
Dose Expansion: Overall Survival (OS)
measured Every 6 weeks for the first 18 weeks and then every 9 weeks until disease progression; approximately 36 months
Dose Expansion: Clinical Benefit Rate (CBR)
measured Every 6 weeks for the first 18 weeks and then every 9 weeks until disease progression; approximately 36 months
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