Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies
NotableReclassified as terminated (was completed)Sponsor's reason: The combination therapy arm of the study with pembrolizumab did not yield an efficacy signal, so enrollment into the combination therapy arm was terminated. The monotherapy arm of the study was fully enrolled and completed.
Results posted: Oct 9, 2026
NotableTrial status: Completed to TerminatedShow 7 more changesShow less
Results first posted: Oct 9, 2026
Primary endpoint revised
Sponsor's reason: The combination therapy arm of the study with pembrolizumab did not yield an efficacy signal, so enrollment into the combination therapy…
Eligibility criteria expanded, about 22 words
Secondary endpoints revised (8)
Collaborators: details revised at 1 of 2 entries
Publications: details revised at 1 of 1 entry
NotablePrimary endpoints: 2 to 1v18
MinorTrial status: Active, Not Recruiting to Completed
Primary and study completion dates changed from estimate of Apr 2025 to May 21, 2025
v17
MinorPrimary completion date: Feb 2025 to Apr 2025v16
Show 14 earlier versionsHide 14 earlier versions
MinorTrial status: Recruiting to Active, Not Recruiting
MinorInterventions: CTX-471 (Drug), pembrolizumab (Drug) to CTX-471 (Drug), Pembrolizumab (Drug)v13
MinorEligibility criteria expanded, about 68 wordsv12
NotableEnrollment target: 96 to 157v11Show 10 more changesShow less
Primary completion date: Jul 2022 to Feb 2025
Primary endpoints revised (2)
Study completion date: Sep 2022 to Apr 2025
Interventions: CTX-471 (Drug) to CTX-471 (Drug), pembrolizumab (Drug)
Eligibility criteria expanded, about 771 words
Secondary endpoints revised (8)
Site details revised at 2 of 10 sites
Collaborators: 1 to 2
Study title expanded, about 8 words
Study arms: 2 to 4
MinorStudy sites: 8 to 10
Eligibility criteria expanded, about 16 words
v10
NotablePrimary completion date: Mar 2021 to Jul 2022
Study completion date: Jul 2021 to Sep 2022
v9
MinorEnrollment target: 81 to 96
Eligibility criteria revised
v8
MinorSite details revised at 1 of 8 sitesv7
MinorEligibility criteria shortened, about 5 wordsv6
MinorStudy sites: 7 to 8v5
MinorStudy sites: 5 to 7v4
MinorSite details revised at 2 of 5 sitesv3
NotableTrial status: Not Yet Recruiting to Recruitingv2Show 4 more changesShow less
Study sites: 0 to 5
Start date changed from estimate of Apr 2019 to May 17, 2019
Eligibility criteria shortened, about 10 words
Study title shortened, about 4 words
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In each arm (monotherapy and combination therapy), data from Part 1 (dose escalation) and Part 2 (dose expansion) were combined by dose level for reporting.