Testing IBI129 in patients with advanced solid tumors

A Phase 1/2 Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called IBI129 to see if it can help people with advanced solid tumors that can't be surgically removed.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 7 sites (Camperdown, New South Wales and 6 other locations)
• Trial ID: NCT05991349 on ClinicalTrials.gov

What this trial studies

This is a phase 1/2 multicenter trial evaluating IBI129, a new treatment for patients with unresectable, locally advanced, or metastatic solid tumors. The study will first determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of IBI129 through a dose escalation and expansion phase. Following this, a phase 2 portion will assess the efficacy, safety, and tolerability of IBI129 at the RP2D in approximately 182 evaluable subjects. The trial aims to enroll between 22 to 180 subjects in total.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable, locally advanced, or metastatic solid tumors who have at least one evaluable lesion.

Not a fit: Patients who have received anti-tumor therapy within the last four weeks or are refractory to specific antibody drug conjugates may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: While this approach is novel for IBI129, similar studies with other investigational drugs have shown promise in treating advanced solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
3. Male or female subjects ≥ 18 years old;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
5. Anticipated life expectancy of ≥ 12 weeks;
6. Adequate bone marrow and organ function

Exclusion Criteria:

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter.
3. Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
4. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
5. Known symptomatic central nervous system (CNS) metastases.

Where this trial is running

Camperdown, New South Wales and 6 other locations

• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (RECRUITING)
• St George private Hospital — Kogarah, New South Wales, Australia (RECRUITING)
• Wollongong Hospital — Wollongong, New South Wales, Australia (RECRUITING)
• Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)
• The First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)
• Tianjin Medical university cancer institute & Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Serena Dong

Conditions: Solid Tumor