Colorectal Cancer (CRC), Gastric Cancer, Gastrooesophageal Junction Cancer, Non-Small Cell Lung Cancer (NSCLC), Solid Tumor, Squamous Cell Carcinoma of Head and Neck
Conditions
Brief summary
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.
Interventions
DRUGTH9619
Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy. Phase 1b - DOSE EXPANSION Description: Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available.
Sponsors
One-carbon Therapeutics AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of treatment-emergent adverse events (TEAEs) | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of treatment-emergent adverse events (TEAEs) related to treatment, as assessed by the Investigator | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Frequency of serious adverse events (SAEs) | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of serious adverse events (SAEs) per the seriousness criteria defined in the protocol. | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of serious adverse events (SAEs) related to treatment, as assessed by the Investigator | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of out of range clinical laboratory tests (as defined by the clinic) assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of findings on vital signs parameters assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of findings on ECHO/ECG assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of findings during physical examinations assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of treatment emergent adverse events (TEAEs) leading to dose interruptions/reductions and/or discontinuation of treatment | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. |
Countries
France, Spain, United Kingdom
Contacts
CONTACTVictoria Moody
Outcome results
None listed