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New drug cocktail aims to tackle Hard-to-Treat cancers

NCT ID NCT06499350

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 1 time

Summary

This early-phase trial is testing a combination of two drugs—FC084CSA and tislelizumab—in people with advanced solid tumors that have stopped responding to standard treatments. The study aims to find the safest dose and see if the combo can control tumor growth. Only 33 participants will be enrolled, so results are very preliminary.

What this could mean

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

Active substance
FC084CSA (AXL inhibitor) combined with tislelizumab (PD-1 inhibitor)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early, small trial (33 people) focused on safety and dosing. The combination may not shrink tumors or could cause significant side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 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 to 75 years

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: 1. Aged 18 to 75 years old male and female. 2. Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed. 3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available. 4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed; 5. According to RECIST 1.1, there is at least one measurable lesion. 6. ECOG performance status 0-1. 7. Major organs are functioning well. Exclusion Criteria: 1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1). 2. Received anti-tumor therapy within 4 weeks before enrollment. 3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started. 5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods. 6. Central nervous system metastases with clinical symptoms. 7. With any situations that the researcher considers inappropriate to participate in this research.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

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