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

NCT05287399 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ASC61-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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)

  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)

Study Arms (6)

ASC61 200 mg 1

EXPERIMENTAL

ASC61 200 mg orally once

Drug: ASC61 200 mg 1

ASC61 200 mg 2

EXPERIMENTAL

ASC61 200 mg orally twice daily

Drug: ASC61 200 mg 2

ASC61 300 mg

EXPERIMENTAL

ASC61 300 mg orally twice daily

Drug: ASC61 300 mg

ASC61 400 mg

EXPERIMENTAL

ASC61 400 mg orally twice daily

Drug: ASC61 400 mg

ASC61 600 mg

EXPERIMENTAL

ASC61 600 mg orally twice daily

Drug: ASC61 600 mg

ASC61 800 mg

EXPERIMENTAL

ASC61 800 mg orally twice daily

Drug: ASC61 800 mg

Interventions

ASC61 200 mg 1 DRUG

200mg of ASC61 orally once daily for cycles of 28 days

ASC61 200 mg 1

ASC61 200 mg 2 DRUG

200 mg of ASC61 orally twice daily for cycles of 28 days

ASC61 200 mg 2

ASC61 300 mg DRUG

300 mg of ASC61 orally twice daily for cycles of 28 days

ASC61 300 mg

ASC61 400 mg DRUG

400 mg of ASC61 orally twice daily for cycles of 28 days

ASC61 400 mg

ASC61 600 mg DRUG

600 mg of ASC61 orally twice daily for cycles of 28 days

ASC61 600 mg

ASC61 800 mg DRUG

800 mg of ASC61 orally twice daily for cycles of 28 days

ASC61 800 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

California Cancer Associates for Research & Excellence (cCARE)

Encinitas, California, 92024, United States

Location

California Cancer Associates for Research & Excellence (cCARE)

Fresno, California, 93720, United States

Location

California Cancer Associates for Research & Excellence (cCARE)

San Marcos, California, 92069, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 18, 2022
• Study Start: August 2, 2022
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (4)