Recruiting
Phase 1
Phase 2

ASKG915

Sponsor:

AskGene Pharma, Inc.

Code:

NCT05867420

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ASKG915

Paclitaxel + Bevacizumab

Fruquintinib

Docetaxel

Study Details

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

Study ID

NCT05867420

Start date

Aug 2, 2023

Status verified date

Jan, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

594 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ASKG915

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).

experimental: ASKG915 combination with SOC

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.

Interventions

ASKG915

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

Paclitaxel + Bevacizumab

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.

Fruquintinib

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.

Docetaxel

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

Primary outcome measure

  • Dose limiting toxicities (DLTs) [ Time Frame: 21days or 28 days ]
  • Adverse events(AEs) [ Time Frame: From the first dose to 30 days after the last dose ]

Central Contacts and Locations

Central contacts

Medical Director

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

Chief Executive Officer

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

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

More Information

Sponsor

AskGene Pharma, Inc.

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • PD-1/IL-15

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AskGene Pharma, Inc. on 2026-01-27.