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NCT05867420 | RECRUITING | Advanced Solid Tumors

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

AskGene Pharma, Inc.

Brief Summary:

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.

Condition or disease

Advanced Solid Tumors

Intervention/treatment

ASKG915

Phase

PHASE1

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 104 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.
Actual Study Start Date : 2023-08-03
Estimated Primary Completion Date : 2024-03-31
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Location Details

NCT05867420

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232