Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: ASC61 400 mg; Drug: ASC61 600 mg; Drug: ASC61 200 mg 2; Drug: ASC61 200 mg 1; Drug: ASC61 300 mg

• Registration Number: NCT05287399
• Lead Sponsor: Gannex Pharma Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Study Start: 2022-08-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ASC61 400 mg	ASC61 400 mg	ASC61 400 mg orally twice daily
ASC61 600 mg	ASC61 600 mg	ASC61 600 mg orally twice daily
ASC61 200 mg 2	ASC61 200 mg 2	ASC61 200 mg orally twice daily
ASC61 200 mg 1	ASC61 200 mg 1	ASC61 200 mg orally once
ASC61 300 mg	ASC61 300 mg	ASC61 300 mg orally twice daily

Primary Outcome Measures

Name	Time	Method
Proportion of patients who experience DLTs	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)	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)

Secondary Outcome Measures

Name	Time	Method
Percentage of ASC61 subjects with a best response of Complete Response or Partial Response (Objective Response Rate)	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)	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)	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)	From first dose of ASC61 (Day 1) until death (up to 1 year)

Trial Locations

Locations (2)

California Cancer Associates for Research & Excellence (cCARE); 🇺🇸 San Marcos, California, United States

Nebraska Cancer Specialists; 🇺🇸 Omaha, Nebraska, United States