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A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Recruiting
18 years and older
All
Phase 1

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Overview

The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

Description

A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.

Eligibility

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
  2. ECOG performance status of ≤ 2.
  3. Life expectancy of ≥ 3 months.
  4. The results of the laboratory tests must meet all criteria.

Exclusion Criteria:

  1. Patients have received antitumor therapy during the first 4 weeks before study drug use.
  2. Received a live attenuated vaccine within 4 weeks prior to C1D1.
  3. Known cerebral parenchymal metastasis or meningeal metastasis.
  4. History of serious cardiovascular or cerebrovascular diseases.
  5. Active or recurrent autoimmune diseases.
  6. History of ascites or pleural effusion requiring drainage.
  7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

Study details
    Advanced Solid Tumors

NCT05867420

AskGene Pharma, Inc.

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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