Table 1 Two-stage dose escalation schema

From: Mipsagargin, a novel thapsigargin-based PSMA-activated prodrug: results of a first-in-man phase I clinical trial in patients with refractory, advanced or metastatic solid tumours

Dose level

Mipsagargin dose (mg m −2) (days 1, 2, 3)

Stage 1 dose escalation

1

1.2

2

2.5

3

5

4

10

Continue 100% dose increase in subsequent cohorts until initiation of stage 2 dose escalation

Stage 2 dose escalation

1

Last stage 1 dose × 1.67

2

Last dose × 1.5

3

Last dose × 1.33

4

Last dose × 1.33

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