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

ConditionsSolid TumorColorectal Cancer (CRC)Squamous Cell Carcinoma of Head and NeckNon-Small Cell Lung Cancer (NSCLC)Gastrooesophageal Junction CancerGastric Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOne-carbon Therapeutics AB

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • TH9619

    Drug

    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.

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Single arm doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

One-carbon Therapeutics AB

Lead sponsor

Source ClinicalTrials.gov
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