To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of IBI363 in Subjects With Advanced Solid Malignancies
NCT ID:
NCT06281678
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI363
Description:
IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3
weeks. Subjects will receive study medication until disease progression, toxicity
intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any
other reason that requires discontinuation of the study treatment, whichever occurs
first.
Arm group label:
IBI363
Summary:
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy,
safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory
solid malignancies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects have 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. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 3 months;
Exclusion Criteria:
1. Inadequate bone marrow and organ function;
2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule
therapy (standard or investigational) within 2 weeks or 5 plasma half-lives.
Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study
drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks
prior to first dose
3. Received live vaccines within 28 days prior to first administration of the study
drug or plan on receiving any live vaccine during the study;
4. Has adverse reactions resulting from previous antitumor therapies, which have not
resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia,
fatigue, pigmentation and other conditions with no safety risk according to
investigator' discretion) or baseline prior to the first dose of the study drug;
5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery
according to investigator' discretion, excluding needle biopsy) within 4 weeks prior
to the first dose of the study drug, or who are expected to undergo major surgery
during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology Consultants P.A.
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mahran Shoukier
Phone:
713-600-0913
Email:
mshoukier@oncologyconsu.com
Contact backup:
Last name:
Bryand Osorio
Phone:
1-713-600-0913
Phone ext:
1008
Email:
bosorio@oncologyconsultants.com
Investigator:
Last name:
Nashat Gabrail, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Yoanna Pumpalova, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Saqib Abbasi, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Shou-Ching Tang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Dipesh Uprety, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Chao Yin, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ketan Doshi, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Katy Tsai, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Piha-Paul Sarina, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Jessica Hawley, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Mahran Shoukier, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Faisal Musa, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Laura Nadeau, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Chintan Gandhi, M.D.
Email:
Principal Investigator
Start date:
April 8, 2024
Completion date:
December 31, 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/NCT06281678
