A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.

Sponsor
Hangzhou DAC Biotechnology Co., Ltd.
Study ID
NCT07559929
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • DXC006 — DRUG
    Participants receive DXC006 intravenously on Day 1 every 3 weeks.
  • Toripalimab — DRUG
    Participants receive Toripalimab intravenously on Day 1 every 3 weeks.
  • Carboplatin — DRUG
    Participants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).
  • Cisplatin — DRUG
    Participants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).

Study Details

This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).

Key Dates

First listed
Apr 30, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Dec 30, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DXC006 + ICI
  • Experimental: DXC006 + Platinum(Carboplatin )
  • Experimental: DXC006 + Platinum(Cisplatin )

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year. ]

Central Contacts

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