A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor

NCT04162327 | Completed Phase 1

• 1 other identifier: CIBI315A101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration-time curve (AUC)

  up to 9 months

• Maximum plasma concentration (Cmax)

  up to 9 months

• Terminal elimination half-life (T1/2)

  up to 9 months

• Apparent volume of distribution (Vd)

  up to 9 months

Secondary Outcomes (3)

• Evaluate receptor occupancy (RO) following single-dose or multi-dose of IBI315

  up to 9 months

• The percentage of participants with anti-drug antibody (ADA) positive after dosing IBI315

  up to 9 months

• The percentage of participants with neutralizing antibody (NAb) positive after dosing IBI315

  up to 9 months

Other Outcomes (4)

• Evaluate the efficacy in participants with different expression level of HER2 in tumor tissue

  up to 9 months

• Evaluate the efficacy in participants with different expression level of PD-L1 in tumor tissue

  up to 9 months

• Evaluate the efficacy in participants with different expression level of tumor infiltrating lymphocyte (TILs)

  up to 9 months

Study Arms (2)

Ia stage - IBI315 Dose escalation

EXPERIMENTAL

Drug: IBI315

Ib stage - IBI315 monotherapy

EXPERIMENTAL

Drug: IBI315

Interventions

IBI315 DRUG

Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

Ia stage - IBI315 Dose escalation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The 307th Hospital of Chinese People's Liberation Army

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 14, 2019
• Study Start: November 26, 2019
• Primary Completion: January 27, 2022
• Study Completion: June 20, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)