Trial intelligence / Profile preview

IBC0966 in Advanced Malignant Tumors

NCT04980690Phase 2

Key facts

Status: Recruiting
Start: Aug 2021
Primary completion: Dec 2024
Countries: 1
Sponsor: SUNHO BioPharmaceutical
Modality: Fc-Fusion Proteins

Drugs: IBC-0966
Conditions: cancertriple negative breast cancer (TNBC)non-small cell lung cancer (NSCLC)head and neck squamous cell carcinoma (HNSCC)peripheral T-cell lymphoma (PTCL)

Overview

Phase 2, open-label trial of IBC-0966 in cancer, triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and 2 more (7 arms), sponsored by SUNHO BioPharmaceutical. Primary endpoints: Frequency of adverse events (AEs) and SAEs, Dose limiting toxicities and 1 more. Started Aug 2021; status: recruiting.

Design

7 arms

Study design: Non-randomizedOpen-label

Phase Ia - Acceleration
Single patient cohorts with 100% dose increments.
Phase Ia - 3+3
3+3 dose escalation design.
Phase Ib - Dose Extension
Extension at specific dose levels.
Phase IIa - TNBC
Triple-negative breast cancer cohort.
Phase IIa - NSCLC
Non-small cell lung cancer cohort.
Phase IIa - HNSCC
Head and neck squamous cell carcinoma cohort.

1 more in the full profile.

Who it enrols

Patients with advanced malignant tumors who have failed standard treatments. Specific cohorts include Triple-Negative Breast Cancer, NSCLC without driver mutations, HNSCC, and Peripheral T-cell Lymphoma. Prior PD-1/PD-L1 or CD47/SIRPα therapy is excluded for Phase Ia/Ib.

Endpoints

Primary

Frequency of adverse events (AEs) and SAEs3 months after end event visit
Dose limiting toxicities28 days after first dose
Objective response rateUp to 2 years

Secondary

Pharmacokinetic (PK) CmaxUp to 2 years
Pharmacokinetic (PK) TmaxUp to 2 years
Pharmacokinetic (PK) AUC 0-tUp to 2 years
Pharmacokinetic (PK) AUC 0-infUp to 2 years
Pharmacokinetic (PK) t1/2Up to 2 years
Objective response rate in dose escalationUp to 2 years
Immunogenicity of IBC09663 months after end event visit
Progression free survivalUp to 2 years

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