A Study of ZL-1310 in Subjects With Small Cell Lung Cancer

Conditions

• SCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ZL-1310 — DRUG
  Drug: ZL-1310
• Atezolizumab — DRUG
  Drug Atezolizumab
• Carboplatin — DRUG
  Drug Carboplatin

Study Details

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

Key Dates

Start date

Jan 23, 2024

Status verified

Mar 2026

Primary completion

May 30, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

339 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation: Part 1A
  ZL-1310 as a single-agent
• Experimental: Dose Expansion: Part 1B
  ZL-1310 in combination with Atezolizumab
• Experimental: Dose Escalation: Part 1C
  ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance
• Experimental: Dose Expansion: Arm 1 (Part 2)
  Dose level 1 of ZL-1310 established from single-agent dose-escalation
• Experimental: Dose Expansion: Arm 2 (Part 2)
  Dose level 2 of ZL-1310 established from single-agent dose escalation
• Experimental: Dose Extension: Arm 1 (Part 2)
  ZL-1310 as a single agent
• Experimental: Doublet Dose Optimization: Arm 1 (Part 3A)
  Dose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab
• Experimental: Doublet Dose Optimization: Arm 2 (Part 3A)
  Dose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab
• Experimental: Triplet Dose Optimization: Arm 1 (Part 4A)
  Dose level 1 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + Atezolizumab as maintenance
• Experimental: Triplet Dose Optimization: Arm 2 (Part 4A)
  Dose level 2 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + atezolizumab as induction
• Experimental: Dose Extension: Part 2-1
  single-agent dose extension for Post-anti-DLL3
• Experimental: Doublet Dose Extension: Part 3B
  Doublet dose extension for 1L maintenance only OR 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.
• Experimental: Triplet Dose Extension: Part 4B
  Triplet dose extension for 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.

Primary Outcome Measure

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) [ Time Frame: up to 24 months ]

Central Contacts

• Erin Nurre
  8596094423
  [email protected]
• Mona Qureshi
  [email protected]

Locations (11)

Find similar trials in Duarte, CA

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