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

Sponsor
AskGene Pharma, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05867420
Collaborator
Jiangsu Aosaikang Pharmaceutical Co., Ltd. (Industry)
104
Enrollment
1
Arm
30
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Biological: ASKG915
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
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.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASKG915

Single or multiple ascending dose of ASKG915.

Biological: ASKG915
ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.

Outcome Measures

Primary Outcome Measures

  1. Dose limiting toxicities (DLTs) [21days]

    To evaluate the safery of ASKG915 in subjects.

  2. Adverse events(AEs) [21days]

    To evaluate the safery of ASKG915 in subjects.

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) [21days]

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  2. Area under the concentration time curve (AUC) [21days]

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  3. Plasma clearance rate (CL) [21days]

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  4. Evaluation of immunogenicity [Up to 2 years from date of treatment start until data cut-off]

    Incidence of anti-drug antibodies (ADA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • AskGene Pharma, Inc.
  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AskGene Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT05867420
Other Study ID Numbers:
  • ASKG915-101
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of May 22, 2023