Advanced Solid TumorsPhase 1NCT05287399
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
A Phase 1 study testing ASC61 200 mg 1, ASC61 200 mg 2 and ASC61 300 mg in people with Advanced Solid Tumors, run by Ascletis Pharmaceuticals Co., Ltd. at 4 sites in United States.
Trial summary
This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for… 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?
- ASC61 200 mg 1, ASC61 200 mg 2 and ASC61 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Aug 2022to 17 Jan 2025
- 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
- Adults ≥ 18 years of age at the time of screening
- Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion, as defined by RECIST 1.1
Who cannot join
- Known symptomatic brain metastases requiring steroids
- Known history of another primary solid tumor
- Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs
- Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis
- Gastrointestinal disorders that might affect drug absorption
Trial locations and contacts
4 sites in 1 country.
United States4 sites
California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, 92024
California Cancer Associates for Research & Excellence (cCARE)
Fresno, California, 93720
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
California Cancer Associates for Research & Excellence (cCARE)
San Marcos, California, 92069
About this study
Official title: An Open-Label, Multicenter, Single-Arm Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61 in Subjects With Advanced Solid Tumors
This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.
Read the detailed description
Except for the first starting dose of 200 mg once daily (QD), a traditional "3 + 3 design" will be followed for dose finding with dose escalation and/or de escalation as appropriate. Each subject in each dose cohort will use 2 dose schedules: single dose on Day 1 (D1), and repeated doses on daily basis for 28 days starting from Day 3. One treatment cycle is 28 days. Subjects will be sequentially enrolled in a dose-escalation design to receive ASC61 at initial dose of 200 mg QD. Subsequent doses of 200 mg twice a day (BID), 300 mg BID, 400 mg BID, 600 mg and 800 mg BID are planned.
- Conditions
- Advanced Solid Tumors
- Being tested
- ASC61 200 mg 1, ASC61 200 mg 2, ASC61 300 mg, ASC61 400 mg, ASC61 600 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC61 200 mg 1Drug
200mg of ASC61 orally once daily for cycles of 28 days
ASC61 200 mg 2Drug
200 mg of ASC61 orally twice daily for cycles of 28 days
ASC61 300 mgDrug
300 mg of ASC61 orally twice daily for cycles of 28 days
ASC61 400 mgDrug
400 mg of ASC61 orally twice daily for cycles of 28 days
ASC61 600 mgDrug
600 mg of ASC61 orally twice daily for cycles of 28 days
ASC61 800 mgDrug
800 mg of ASC61 orally twice daily for cycles of 28 days
| Study group | Role | What they receive |
|---|---|---|
| ASC61 200 mg 1 | Experimental | ASC61 200 mg orally once Receives: Drug: ASC61 200 mg 1 |
| ASC61 200 mg 2 | Experimental | ASC61 200 mg orally twice daily Receives: Drug: ASC61 200 mg 2 |
| ASC61 300 mg | Experimental | ASC61 300 mg orally twice daily Receives: Drug: ASC61 300 mg |
| ASC61 400 mg | Experimental | ASC61 400 mg orally twice daily Receives: Drug: ASC61 400 mg |
| ASC61 600 mg | Experimental | ASC61 600 mg orally twice daily Receives: Drug: ASC61 600 mg |
| ASC61 800 mg | Experimental | ASC61 800 mg orally twice daily Receives: Drug: ASC61 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience DLTs
The primary endpoint of this study is the proportion of the patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following treatment of PD1-PDL1 inhibitor
Measured: From baseline to 28 days of treatment
Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
Maximum serum concentration (Cmax) of ASC61, Area under the serum concentrations of ASC61 versus time curve (AUC) and Half-life (t1/2) of serum concentrations of ASC61)
Measured: From first dose of ASC61 (Day 1) until 90 days after the last dose
Secondary outcomes (4)
Percentage of ASC61 subjects with a best response of Complete Response or Partial Response (Objective Response Rate)
Measured: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
Percentage of ASC61 subjects with Complete Response, Partial Response, or Stable Disease (Disease Control Rate)
Measured: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
Length of time that ASC61 subjects continue to respond to treatment without disease progression (Duration of response)
Measured: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 1 year)
Length of time between first dosing and disease progression (Progression-Free survival)
Measured: From first dose of ASC61 (Day 1) until death (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start2 Aug 2022
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287399
- Sponsor's protocol ID
- ASC61-101
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Single-Arm Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05287399
- Acronym / sponsor ID
- ASC61-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 18 Mar 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.
This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.
Detailed description
Except for the first starting dose of 200 mg once daily (QD), a traditional "3 + 3 design" will be followed for dose finding with dose escalation and/or de escalation as appropriate. Each subject in each dose cohort will use 2 dose schedules: single dose on Day 1 (D1), and repeated doses on daily basis for 28 days starting from Day 3. One treatment cycle is 28 days. Subjects will be sequentially enrolled in a dose-escalation design to receive ASC61 at initial dose of 200 mg QD. Subsequent doses of 200 mg twice a day (BID), 300 mg BID, 400 mg BID, 600 mg and 800 mg BID are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ASC61 200 mg 1 | Experimental | Drug: ASC61 200 mg 1ASC61 200 mg orally once |
| ASC61 200 mg 2 | Experimental | Drug: ASC61 200 mg 2ASC61 200 mg orally twice daily |
| ASC61 300 mg | Experimental | Drug: ASC61 300 mgASC61 300 mg orally twice daily |
| ASC61 400 mg | Experimental | Drug: ASC61 400 mgASC61 400 mg orally twice daily |
| ASC61 600 mg | Experimental | Drug: ASC61 600 mgASC61 600 mg orally twice daily |
| ASC61 800 mg | Experimental | Drug: ASC61 800 mgASC61 800 mg orally twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years of age at the time of screening
- Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion, as defined by RECIST 1.1
Key exclusion criteria (5 listed)
- Known symptomatic brain metastases requiring steroids
- Known history of another primary solid tumor
- Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs
- Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis
- Gastrointestinal disorders that might affect drug absorption
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 |
|---|---|---|
| ASC61 200 mg 1200mg of ASC61 orally once daily for cycles of 28 days | Drug | ASC61 200 mg 1 |
| ASC61 200 mg 2200 mg of ASC61 orally twice daily for cycles of 28 days | Drug | ASC61 200 mg 2 |
| ASC61 300 mg300 mg of ASC61 orally twice daily for cycles of 28 days | Drug | ASC61 300 mg |
| ASC61 400 mg400 mg of ASC61 orally twice daily for cycles of 28 days | Drug | ASC61 400 mg |
| ASC61 600 mg600 mg of ASC61 orally twice daily for cycles of 28 days | Drug | ASC61 600 mg |
| ASC61 800 mg800 mg of ASC61 orally twice daily for cycles of 28 days | Drug | ASC61 800 mg |
Primary outcome
Proportion of patients who experience DLTs
Time frame: From baseline to 28 days of treatment
The primary endpoint of this study is the proportion of the patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following treatment of PD1-PDL1 inhibitor
Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
Time frame: From first dose of ASC61 (Day 1) until 90 days after the last dose
Maximum serum concentration (Cmax) of ASC61, Area under the serum concentrations of ASC61 versus time curve (AUC) and Half-life (t1/2) of serum concentrations of ASC61)
4 secondary outcomes
Percentage of ASC61 subjects with a best response of Complete Response or Partial Response (Objective Response Rate)
Time frame: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
Percentage of ASC61 subjects with Complete Response, Partial Response, or Stable Disease (Disease Control Rate)
Time frame: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
Length of time that ASC61 subjects continue to respond to treatment without disease progression (Duration of response)
Time frame: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 1 year)
Length of time between first dosing and disease progression (Progression-Free survival)
Time frame: From first dose of ASC61 (Day 1) until death (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 ASC61 200 mg 1, ASC61 200 mg 2 and ASC61 300 mg in people with Advanced Solid Tumors, run by Ascletis Pharmaceuticals Co., Ltd. at 4 sites in United States.
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 5 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: finished, as of the sponsor's last update on 18 Dec 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience DLTs (time frame: From baseline to 28 days of treatment). 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 18 Dec 2025.