Testing IBI3001 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• START Center for Cancer Research
  Los Angeles, California, United States Recruiting
• START Center for Cancer Research
  East Brunswick, New Jersey, United States Recruiting
• NEXT Oncology
  Dallas, Texas, United States Recruiting
• Wollongong Hospital
  Wollongong, New South Wales, Australia Recruiting
• Cancer Research SA
  Adelaide, South Australia, Australia Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Fortvita Biologics CT.gov Call Center
• Email: ct.govNotifications@fortvitabio.com
• Phone: 650-370-0985

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.