Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study is assessing how safe and tolerable a new drug (called IBI334) is, and also aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) of the drug is.
Eligible participants will be assigned to one of six treatment arms. In each arm, participants will receive the study drug IBI334 once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals as recommended by the researchers).
Conditions
This trial is treating people with advanced or metastatic solid cancers
Eligibility
Inclusion
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
-
Adequate bone marrow and organ function;
Criteria for dose escalation phase only:
- 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 (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype colorectal cancer);
-
At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Criteria for dose expansion phase only:
- Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion
- Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
- Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
- Received total pelvic radiotherapy;
- Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- Uncontrolled diseases;
- History of endotracheal or gastrointestinal stent implantation;
- Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured);
- Women who are pregnant, have positive results in pregnancy test or are lactating;
- Not eligible to participate in this study at the discretion of the investigator.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Scientific Title
A Phase 1 Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
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