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Trial Title:
A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT06577376
Condition:
Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Expressing Human Epidermal Growth Factor Receptor-2 (HER-2)
Disease Progression After Receiving at Least One and at Most Two Lines of Systemic Treatment in the Past
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Disease Progression
Paclitaxel
Docetaxel
Irinotecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
In the dose escalation phase, a "3+3" approach is used to explore the safety and
tolerability of subjects, and in the randomized controlled phase, the efficacy of
different combination doses is explored
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DP303c
Description:
DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody
coupled to one MMAE via an enzyme specific linker
Arm group label:
DP303c RP2D + irinotecan liposomes RP2D
Arm group label:
DP303c injection, dose level 1, Q2W + simmitinib tablets, dose level 2, D1-D21, Q4W
Arm group label:
DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 1, D1-D21, Q4W
Arm group label:
DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W
Arm group label:
DP303c injection, dose level 2, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W
Intervention type:
Drug
Intervention name:
Simmitinib tablets
Description:
A novel small molecule inhibitor targeting fibroblast growth factor receptor (FGFR),
vascular endothelial growth factor receptor (VEGFR2, KDR), and colony-stimulating factor
1 receptor (CSF-1R)
Arm group label:
DP303c injection, dose level 1, Q2W + simmitinib tablets, dose level 2, D1-D21, Q4W
Arm group label:
DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 1, D1-D21, Q4W
Arm group label:
DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W
Arm group label:
DP303c injection, dose level 2, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W
Intervention type:
Drug
Intervention name:
Irinotecan liposomes
Description:
A chemotherapy
Arm group label:
DP303c RP2D + irinotecan liposomes RP2D
Intervention type:
Drug
Intervention name:
Paclitaxel or docetaxel or irinotecan
Description:
Paclitaxel or docetaxel or irinotecan is used as a control.
Arm group label:
Single agent chemotherapy chosen by researchers
Summary:
This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose
escalation phase of DP303c combined with simmitinib, as well as the randomized controlled
trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose
escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT
stage of DP303c combined with irinotecan liposomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Aged 18-75 (including) years old; 2. Gastric adenocarcinoma or gastroesophageal
junction adenocarcinoma diagnosed by histology or cytology; 3. Disease
progression after receiving one or two lines of systemic treatment in the past
(first-line treatment must be platinum/fluorouracil combination chemotherapy
with or without immune checkpoint inhibitors); 4. There should be at least one
measurable lesion according to the response evaluation criteria in solid tumors
(RECIST v1.1),; 5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or
1+(applicable to Cohort 2); 6. Adequate organ or bone marrow function
Exclusion Criteria:
- *Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-75 (including) years old;
2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by
histology or cytology;
3. Disease progression after receiving one or two lines of systemic treatment in the
past (first-line treatment must be platinum/fluorouracil combination chemotherapy
with or without immune checkpoint inhibitors);
4. There should be at least one measurable lesion according to the response evaluation
criteria in solid tumors (RECIST v1.1),;
5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort
2);
6. Adequate organ or bone marrow function
Exclusion Criteria:
1. Patients who have experienced toxicity during previous treatment with trastuzumab or
trastuzumab biosimilars, resulting in permanent discontinuation of trastuzumab or
trastuzumab biosimilars;
2. Patients with a history of allergies to any component of DP303c and deemed severe by
the researchers
3. There is uncontrolled serosal fluid accumulation that requires frequent drainage or
medical intervention;
4. Active leptomeningeal disease or uncontrolled CNS metastasis;
5. Has a history of serious cardiovascular and cerebrovascular diseases;
6. There was a peripheral neuropathy of grade ≥ 2 (refer to NCI CTCAE 5.0) prior to
enrollment;
7. History of gastrointestinal perforation and/or fistula within 6 months of first use
of medication;
8. Inability to swallow medication orally or presence of clinically significant
gastrointestinal diseases;
9. Urine protein ≥++ and 24-hour urine protein quantification>1.0 g during screening
period;
10. There are eye diseases that require intervention, such as corneal diseases, retinal
diseases, or active eye infections;
11. Used CYP3A4 strong inhibitors or CYP3A4 strong inducers 14 days before the first
medication ;
12. Used UGT1A1 strong inhibitor before first medication and wash-off period is less
than 5 half-lives.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 26, 2024
Completion date:
August 26, 2027
Lead sponsor:
Agency:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Agency class:
Industry
Source:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06577376
