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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02998567 | Combination Study of Guadecitabine/ASTX727 and Pembrolizumab | PHASE1 | ACTIVE NOT_RECRUITING | 60 | — | — | Jan 26, 2017 | Sep 1, 2026 | May 12, 2026 | 2 | United Kingdom |
To establish a maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of guadecitabine and pembrolizumab in patients with advanced solid tumours. To determine the maximum dose at which no more than 1 of 6 patients at the same dose level experience a drug related toxicity (DLT), as defined in section 3.1.4 of the protocol.
To assess the safety and toxicity profile of the combination of guadecitabine and pembrolizumab. To determine causality and grading severity of each adverse event by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
| Arm | Type | Description |
|---|---|---|
| Escalation | EXPERIMENTAL | Fixed dose of Pembrolizumab with escalating dose of Guadecitabine to establish the phase 2 recommended dose. |
| Expansion | EXPERIMENTAL | Continuation of the Guadecitabine and Pembrolizumab dose established in arm 1: expansion in the recommended patient population. |
| B2: Lung Expansion | EXPERIMENTAL | To further explore the safety and activity of the combination of ASTX727 (replacement of guadecitabine to an oral dose tablet) with pembrolizumab in patients with NSCLC with primary or secondary resistance to PD-1/PD-L1 inhibitors. |
| Name | Type | Description |
|---|---|---|
| Guadecitabine | DRUG | In arm 1 (escalation) and 2 (expansion). |
| Pembrolizumab | DRUG | In arm 1 (escalation) and 2 (expansion). |
| ASTX727 | DRUG | In arm B2 (lung expansion) replacing guadecitabine |
Inclusion Criteria: 1. Part A and B1/2: Histologically or cytologically confirmed advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient. Part B1: Histologically or cytologically confirmed advanced solid tu...