Clinical trial · Interventional
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
NCT04162327CI-TRIAL-00070733completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI315 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ia stage - IBI315 Dose escalation
- interventionNames
- Drug: IBI315
- type
- EXPERIMENTAL
- label
- Ib stage - IBI315 monotherapy
- interventionNames
- Drug: IBI315
Primary outcomes (4)
- measure
- Area under the plasma concentration-time curve (AUC)
- timeFrame
- up to 9 months
- measure
- Maximum plasma concentration (Cmax)
- timeFrame
- up to 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Written (signed) informed consent. * Life expectancy ≥12 weeks. * Patients with HER2-expressing advanced solid tumor who failed on current standard of care * According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists. * ECOG performance status 0-1. * Adequate organ and marrow function evaluated by laboratory tests as follow: * CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L; * Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN; * Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min; * Urinalysis: urine protein \< 2+ or urine protein in 24-hour urine collection \< 1g; * Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5 * left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography; * Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2; * Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment. * Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood. Exclusion Criteria: * Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue; * Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation; * Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy; * CNS metastasis, spinal compression, or carcinomatous meningitis * Active autoimmune disease or inflammatory disorders. * Primary immunodeficiency diseases; * Pregnant or breast-feeding female.
References
Publications (0)
Data not yet available
No reference posted for this study.