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Small Cell Lung CancerPhase 2NCT07076095

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

A Phase 2 study testing IBB0979 and topotecan hydrochloride for injection in people with Small Cell Lung Cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
IBB0979 and topotecan hydrochloride for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 Aug 2025to 1 Aug 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 and ≤75 years, male or female.
  • Histologically confirmed SCLC.
  • Relapsed small cell lung cancer (limited-stage, extensive-stage) that has failed or progressed after first-line or second-line systemic therapy.
  • At least one measurable lesion according to RECIST version 1.1.
  • ECOG PS 0 or 1.
  • Life expectancy ≥ 3 months.
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  • Adequate organ function.
  • Men or women should be using adequate contraceptive measures throughout the study. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Who cannot join

  • Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
  • Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
  • History of anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration.
  • History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
  • History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.
  • History of systemic corticosteroid therapy with exceptions defined in the protocol.
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  • Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.
  • Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
  • History of prior allogeneic stem-cell or solid organ transplantation.
  • Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
  • Untreated brain metastases with exceptions defined in the protocol.
  • Evidence of active infection requiring intravenous anti-infective therapy.
  • Have a history of immune deficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
  • Active hepatitis B, active hepatitis C.
  • Currently has interstitial lung disease (with exception of radiation pulmonary fibrosis that requires no hormone therapy).
  • History of severe cardiovascular and cerebrovascular diseases.
  • Active or suspected autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with exceptions defined in the protocol.
  • History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2 immune-associated myocarditis accompanied with immunotherapy with exceptions defined in the protocol.
  • History of other malignancy with exceptions defined in the protocol.
  • Pleural effusion/peritoneal effusion/Pericardial effusion requiring clinical intervention.
  • Known alcohol or drug dependence.
  • History of mental disorder or poor adherence.
  • The female patient who is pregnant or breastfeeding.
  • History of other severe systemic disease, or any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

ya ze jiao contact

15950520087

15950520087@163.com

About this study

Official title: A Phase II/III Study to Compare IBB0979 in Combination With Topotecan Versus Topotecan in Subjects With Relapsed Small Cell Lung Cancer

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).

Being tested
IBB0979, topotecan hydrochloride for injection
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBB0979Drug

    bifunctional antibody-cytokine fusion protein that targets B7-H3 and IL-10 receptor

  • topotecan hydrochloride for injectionDrug

    Topotecan hydrochloride will be administered intravenously per prescribing information.

Study groups in NCT07076095
Study groupRoleWhat they receive
Part 1(Phase IIa)ExperimentalTo evaluate the safety and efficacy of IBB0979 in patients with SCLC. Cohort 1: IBB0979 iv Q3W; Cohort 2: IBB0979 iv Q2W.
Receives: Drug: IBB0979
Part 2(Phase IIb)ExperimentalTo evaluate the safety and efficacy of IBB0979 in combination with topotecan in patients with SCLC.
Receives: Drug: IBB0979; Drug: topotecan hydrochloride for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events (AEs) and SAEs (Phase II)

    To investigate the safety characteristics.

    Measured: Approximately within 36 months

Secondary outcomes (22)

  1. Pharmacokinetic (PK) Cmax (Phase II)

    PK parameters (Cmax) following single dose.

    Measured: Approximately within 36 months

  2. Pharmacokinetic (PK) Cmin (Phase II)

    PK parameters (Cmin) following single dose.

    Measured: Approximately within 36 months

  3. Pharmacokinetic (PK) Tmax (Phase II)

    PK parameters (Tmax) following single dose.

    Measured: Approximately within 36 months

  4. Pharmacokinetic (PK) AUC 0-t (Phase II)

    PK parameters (AUC 0-t) following single dose.

    Measured: Approximately within 36 months

  5. Pharmacokinetic (PK) AUC 0-∞ (Phase II)

    PK parameters (AUC 0-∞) following single dose.

    Measured: Approximately within 36 months

  6. Pharmacokinetic (PK) CL (Phase II)

    PK parameters (CL) following single dose.

    Measured: Approximately within 36 months

  7. Pharmacokinetic (PK) Vd (Phase II)

    PK parameters (Vd) following single dose.

    Measured: Approximately within 36 months

  8. Pharmacokinetic (PK) t1/2 (Phase II)

    PK parameters (t1/2) following single dose.

    Measured: Approximately within 36 months

  9. Pharmacokinetic (PK) λz (Phase II)

    PK parameters (λz) following single dose.

    Measured: Approximately within 36 months

  10. Pharmacokinetic (PK) Css,max (Phase II)

    PK parameters (Css,max) following multiple dose.

    Measured: Approximately within 36 months

  11. Pharmacokinetic (PK) Css,min (Phase II)

    PK parameters (Css,min) following multiple dose.

    Measured: Approximately within 36 months

  12. Pharmacokinetic (PK) Css,av (Phase II)

    PK parameters (Css,av) following multiple dose.

    Measured: Approximately within 36 months

  13. Pharmacokinetic (PK) AUCss (Phase II)

    PK parameters (AUCss) following multiple dose.

    Measured: Approximately within 36 months

  14. Pharmacokinetic (PK) CLss (Phase II)

    PK parameters (CLss) following multiple dose.

    Measured: Approximately within 36 months

  15. Pharmacokinetic (PK) Vss (Phase II)

    PK parameters (Vss) following multiple dose.

    Measured: Approximately within 36 months

  16. Pharmacokinetic (PK) R (Phase II)

    PK parameters (R) following multiple dose.

    Measured: Approximately within 36 months

  17. Pharmacokinetic (PK) DF (Phase II)

    PK parameters (DF) following multiple dose.

    Measured: Approximately within 36 months

  18. Incidence of Anti-Drug Antibodies (ADA)(Phase II)

    Measured: Approximately within 36 months

  19. Overall survival (OS) (Phase II)

    OS as assessed using RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

  20. Objective response rate (ORR)(Phase II)

    Tumor response based on RECIST 1.1.

    Measured: Baseline through up to 1 years or until disease progression

  21. Progression free survival (PFS) (Phase II)

    PFS as assessed using RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

  22. Disease control rate (DCR) (Phase II)

    DCR as assessed using RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076095
Sponsor's protocol ID
IBB0979-201
Status last verified
Jul 2025
First submitted
17 Jul 2025
Last updated
21 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBB0979 and topotecan hydrochloride for injection in people with Small Cell Lung Cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ya ze jiao (15950520087, 15950520087@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) and SAEs (Phase II) (time frame: Approximately within 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07076095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2025.

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