A Phase I/II, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors
Study Identifier:
DB-1324-101
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Will Be Recruiting
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Study Summary
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting
Requirements information
Inclusion criteria
- 1. Pathologically documented advanced/unresectable, or metastatic GI tumor. 2. Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available. 3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1. 4. Has a life expectancy of ≥ 3 months. 5. Has an ECOG PS of 0-1. 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment. 7. Has adequate organ functions within 7 days prior to Day 1 of Cycle 1. 8. Has an adequate treatment washout period before Day 1 of Cycle 1. 9. Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers. 10. Other protocol-defined Inclusion criteria apply.
- CFDA:
- 1Adult males or females (defined as those ≥18 years of age at the time of voluntarily signing the informed consent form or the acceptable age as stipulated by local regulations);2Pathologically confirmed advanced/unresectable or metastatic gastrointestinal tumors;3Disease relapse or progression during or after standard systemic therapy, intolerance to standard therapy, or lack of standard therapy available;4Researchers assessed the patients according to the RECIST v1.1 efficacy criteria, requiring at least one measurable lesion;5Expected survival time ≥ 3 months;6ECOG PS score is 0-1;7ECHO or MUGA showed LVEF ≥ 50% within 28 days prior to enrollment;8Good organ function is maintained for the first 7 days of the first cycle;9There is sufficient treatment washout period before day 1 of cycle 1;10Participants were willing to provide archived tumor tissue or undergo tumor biopsy;11Can understand the research procedures and risks outlined in the informed consent form, can provide written consent, and agree to comply with the research requirements and evaluation schedule;12Male participants must agree to use adequate contraception (e.g., double barrier method) during the study period and for at least 4 months after the last dose of the study drug and must not freeze or donate sperm; female participants of reproductive/fertility capacity must agree to use adequate contraception (e.g., double barrier method or intrauterine contraception) during the study period and for at least 7 months after the last dose of the study drug and must not donate eggs or retrieve eggs for their own use.
Exclusion criteria
- 1. Prior treatment with CDH17 targeted therapy. 2. Prior treatment with ADC with topoisomerase I inhibitor. 3. Has chronic enteritis or inflammatory bowel disease. Or has clinically significant bleeding of GI tract or adjacent organs within 1 month prior to the first dose of study treatment. Or has clinically significant obstruction and/or perforation and/or fistulae (including prior GI fistula operation) of GI tract or adjacent tissues within 6 months prior to the first dose of study treatment. 4. Uncontrolled or significant cardiovascular disease. 5. Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment. 6. Has a history of (non-infectious) ILD/pneumonitis that required steroids, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 7. Have a lung-specific intercurrent clinically significant illness. 8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals. 9. Has clinically active brain metastases. 10. Has unresolved toxicities from previous anticancer therapy. 11. Other protocol-defined Exclusion criteria apply.
- CFDA:
- 1Previously received CDH17 targeted therapy;2Previously received ADC therapy containing a topoisomerase I inhibitor;3Patients with chronic enteritis or inflammatory bowel disease; or who have experienced clinically significant gastrointestinal or adjacent organ bleeding within one month prior to the first administration of the study drug; or who have experienced clinically significant obstruction and/or perforation and/or fistula (including previous gastrointestinal fistula surgery) in the gastrointestinal tract or adjacent tissues within six months prior to the first administration of the study drug.4Poorly controlled or severe cardiovascular disease;5Patients with a history of cerebrovascular accident (including transient ischemic attack) within 6 months prior to enrollment.6Those with a history of (non-infectious) ILD/non-infectious pneumonia requiring steroid treatment, or currently having ILD/non-infectious pneumonia, or having suspected ILD/non-infectious pneumonia that cannot be ruled out by imaging during screening;7Clinically significant lung-specific complications;8There is an uncontrolled infection that requires intravenous antibiotics, antiviral drugs, or antifungal drugs;9Known HIV, active HBV, or HCV infection;10Women who are breastfeeding (and women who are willing to temporarily stop breastfeeding will also be excluded), or women who have been confirmed to be pregnant by a serum pregnancy test within 7 days before day 1 of cycle 1;11It has clinically active brain metastases;12The toxic effects of previous anti-tumor treatments have not subsided;13Patients with primary malignant tumors within 5 years prior to enrollment are excluded, except for cervical carcinoma in situ, localized squamous cell carcinoma of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Recruiting
Condition(s) Treated at Site
Gastric