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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05205850 | A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors | PHASE1 | RECRUITING | 135 | — | — | Mar 3, 2022 | Dec 1, 2025 | Jan 27, 2025 | 2 | China |
In the DLT evaluation window (observation period 1-28 days after the first administration), according to the NCI-CTCAE v5.0 grading standard, the investigator or the sponsor believes that toxic reaction which are reasonably related to RC118 treatment
Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
| Arm | Type | Description |
|---|---|---|
| RC118-ADC | EXPERIMENTAL | Participants will be allocated to one of the following dose groups: 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3.0mg/kg, and receive a treatment of RC118-ADC followed by 14 days of dose limited toxicity (DLT) observation period. |
| Name | Type | Description |
|---|---|---|
| RC118-ADC | DRUG | RC118 for injection is a novel antibody-drug conjugate, with a Claudin 18.2-targeting antibody and a microtube inhibitor |
Inclusion Criteria: 1. Volunteer to participate in this study and sign written informed consent 2. 18 years old ≤ age ≤ 75 years old, no gender limit 3. ECOG physical status score is 0 or 1 point 4. The expected survival time exceeds 12 weeks 5. Standard treatment is ineffective (disease progressio...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |