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New pill shows promise for Hard-to-Treat cancers

NCT ID NCT05287399

Disease control Sponsor: Ascletis Pharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new daily pill, ASC61, in 18 adults with advanced solid tumors that had stopped responding to standard treatments. The goal was to check the drug's safety and how the body processes it. Researchers looked for side effects and measured tumor response, but this is a very early step to see if the drug is safe enough for further testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Aug 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

Contacts and locations

Locations

  • California Cancer Associates for Research & Excellence (cCARE)

    Encinitas, California, 92024, United States

  • California Cancer Associates for Research & Excellence (cCARE)

    Fresno, California, 93720, United States

  • California Cancer Associates for Research & Excellence (cCARE)

    San Marcos, California, 92069, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.