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New pill takes on Hard-to-Treat cancers in first human trial

NCT ID NCT05159700

Disease control Sponsor: Zhuhai Yufan Biotechnologies 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental oral drug called PRJ1-3024 in 39 adults with advanced solid tumors that have not responded to standard treatments. The main goal is to check safety and find the right dose. Researchers will also look for early signs that the drug may shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRJ1-3024 (oral capsule)
What this could lead to
If this drug is safe and shows signs of shrinking tumors, it could lead to a new treatment option for people with advanced solid cancers that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 39 participants. The main goal is safety, not effectiveness. Many drugs fail at this stage, and side effects may be serious.

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

39 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

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.

Key Inclusion Criteria: * Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable. * Male or non-pregnant, non-lactating female subjects age ≥18 years. * ECOG Performance Status 0\~2. * Has at least 1 measurable lesion as defined by RECIST 1.1 criteria . * Life expectancy of \>3 months, in the opinion of the Investigator. * Able to take oral medications and willing to record daily adherence to investigational product. * Adequate hematologic parameters unless clearly due to the disease under study. * Adequate renal and hepatic function * Able to understand and willing to sign a written informed consent form. Key Exclusion Criteria: * History of another malignancy * Known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * Significant cardiovascular disease * Known active HBV, HCV, AIDS-related illness. * Has received a live vaccine within 30 days * History of active autoimmune disorders or ongoing immunosuppressive therapy. * Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) . * Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.

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Conditions

The condition(s) this trial relates to.

cancer hereditary sensory and autonomic neuropathy neoplasm

As listed by the trial registrant

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

Advanced solid malignancies Advanced solid tumor

Contacts and locations

Locations

  • Christ Hospital

    Cincinnati, Ohio, 21073, United States

  • Mays Cancer Center

    San Antonio, Texas, 78229, United States

  • NEXT Oncology

    Austin, Texas, 73301, United States

  • NEXT Oncology

    Fairfax, Virginia, 22031, United States

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827, United States

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218, United States

More trials for these conditions

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