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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05083481 | A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 226 | — | — | Oct 19, 2021 | Jun 30, 2026 | May 5, 2026 | 30 | United States, China +4 |
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness.
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant temporally associated with the use of study IP, whether or not considered related to the study IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade changes from baseline to highest post-baseline grade will be assessed.
Number of participants with potentially clinically significant vital sign values.
Number of participants with potentially clinically significant ECG values.
| Arm | Type | Description |
|---|---|---|
| ASP1570 Monotherapy Dose Escalation (Part 1) | EXPERIMENTAL | Participants will receive daily dose of ASP1570 in a 21-day cycle. |
| ASP1570 + pembrolizumab Combination therapy Dose Escalation (Part 1) | EXPERIMENTAL | Participants will receive daily dose of ASP1570 in a 21-day cycle. pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle. |
| ASP1570 + Docetaxel Combination therapy Dose Expansion - NSCLC 2L+ (Part 2) | EXPERIMENTAL | Participants who have NSCLC will receive RP2D of ASP1570 daily in a 21-day cycle. Docetaxel will be administered every 6 weeks on day 1 of every other ASP1570 cycle. |
| ASP1570 Monotherapy Dose Expansion - Food Effect (Part 2) | EXPERIMENTAL | Participants will receive RP2D of ASP1570 after the meal in a 21-day cycle. This cohort will be opened at the discretion of the sponsor. |
| ASP1570 Monotherapy Dose Expansion - Intermittent dosing (Part 2) | EXPERIMENTAL | Participants will receive RP2D of ASP1570 with some periodical drug holiday in a 21-day cycle. This cohort will be opened at the discretion of the sponsor. |
| ASP1570 Monotherapy Dose Expansion - Stepwise dosing (Part 2) | EXPERIMENTAL | Participants will receive ASP1570 administered by intra-subject dose escalation with gradual multiple dose steps (e.g., 3 steps) and increased dose up to RP2D in a 21-day cycle. This cohort will be opened at the discretion of the sponsor. |
| ASP1570 Monotherapy Dose Expansion Microsatellite stable - colorectal cancer (MSS-CRC) (Part 2) | EXPERIMENTAL | Participants who have MSS-CRC will receive ASP1570 in a 21-day cycle. |
| ASP1570 + TAS-102 + Bevacizumab Combination therapy Dose Expansion - MSS-CRC 3L+ (Part 2) | EXPERIMENTAL | Participants who have MSS-CRC will receive ASP1570 daily in a 28-day cycle. TAS-102 (Trifluridine + Tipiracil) will be administered on days 1 through 5 and days 8 through 12 of each 28-day cycle. Bevacizumab will be administered every 2 weeks. |
| ASP1570 Monotherapy Dose Expansion NSCLC (Part 2) | EXPERIMENTAL | Participants who have NSCLC will receive ASP1570 in a 21-day cycle. |
| ASP1570 + Pembrolizumab + Pemetrexed + Carboplatin CTDE - NSCLC 1L (Part 2) | EXPERIMENTAL | Participants who have NSCLC will receive ASP1570 daily in a 21-day cycle. Pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle. Pemetrexed and carboplatin will be administered on day 1 of each 21-day cycle. Combination therapy Dose Expansion (CTDE) |
| ASP1570 + Bevacizumab + mFOLFOX6 or FOLFIRI Combination therapy Dose Expansion - MSS-CRC 2L (Part 2) | EXPERIMENTAL | Participants who have MSS-CRC will receive ASP1570 in a 14-day cycle. Bevacizumab, will be administered every 2 weeks. mFOLFOX6 (oxaliplatin, Leucovorin, 5-fluorouracil) or FOLFIRI (Leucovorin, 5-Fluorouracil, Irinotecan) will administered every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| ASP1570 | DRUG | Oral tablet |
| pembrolizumab | DRUG | Intravenous Infusion |
| Trifluridine + Tipiracil | DRUG | Oral Administration |
| Bevacizumab | DRUG | Intravenous Infusion |
| Docetaxel | DRUG | Intravenous Infusion |
| Oxaliplatin | DRUG | Intravenous Infusion |
| Leucovorin | DRUG | Intravenous Infusion |
| 5-Fluorouracil | DRUG | Intravenous Infusion |
| Irinotecan | DRUG | Intravenous Infusion |
| Pemetrexed | DRUG | Intravenous Infusion |
| Carboplatin | DRUG | Intravenous Infusion |
Inclusion Criteria: * Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy which is confirmed by available pathology records or current biopsy. * Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situ...
| 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 |