Evaluating IBI363 for advanced solid tumors or lymphoma

A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

This study is testing a new treatment called IBI363 to see if it is safe and effective for people with advanced solid tumors or lymphoma.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05460767 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase Ia/Ib study aims to assess the safety, tolerability, and preliminary efficacy of IBI363 in patients with advanced, relapsed, or metastatic solid tumors or lymphoma. The study will determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) through a dose escalation and expansion approach. Participants will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable locally advanced or metastatic solid tumors or lymphomas who have progressed on or are intolerant to standard therapies.

Not a fit: Patients with active brain metastases, spinal cord compression, or those with recent history of thrombosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors or lymphoma who have limited treatment choices.

How similar studies have performed: Other studies evaluating similar immunotherapeutic approaches have shown promising results, indicating potential for success in this area.

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.

Where this trial is running

Hangzhou, Zhejiang

• First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Xiuzhi Yu

Conditions: Solid Tumors or Lymphoma