A Study of ZL-1310 in Participants With Selected Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZai Lab (Shanghai) Co., Ltd.
About this trial
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Adult men and women ≥18 years of age
Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC)
Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
Disqualifiers
Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
Clinically active central nervous system (CNS) metastases
Participants with leptomeningeal metastasis
Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from.
Trial design
Design model
Single group
Treatments tested in this trial
ZL-1310
Drugdrug ZL-1310
Treatment groups
166 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment Emergent Adverse-Events in Phase 1b
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame
up to 36 months2
Incidence of Serious Adverse Events in Phase 1b
Number of subjects with serious adverse events (SAEs)
Time frame
up to 36 months3
Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2
Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2
Time frame
up to 36 monthsSecondary outcomes
1
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b
1. BICR-determined confirmed ORR in all cohorts 2. Investigator-determined confirmed ORR in all cohorts 3. BICR-determined 6-months progression-free survival (PFS6) rate in Cohort 3 4. Investigator-determined PFS6-rate in Cohort 3
Time frame
up to 36 months2
Evaluate durability of response in Phase 1b
1\. BICR- and investigator-determined duration of response (DOR) in Phase 1b
Time frame
up to 36 months3
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2
Investigator-determined confirmed ORR in Phase 2
Time frame
up to 36 months4
Evaluate durability of response in Phase 2
1\. BICR- and investigator-determined duration of DOR in Phase 2
Time frame
up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zai Lab (Shanghai) Co., Ltd.
Lead sponsor
Zai Lab (US) LLC
Collaborator
Source ClinicalTrials.gov