XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXilio Development, Inc.
About this trial
This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX501 as monotherapy in participants with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Measurable disease at baseline per RECIST v1.1
ECOG performance status of 0 or 1
Adequate organ function
Must have histologically confirmed metastatic NSCLC.
Disqualifiers
Prior treatment with IL-2
History of significant pulmonary disease
History of clinically significant cardiovascular disease
Active CNS metastases
Trial design
Design model
Sequential
Treatments tested in this trial
XTX501
DrugXTX501 monotherapy
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Phase 1 - XTX501 Monotherapy Dose Escalation and BackfillExperimental treatment 1 intervention
Group B: Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose Limiting Toxicities (DLTs) in Part 1A
Time frame
Cycle 1 Day 1 up to just prior to the second dose of study drug (approximately 21 days)2
Incidence of treatment-emergent adverse events (Phase 1 and Phase 2)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)3
Incidence of serious adverse events (Phase 1 and Phase 2)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)4
Incidence of significant change from baseline in clinical laboratory values (Phase 1 and Phase 2)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)Secondary outcomes
1
Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 1)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)2
Investigator-assessed duration of response (DOR) per RECIST v1.1 (Phase 1 and Phase 2)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)3
Investigator-assessed disease control rate (DCR) per RECIST v1.1 (Phase 2)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)4
Investigator-assessed progression free survival (PFS) per RECIST v1.1 (Phase 2)
Time frame
Up to Safety Follow Up Period (90 [+7] days after the last dose)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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