Testing IBI3001 in patients with advanced solid tumors

A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called IBI3001 to see if it can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 5 sites (Wollongong, New South Wales and 4 other locations)
• Trial ID: NCT06349408 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial is an open-label, multicenter study evaluating the safety and preliminary efficacy of IBI3001 in participants with unresectable, locally advanced, or metastatic solid tumors. The study aims to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of IBI3001. Participants will be monitored for their response to the treatment, which is intended for those who have not responded to or cannot tolerate standard therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable, locally advanced or metastatic solid tumors that are refractory to standard treatments.

Not a fit: Patients who have progressed on or are intolerant to specific antibody-drug conjugates containing Exatecan 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 that are difficult to treat.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in targeting advanced solid tumors with new therapies.

Eligibility criteria

Key Inclusion Criteria:

1. Male or female participants ≥ 18 years old;
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Has an anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function:
5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Key Exclusion Criteria:

1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
7. History of endotracheal or gastrointestinal stent implantation;
8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
9. Esophageal or gastric varices requiring immediate intervention;
10. Not eligible to participate in this study at the discretion of the investigator;
11. Do not have adequate treatment washout period before study drug administration. -

Where this trial is running

Wollongong, New South Wales and 4 other locations

• Wollongong Public — Wollongong, New South Wales, Australia (RECRUITING)
• Cancer Research SA — Adelaide, South Australia, Australia (RECRUITING)
• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of zhejiang University School of Medicine — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Sujie Zhang

Conditions: Locally Advanced Solid Tumor