Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
NCT ID: NCT07151040
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2025-08-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm dose
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.
TH9619
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.
Interventions
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TH9619
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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One-carbon Therapeutics AB
INDUSTRY
Responsible Party
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Locations
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Institut Gustave Roussy
Villejuif, , France
Vall D Hebron Institute Of Oncology
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Newcastle University
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-519639-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
TH9619-0101
Identifier Type: -
Identifier Source: org_study_id
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