Clinical trial · Interventional
Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors
NCT07151040CI-TRIAL-00101787ODINrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrooesophageal Junction Cancer | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TH9619 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm dose
- description
- Phase 1a (escalation) Single arm dose escalation of TH9619 as monotherapy. Phase 1b (expansion) Single arm dose expansion of TH9619 as monotherapy in selected tumor types.
- interventionNames
- Drug: TH9619
Primary outcomes (11)
- measure
- Frequency of treatment-emergent adverse events (TEAEs)
- timeFrame
- From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
- measure
- Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading
- timeFrame
- From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have given written informed consent * Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer and gastric cancer (including gastroesophageal junction cancer)) * Prior treatment with at least one line of cytotoxic systemic therapy for metastatic/unresectable cancer * Adult patients (≥18 years of age) * Must be willing to comply with study procedures Exclusion Criteria: • History or presence of any clinically significant disorders as judged by the Investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.