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

NCT ID: NCT05287399

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2025-01-17

Brief Summary

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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

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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

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASC61 200 mg 1

ASC61 200 mg orally once

Group Type EXPERIMENTAL

ASC61 200 mg 1

Intervention Type DRUG

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

ASC61 200 mg 2

ASC61 200 mg orally twice daily

Group Type EXPERIMENTAL

ASC61 200 mg 2

Intervention Type DRUG

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

ASC61 300 mg

ASC61 300 mg orally twice daily

Group Type EXPERIMENTAL

ASC61 300 mg

Intervention Type DRUG

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

ASC61 400 mg

ASC61 400 mg orally twice daily

Group Type EXPERIMENTAL

ASC61 400 mg

Intervention Type DRUG

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

ASC61 600 mg

ASC61 600 mg orally twice daily

Group Type EXPERIMENTAL

ASC61 600 mg

Intervention Type DRUG

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

ASC61 800 mg

ASC61 800 mg orally twice daily

Group Type EXPERIMENTAL

ASC61 800 mg

Intervention Type DRUG

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

Interventions

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ASC61 200 mg 1

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

Intervention Type DRUG

ASC61 200 mg 2

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

Intervention Type DRUG

ASC61 300 mg

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

Intervention Type DRUG

ASC61 400 mg

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

Intervention Type DRUG

ASC61 600 mg

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

Intervention Type DRUG

ASC61 800 mg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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California Cancer Associates for Research & Excellence (cCARE)

Encinitas, California, United States

Site Status

California Cancer Associates for Research & Excellence (cCARE)

Fresno, California, United States

Site Status

California Cancer Associates for Research & Excellence (cCARE)

San Marcos, California, United States

Site Status

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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ASC61-101

Identifier Type: -

Identifier Source: org_study_id