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

NCT05867420 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ASKG915-101
• Study Type: interventional
• Target: 594
• Locations: 2 countries
• Sites: 4

Brief Summary

The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

PD-1/IL-15

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLTs)

  To evaluate the safery of ASKG915 in subjects.

  21days or 28 days

• Adverse events(AEs)

  To evaluate the safery of ASKG915 in subjects.

  From the first dose to 30 days after the last dose

Secondary Outcomes (7)

• Maximum plasma concentration (Cmax)

  Until treatment discontinuation or for a maximum of 2 years

• Area under the concentration time curve (AUC)

  Until treatment discontinuation or for a maximum of 2 years

• Plasma clearance rate (CL)

  Until treatment discontinuation or for a maximum of 2 years

• Evaluation of immunogenicity

  Until treatment discontinuation or for a maximum of 2 years

• Objective Response Rate (ORR)

  Until disease progression or for a maximum of 2 years

Study Arms (2)

ASKG915

EXPERIMENTAL

For monotherapy (Part A and Part B), subjects will receive ASKG915 via intravenous (IV) infusion at a frequency of once every 3 weeks (Q3W) or once every 4 weeks (Q4W), at either the prespecified dose levels or the levels determined by the Study Review Committee (SRC).

Biological: ASKG915

ASKG915 combination with SOC

EXPERIMENTAL

For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.

Biological: ASKG915; Drug: Paclitaxel + Bevacizumab; Drug: Fruquintinib; Drug: Docetaxel

Interventions

ASKG915 BIOLOGICAL

ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.

ASKG915; ASKG915 combination with SOC

Fruquintinib DRUG

The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle.

ASKG915 combination with SOC

Docetaxel DRUG

Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.

ASKG915 combination with SOC

Paclitaxel + Bevacizumab DRUG

Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle. Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle.

ASKG915 combination with SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG performance status of ≤ 2.
• Life expectancy of ≥ 3 months.
• The results of the laboratory tests must meet all criteria.

You may not qualify if:

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

Sponsors & Collaborators

• AskGene Pharma, Inc.: lead
• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: collaborator

Study Sites (4)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100089, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Bevacizumab; HMPL-013; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jing Chen, MD

  Ask-Gene Pharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

805-389-2956; chenjing@ask-pharm.com

Chief Executive Officer

CONTACT

805-389-2956; jeff.lu@ask-gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 22, 2023
• Study Start: August 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (2); US (2)