A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer

Sponsor
SUNHO（China）BioPharmaceutical CO., Ltd.
Study ID
NCT07076095
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • IBB0979 — DRUG
    bifunctional antibody-cytokine fusion protein that targets B7-H3 and IL-10 receptor
  • topotecan hydrochloride for injection — DRUG
    Topotecan hydrochloride will be administered intravenously per prescribing information.

Study Details

This study was designed to compare the efficacy and safety of IBB0979 in combination with topotecan versus topotecan in subjects with relapsed small cell lung cancer (SCLC).

Key Dates

First listed
Jul 21, 2025
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Aug 1, 2028
Completion
Aug 1, 2031

Study Design

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

Arms

  • Experimental: Part 1(Phase IIa)
    To evaluate the safety and efficacy of IBB0979 in patients with SCLC. Cohort 1: IBB0979 iv Q3W; Cohort 2: IBB0979 iv Q2W.
  • Experimental: Part 2(Phase IIb)
    To evaluate the safety and efficacy of IBB0979 in combination with topotecan in patients with SCLC.

Primary Outcome Measure

Frequency of adverse events (AEs) and SAEs (Phase II) [ Time Frame: Approximately within 36 months ]

Central Contacts

Find similar trials

Nationwide
Lung cancer trialsOncology trialsLung oncology trialsLung disease trials

Related Studies