Advanced Solid TumorsPhase 1NCT05509985
A Phase 1 Study of ASKG315 in Patients With Advanced Solid Tumors
A Phase 1 study testing ASKG315 in people with Advanced Solid Tumors, run by AskGene Pharma, Inc. at 2 sites in Australia.
Trial summary
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent (Part 1) and in combination with pembrolizumab (Part 2) in patients with 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?
- ASKG315
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesAustralia
- Study dates
- 9 Aug 2023to 9 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent form.
- Male or female ≥ 18 years of age (at the time signed consent is obtained).
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- Measurable disease, per RECIST v1.1.
- ECOG Performance Status of ≤ 2.
- Life expectancy of ≥3 months, in the opinion of the Investigator.
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- Adequate organ function defined.
- Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) starting with the Screening visit through 90 days + 5 drug half-lives after the last dose of study treatment.
- Negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.
- Willing and able to participate in the trial and comply with all trial requirements.
Who cannot join
- Patients who meet any of the following criteria are not allowed to be enrolled:
- Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.
- Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.
- Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.
- Received systemic glucocorticoid or other immunosuppressant treatment within 14 days prior to C1D1.
- Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 14 days prior to C1D1.
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- Received a live attenuated vaccine within 4 weeks prior to C1D1.
- Received IL-2 or IL-15 therapy within 12 weeks prior to C1D1.
- History of hematologic stem cell transplant or solid organ transplant.
- Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.
- Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.
- Have an active infection that currently requires intravenous anti-infection therapy.
- A history of human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of ≤350 cells/µL at screening. HIV positive patients must be receiving adequate treatment.
- If serological evidence of chronic hepatitis B virus infection (HBV), viral load below the limit of quantification at screening.
- If serological evidence of hepatitis C virus infection (HCV), should have completed curative antiviral treatment and have HCV viral load below the limit of quantification at screening.
- Current clinically significant interstitial lung disease.
- History of serious cardiovascular or cerebrovascular diseases.
- Active or recurrent autoimmune diseases.
- History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated with treatment with an immune checkpoint inhibitor.
- Grade ≥ 3 bleeding .
- Symptomatic with uncontrolled ascites or pleural effusion.
- History of a grade ≥ 3 allergic reaction to protein drugs.
- Known to have alcohol or drug dependence.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent (Part 1) and in combination with pembrolizumab (Part 2) in patients with advanced solid tumors.
Read the detailed description
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 or ASKG315 combined with pembrolizumab will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg. The Part 2 dose escalation consists of 4 planned escalation cohorts.
Part 2 of the study will begin enrolling after Part 1 has successfully and safely dosed all patients in the first two cohorts and followed these patients through the entire DLT period. The starting dose of Part 2 will be determined according to the safety and PK of ASKG315 in Part 1 of the study, but in no case will it exceed the highest dose already safely administered in Part 1 and confirmed as tolerable by the Safety Review Committee in Part 1.
- Conditions
- Advanced Solid Tumors
- Being tested
- ASKG315
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKG315Biological
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.
| Study group | Role | What they receive |
|---|---|---|
| ASKG315 | Experimental | Single or multiple ascending dose of ASKG315 Receives: Biological: ASKG315 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety[DLTs、AEs、ECG]
- Incidence of dose limiting toxicities (DLTs)
- Incidence of adverse events (AEs), laboratory abnormalities, and ECG abnormalities
Measured: 21days
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG315 in subjects.
Measured: 21days
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG315 in subjects.
Measured: 21days
Cytokine
Changes in circulating cytokine levels.
Measured: 21days
Immunocyte
Changes in immunocyte levels by flow cytometry.
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start9 Aug 2023 (estimated)
- Primary completion9 Sep 2023 (estimated)
- Study completion9 Sep 2024 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- Barbara Hickingbottom, MD, Study director, Ask-Gene Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509985
- Sponsor's protocol ID
- ASKG315-101
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD or supporting information available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. 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 ASKG315 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05509985
- Acronym / sponsor ID
- ASKG315-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AskGene Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Study start
- 9 Aug 2023 (estimated)
- Primary completion
- 9 Sep 2023 (estimated)
- Study completion
- 9 Sep 2024 (estimated)
- First posted
- 22 Aug 2022 (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 Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent (Part 1) and in combination with pembrolizumab (Part 2) in patients with advanced solid tumors.
Detailed description
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 or ASKG315 combined with pembrolizumab will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg. The Part 2 dose escalation consists of 4 planned escalation cohorts.
Part 2 of the study will begin enrolling after Part 1 has successfully and safely dosed all patients in the first two cohorts and followed these patients through the entire DLT period. The starting dose of Part 2 will be determined according to the safety and PK of ASKG315 in Part 1 of the study, but in no case will it exceed the highest dose already safely administered in Part 1 and confirmed as tolerable by the Safety Review Committee in Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASKG315 | Experimental | Biological: ASKG315Single or multiple ascending dose of ASKG315 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form.
- Male or female ≥ 18 years of age (at the time signed consent is obtained).
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- Measurable disease, per RECIST v1.1.
- ECOG Performance Status of ≤ 2.
Key exclusion criteria (23 listed)
- Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.
- Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.
- Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.
- Received systemic glucocorticoid or other immunosuppressant treatment within 14 days prior to C1D1.
- Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 14 days prior to C1D1.
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 |
|---|---|---|
| ASKG315Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage. | Biological | ASKG315 |
Primary outcome
Safety[DLTs、AEs、ECG]
Time frame: 21days
1. Incidence of dose limiting toxicities (DLTs) 2. Incidence of adverse events (AEs), laboratory abnormalities, and ECG abnormalities
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 21days
Area under the concentration time curve (AUC)
Time frame: 21days
Cytokine
Time frame: 21days
Immunocyte
Time frame: 21days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. There is no plan to make IPD or supporting information available.
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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. This study is not recruiting at the moment.
Barbara Hickingbottom, MD study director
Ask-Gene Pharma, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASKG315 in people with Advanced Solid Tumors, run by AskGene Pharma, Inc. at 2 sites in Australia.
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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer (805-389-2956, barbara.hickingbottom@ask-gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety[DLTs、AEs、ECG] (time frame: 21days). 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 14 Aug 2023.