Loading clinical trials...

RECRUITINGPHASE1/PHASE2

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

A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors

NCT05867420•AskGene Pharma, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

Monotherapy: A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors. Combination therapy: A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

Columbia University Irving Medical Center

New York, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 2, 2023

Primary Completion Date

December 31, 2026

Completion Date

June 30, 2028

Last Updated

January 27, 2026

Enrollment

594

ESTIMATED participants

Conditions

Advanced Solid Tumors

Interventions

ASKG915

BIOLOGICAL

Paclitaxel + Bevacizumab

DRUG

Fruquintinib

DRUG

Docetaxel

DRUG

Contacts

Medical Director

CONTACT

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

Chief Executive Officer

CONTACT

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

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGPHASE1

A Study of ASP1002 in Adults for Treatment of Solid Tumors

NCT05719558

Advanced Solid Tumors

View study

RECRUITINGPHASE1

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Study of ASP1002 in Adults for Treatment of Solid Tumors

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors

A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)