A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

ConditionsLocalized 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

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Aged 18-75 (including) years old;

Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;

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);

There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),;

Trial design

Design model

Parallel

Treatments tested in this trial

DP303c
Drug
DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody coupled to one MMAE via an enzyme specific linker
Simmitinib tablets
Drug
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)
Irinotecan liposomes
Drug
A chemotherapy
Paclitaxel or docetaxel or irinotecan
Drug
Paclitaxel or docetaxel or irinotecan is used as a control.

Treatment groups

252 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 1, D1-D21, Q4WExperimental treatment 2 interventions

Group B: DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4WExperimental treatment 2 interventions

Group C: DP303c injection, dose level 1, Q2W + simmitinib tablets, dose level 2, D1-D21, Q4WExperimental treatment 2 interventions

Group D: DP303c injection, dose level 2, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4WExperimental treatment 2 interventions

Group E: DP303c RP2D + irinotecan liposomes RP2DExperimental treatment 2 interventions

Group F: Single agent chemotherapy chosen by researchersActive comparator 1 intervention