A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
ConditionSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZai Lab (Shanghai) Co., Ltd.
About this trial
An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Participant with metastatic or extensive-stage small cell lung cancer (de novo, not transformed) and for Part 1A and 1B must have documented disease progression during or following a platinum-based chemotherapy regimen. For Part 1C and Part 4, no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC). For Part 1B backfill and Part 3, first-line setting: no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC); or, first-line maintenance setting: participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Part 2-1, participants must have received no more than 2 lines of prior therapies in the extensive-stage setting, and progressed on or after a platinum-based chemotherapy regimen AND an anti-DLL3 T-cell engager (TCE). For Part 3, participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator.
Adult men and women ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Participants with another known malignancy that is progressing or requires active treatment within the last 2 years. Exceptions: basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin with previously administered curative treatment, in situ cervical cancer, or other cancers that do not require systemic anti-cancer therapies and will not impact life expectancy.
Subjects with untreated and asymptomatic brain metastases.
Subjects with treated brain metastases that are no longer symptomatic (i.e. without neurologic signs or symptoms), who require no treatment with steriods or anticonvulsants and have recovered from the actue toxic effects of radiotherapy.
Subjects with leptomeningeal disease.
Trial design
Design model
Sequential
Treatments tested in this trial
ZL-1310
DrugDrug: ZL-1310
Atezolizumab
DrugDrug Atezolizumab
Carboplatin
DrugDrug Carboplatin
Treatment groups
339 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Group A: Dose Escalation: Part 1AExperimental treatment 1 intervention
Group B: Dose Expansion: Part 1BExperimental treatment 2 interventions
Group C: Dose Escalation: Part 1CExperimental treatment 3 interventions
Group D: Dose Expansion: Arm 1 (Part 2)Experimental treatment 1 intervention
Group E: Dose Expansion: Arm 2 (Part 2)Experimental treatment 1 intervention
Group F: Dose Extension: Arm 1 (Part 2)Experimental treatment 1 intervention
Group G: Doublet Dose Optimization: Arm 1 (Part 3A)Experimental treatment 2 interventions
Group H: Doublet Dose Optimization: Arm 2 (Part 3A)Experimental treatment 2 interventions
Group I: Triplet Dose Optimization: Arm 1 (Part 4A)Experimental treatment 3 interventions
Group J: Triplet Dose Optimization: Arm 2 (Part 4A)Experimental treatment 3 interventions
Group K: Dose Extension: Part 2-1Experimental treatment 1 intervention
Group L: Doublet Dose Extension: Part 3BExperimental treatment 2 interventions
Group M: Triplet Dose Extension: Part 4BExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)
Number of subjects with Dose Limiting Toxicities (DLTs)
Time frame
up to 24 months2
Incidence of Treatment Emergent Adverse-Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame
up to 24 months3
Incidence of Serious Adverse Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)
Number of subjects with serious adverse events
Time frame
up to 24 months4
Incidence of Treatment Emergent Adverse Events of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3) and in combination with atezolizumab and carboplatin (Part 4)
Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation
Time frame
up to 24 monthsSecondary outcomes
1
Objective response rate (ORR) per RECIST 1.1 of ZL-1310 as a single agent (Part 1A) in combination with atezolizumab (Part 1B), in combination with atezolizumab and carboplatin (Part 1C, Part 3)
Objective Response Rate (ORR) per RECIST 1.1
Time frame
up to 24 months2
Disease control rate (DCR) per RECIST v1.1 of ZL-1310 as a single agent (Part 1A and Part 2), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 4)
Disease control rate (DCR) per RECIST v1.1
Time frame
up to 24 months3
Duration of response per RECIST v1.1
Duration of response per RECIST v1.1
Time frame
up to 24 months4
Progression free survival per RECIST v1.1
Progression free survival per RECIST v1.1
Time frame
up to 24 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