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Recruiting NCT07151040

Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

Phase I / Phase II Interventional Solid Tumor Colorectal Cancer (CRC) Squamous Cell Carcinoma of Head and Neck Non-Small Cell Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TH9619.
Who it may be relevant to
Registry conditions: Solid Tumor, Colorectal Cancer (CRC), Squamous Cell Carcinoma of Head and Neck, Non-Small Cell Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Spain, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug 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.

Primary outcome measures

  • Frequency of treatment-emergent adverse events (TEAEs) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Vall D Hebron Institute Of Oncology — Barcelona
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid
France · 1 center
  • Institut Gustave Roussy — Villejuif
United Kingdom · 1 center
  • Newcastle University — Newcastle upon Tyne

Identifiers

NCT: NCT07151040 · TH9619-0101 · 2024-519639-40-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗