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

NCT07076095 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IBB0979-201
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events (AEs) and SAEs (Phase II)

  To investigate the safety characteristics.

  Approximately within 36 months

Secondary Outcomes (22)

• Pharmacokinetic (PK) Cmax (Phase II)

  Approximately within 36 months

• Pharmacokinetic (PK) Cmin (Phase II)

  Approximately within 36 months

• Pharmacokinetic (PK) Tmax (Phase II)

  Approximately within 36 months

• Pharmacokinetic (PK) AUC 0-t (Phase II)

  Approximately within 36 months

• Pharmacokinetic (PK) AUC 0-∞ (Phase II)

  Approximately within 36 months

Study Arms (2)

Part 1(Phase IIa)

EXPERIMENTAL

To evaluate the safety and efficacy of IBB0979 in patients with SCLC. Cohort 1: IBB0979 iv Q3W; Cohort 2: IBB0979 iv Q2W.

Drug: IBB0979

Part 2(Phase IIb)

EXPERIMENTAL

To evaluate the safety and efficacy of IBB0979 in combination with topotecan in patients with SCLC.

Drug: IBB0979; Drug: topotecan hydrochloride for injection

Interventions

IBB0979 DRUG

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

Part 1(Phase IIa); Part 2(Phase IIb)

topotecan hydrochloride for injection DRUG

Topotecan hydrochloride will be administered intravenously per prescribing information.

Part 2(Phase IIb)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• SUNHO（China）BioPharmaceutical CO., Ltd.: lead
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital: collaborator

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan; Injections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• ming qi wang

  The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ya ze jiao

CONTACT

15950520087; 15950520087@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 21, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 21, 2025

Record last verified: 2025-07