Trial Title:
IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05774873
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI334 D
Description:
Subjects will receive IBI334 D once a week during the first 28-day cycle (QW, 4 weeks),
then biweekly (or other dose intervals recommended by the Investigator and Sponsor based
on safety, toxicity and PK data), until disease progression, toxicity intolerance,
withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or
treatment duration reaches 24 months, whichever occurs first.
Arm group label:
IBI334 D
Intervention type:
Drug
Intervention name:
IBI334 C
Description:
Subjects will receive IBI334 C once a week during the first 28-day cycle (QW, 4 weeks),
then biweekly (or other dose intervals recommended by the Investigator and Sponsor based
on safety, toxicity and PK data), until disease progression, toxicity intolerance,
withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or
treatment duration reaches 24 months, whichever occurs first.
Arm group label:
IBI334 C
Intervention type:
Drug
Intervention name:
IBI334 A
Description:
Subjects will receive IBI334 A once a week during the first 28-day cycle (QW, 4 weeks),
then biweekly (or other dose intervals recommended by the Investigator and Sponsor based
on safety, toxicity and PK data), until disease progression, toxicity intolerance,
withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or
treatment duration reaches 24 months, whichever occurs first.
Arm group label:
IBI334 A
Intervention type:
Drug
Intervention name:
IBI334 B
Description:
Subjects will receive IBI334 B once a week during the first 28-day cycle (QW, 4 weeks),
then biweekly (or other dose intervals recommended by the Investigator and Sponsor based
on safety, toxicity and PK data), until disease progression, toxicity intolerance,
withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or
treatment duration reaches 24 months, whichever occurs first.
Arm group label:
IBI334 B
Intervention type:
Drug
Intervention name:
IBI334 F
Description:
Subjects will receive IBI334 F once a week during the first 28-day cycle (QW, 4 weeks),
then biweekly (or other dose intervals recommended by the Investigator and Sponsor based
on safety, toxicity and PK data), until disease progression, toxicity intolerance,
withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or
treatment duration reaches 24 months, whichever occurs first.
Arm group label:
IBI334 F
Intervention type:
Drug
Intervention name:
IBI334 E
Description:
Subjects will receive IBI334 C once a week during the first 28-day cycle (QW, 4 weeks),
then biweekly (or other dose intervals recommended by the Investigator and Sponsor based
on safety, toxicity and PK data), until disease progression, toxicity intolerance,
withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or
treatment duration reaches 24 months, whichever occurs first.
Arm group label:
IBI334 E
Summary:
The primary objective of this study to evaluate the safety and tolerability of IBI334 and
determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of
IBI334.
Criteria for eligibility:
Criteria:
Inclusion Criteria：
1. Male or female subjects ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function;
Criteria for dose escalation phase only:
5. 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);
6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1;
Criteria for dose expansion phase only:
7. 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;
8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1.
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 live vaccines within 4 weeks prior to first dose of the study drug or plan
on receiving any live vaccine during the study;
3. Received total pelvic radiotherapy;
4. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
5. Uncontrolled diseases;
6. History of endotracheal or gastrointestinal stent implantation;
7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin
cancer, carcinoma in situ or non-invasive tumor that were cured);
8. Women who are pregnant, have positive results in pregnancy test or are lactating;
9. Not eligible to participate in this study at the discretion of the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Westmead Hospital
Address:
City:
Waratah
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Adnan Nagrial
Phone:
02 8890 5200
Email:
adnan.nagrial@health.nsw.gov.au
Investigator:
Last name:
Bei Yu Sun, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Qing Wen, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Kate Wilkinson, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Lu Ping, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Adnan Nagrial, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Fang Yin Gu, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Lisi Elizabeth Lim, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Cheng Jian Li, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Li Mei Sun, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Na Yi Wang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Chang Yong Zhang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Xiang Zhi Zhuang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Wen Xi Huang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ming Jin Yu, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ping Yu Sun, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Lin Wu, M.D.
Email:
Principal Investigator
Start date:
August 9, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05774873
