Clinical trial NCT05460767: Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
Official title: A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors or Lymphoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).

Detailed description: This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D). The phase Ia part consists of the dose escalation and PD marker exploration part. The phase Ib part consists of the dose expansion part.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, ≥ 18 years
2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
3. Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
4. Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Expected survival time ≥ 3 months.

Exclusion Criteria:

1. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
2. Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
3. Active uncontrolled bleeding or a known bleeding diathesis.
4. Subjects with massive pleural effusion or massive ascites.

Primary outcomes:
measure: Number of dose-limiting toxicity (DLT)
timeFrame: 21 days during the first 3-week cycle
measure: incidence of adverse enents (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in vital signs
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in hematology parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in clinical chemistry parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in routine urinalysis parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in ECG parameters
timeFrame: up to 90 days after the last administration
Secondary outcomes:
measure: maximum concentration (Cmax)
timeFrame: Up to 2 years
measure: area under the curve (AUC)
timeFrame: Up to 2 years
measure: clearance (CL)
timeFrame: Up to 2 years
measure: half-life (t1/2) of IBI363
timeFrame: Up to 2 years
measure: volume of distribution (V)
timeFrame: Up to 2 years
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: time to response (TTR)
timeFrame: Up to 2 years
measure: duration of response (DoR)
timeFrame: Up to 2 years
measure: disease control rate (DCR)
timeFrame: Up to 2 years
measure: progression-free survival (PFS)
timeFrame: Up to 2 years
measure: 6-month and 1-year PFS rate
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
measure: 6-month and 1-year OS rate
timeFrame: Up to 2 years
measure: The incidence of ADA and NAb of IBI363
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: