Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07056777 | Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer | PHASE1 | RECRUITING | 186 | — | — | Mar 25, 2025 | Jun 30, 2026 | Jan 13, 2026 | 1 | China |
Dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
The incidence and severity of AEs graded according to NCI-CTCAE v5.0.
As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.
A recommended phase 2 dose will be determined based on safety data.
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| DR30206+Oxaliplatin+Capecitabine | EXPERIMENTAL | DR30206 20mpk Q3W or DR30206 30mpk Q3W; Oxaliplatin 130 mg/m2, d1, Q3W; Capecitabine 1000 mg/m2, bid, d1-14, Q3W; |
| DR30206+Oxaliplatin+Calcium Folinate+5-FU | EXPERIMENTAL | DR30206 15mpk Q2W or DR30206 20mpk Q2W; Oxaliplatin 85 mg/m2, d1, Q2W; Calcium Folinate 400mg/m2, d1, Q2W; 5-FU 400mg/m2, d1 and 5-FU 1200mg/m2, d2-3, Q2W. |
| DR30206+Irinotecan+Calcium Folinate+5-FU | EXPERIMENTAL | DR30206 15mpk Q2W or DR30206 20mpk Q2W; Irinotecan 180 mg/m2, d1, Q2W; Calcium Folinate 400mg/m2, d1, Q2W; 5-FU 400mg/m2, d1 and 5-FU 1200mg/m2, d2-3, Q2W. |
| Name | Type | Description |
|---|---|---|
| DR30206 | DRUG | Subjects receive DR30206 intravenously |
| Oxaliplatin | DRUG | Subjects receive Oxaliplatin intravenously |
| Capecitabine | DRUG | Subjects take Capecitabine orally |
| Calcium Folinate | DRUG | Subjects receive Calcium Folinate intravenously |
| 5-FU | DRUG | Subjects receive 5-FU by Intravenous Bolus |
| Irinotecan (CPT-11) | DRUG | Subjects receive Irinotecan intravenously |
Inclusion Criteria: 1. Voluntarily sign a written informed consent form. 2. Patients must be ≥ 18 and ≤75 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Expected survival period of at least 3 months. 5. Depending on the tumor type, subjects must meet the...