Advanced Solid TumorsPhase 1/2NCT05867420
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
A Phase 1/2 study testing ASKG915, Paclitaxel + Bevacizumab and Fruquintinib in people with Advanced Solid Tumors, run by AskGene Pharma, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ASKG915, Paclitaxel + Bevacizumab and Fruquintinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 Aug 2023to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Mark Stein, MD
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Jason Luke, MD
China2 sites, 2 recruiting
- Not yet recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100089
Lin Shen, MD, 86-13911219511, doctorshenlin@sina.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Xiaohua Wu, MD, 86-13601772486, xu.xh@fudan.edu.cn
About this study
Official title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- ASKG915, Paclitaxel + Bevacizumab, Fruquintinib, Docetaxel
- Keywords
- PD-1/IL-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKG915Biological
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
Paclitaxel + BevacizumabDrug
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.
FruquintinibDrug
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.
DocetaxelDrug
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Biological: ASKG915; Drug: Paclitaxel + Bevacizumab; Drug: Fruquintinib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs)
To evaluate the safery of ASKG915 in subjects.
Measured: 21days or 28 days
Adverse events(AEs)
To evaluate the safery of ASKG915 in subjects.
Measured: From the first dose to 30 days after the last dose
Secondary outcomes (7)
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Measured: Until treatment discontinuation or for a maximum of 2 years
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Measured: Until treatment discontinuation or for a maximum of 2 years
Plasma clearance rate (CL)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Measured: Until treatment discontinuation or for a maximum of 2 years
Evaluation of immunogenicity
Incidence of anti-drug antibodies (ADA)
Measured: Until treatment discontinuation or for a maximum of 2 years
Objective Response Rate (ORR)
The percentage of patients having a best overall response of complete response (CR) or partial response (PR)
Measured: Until disease progression or for a maximum of 2 years
Duration of response (DOR)
The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death
Measured: Until disease progression or for a maximum of 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose of study treatment until the date of progressive disease or death, whichever is earlier
Measured: Until disease progression or for a maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start2 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AskGene Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jing Chen, MD, Study director, Ask-Gene Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867420
- Sponsor's protocol ID
- ASKG915-101
- Status last verified
- Jan 2026
- First submitted
- 4 May 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05867420
- Acronym / sponsor ID
- ASKG915-101
- Conditions
- Advanced Solid Tumors
- Keywords
- PD-1/IL-15
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- AskGene Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASKG915 | Experimental | Biological: ASKG915For 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). |
| ASKG915 combination with SOC | Experimental | Biological: ASKG915, Drug: Paclitaxel + Bevacizumab, Drug: Fruquintinib, Drug: DocetaxelFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASKG915ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle. | Biological | ASKG915, ASKG915 combination with SOC |
| Paclitaxel + BevacizumabPaclitaxel 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. | Drug | ASKG915 combination with SOC |
| FruquintinibThe recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle. | Drug | ASKG915 combination with SOC |
| DocetaxelDocetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle. | Drug | ASKG915 combination with SOC |
Primary outcome
Dose limiting toxicities (DLTs)
Time frame: 21days or 28 days
To evaluate the safery of ASKG915 in subjects.
Adverse events(AEs)
Time frame: From the first dose to 30 days after the last dose
To evaluate the safery of ASKG915 in subjects.
7 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Area under the concentration time curve (AUC)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Plasma clearance rate (CL)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Evaluation of immunogenicity
Time frame: Until treatment discontinuation or for a maximum of 2 years
Objective Response Rate (ORR)
Time frame: Until disease progression or for a maximum of 2 years
Duration of response (DOR)
Time frame: Until disease progression or for a maximum of 2 years
Progression-free survival (PFS)
Time frame: Until disease progression or for a maximum of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Chen, MD study director
Ask-Gene Pharma, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASKG915, Paclitaxel + Bevacizumab and Fruquintinib in people with Advanced Solid Tumors, run by AskGene Pharma, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (805-389-2956, chenjing@ask-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLTs) (time frame: 21days or 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.