Clinical trial NCT05287399: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Ascletis Pharmaceuticals Co., Ltd.
First posted: 2022-03-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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, and 600 mg BID are planned.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients who experience DLTs
timeFrame: From baseline to 28 days of treatment
measure: Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
timeFrame: From first dose of ASC61 (Day 1) until 90 days after the last dose
Secondary outcomes:
measure: Percentage of ASC61 subjects with a best response of Complete Response or Partial Response (Objective Response Rate)
timeFrame: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
measure: Percentage of ASC61 subjects with Complete Response, Partial Response, or Stable Disease (Disease Control Rate)
timeFrame: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
measure: Length of time that ASC61 subjects continue to respond to treatment without disease progression (Duration of response)
timeFrame: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 1 year)
measure: Length of time between first dosing and disease progression (Progression-Free survival)
timeFrame: From first dose of ASC61 (Day 1) until death (up to 1 year)
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Cancer Associates for Research & Excellence (cCARE)
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research & Excellence (cCARE)
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research & Excellence (cCARE)
state: California
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
Study officials:
References: