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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07623369 | A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors | PHASE1 | NOT YET_RECRUITING | 56 | — | — | Jun 1, 2026 | Aug 1, 2028 | Jun 3, 2026 | - | — |
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs). and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
| Arm | Type | Description |
|---|---|---|
| Phase 1a Part 1 : Dose Escalation | EXPERIMENTAL | Participants with advanced solid tumors will receive escalating doses of HH160 |
| Phase 1a Part 2: Safety Expansion | EXPERIMENTAL | Participants with selected advanced solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal carcinoma (CRC), and other tumor types, will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability. |
| Name | Type | Description |
|---|---|---|
| HH160 | DRUG | Administered by intravenous infusion every 3 weeks (Q3W) |
Key Inclusion Criteria 1. Adults aged 18 to 75 years with signed informed consent. 2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements. 3. At least 1 measurable lesion per RECIST v1.1. 4. Eastern Cooperative Oncology Group Performance Statu...
| 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 |